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Physical Therapy Treatment Effectiveness for
Osteoarthritis of the Knee: A Randomized
Comparison of Supervised Clinical Exercise and
Manual Therapy Procedures Versus a Home
Program
Gail D Deyle, Stephen C Allison, Robert L Matekel,
Michael G Ryder, John M Stang, David D Gohdes,
Jeremy P Hutton, Nancy E Henderson and Matthew B
Garber
PHYS THER. 2005; 85:1301-1317.
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Physical Therapy Treatment
Effectiveness for Osteoarthritis of the
Knee: A Randomized Comparison of
Supervised Clinical Exercise and
Manual Therapy Procedures Versus a
Home Exercise Program
Background and Purpose. Manual therapy and exercise have not pre-viously been compared with a home exercise program for patients with osteo-arthritis (OA) of the knee. The purpose of this study was to compare outcomesbetween a home-based physical therapy program and a clinically based physicaltherapy program. Subjects. One hundred thirty-four subjects with OA of the kneewere randomly assigned to a clinic treatment group (n⫽66; 61% female, 39%male; mean age [⫾SD]⫽64⫾10 years) or a home exercise group (n⫽68, 71%female, 29% male; mean age [⫾SD]⫽62⫾9 years). Methods. Subjects in theclinic treatment group received supervised exercise, individualized manualtherapy, and a home exercise program over a 4-week period. Subjects in thehome exercise group received the same home exercise program initially, re-inforced at a clinic visit 2 weeks later. Measured outcomes were the distancewalked in 6 minutes and the Western Ontario and McMaster UniversitiesOsteoarthritis Index (WOMAC). Results. Both groups showed clinically andstatistically significant improvements in 6-minute walk distances and WOMACscores at 4 weeks; improvements were still evident in both groups at 8 weeks. By4 weeks, WOMAC scores had improved by 52% in the clinic treatment group andby 26% in the home exercise group. Average 6-minute walk distances had improved about 10% in both groups. At 1 year, both groups were substantiallyand about equally improved over baseline measurements. Subjects in the clinictreatment group were less likely to be taking medications for their arthritis andwere more satisfied with the overall outcome of their rehabilitative treatmentcompared with subjects in the home exercise group. Discussion and Conclusion.
Although both groups improved by 1 month, subjects in the clinic treatmentgroup achieved about twice as much improvement in WOMAC scores thansubjects who performed similar unsupervised exercises at home. Equivalentmaintenance of improvements at 1 year was presumably due to both groupscontinuing the identical home exercise program. The results indicate that ahome exercise program for patients with OA of the knee provides importantbenefit. Adding a small number of additional clinical visits for the application ofmanual therapy and supervised exercise adds greater symptomatic relief. [DeyleGD, Allison SC, Matekel RL, et al. Physical therapy treatment effectiveness forosteoarthritis of the knee: a randomized comparison of supervised clinicalexercise and manual therapy procedures versus a home exercise program. PhysTher. 2005;85:1301–1317.] Key Words: Exercise, Knee Osteoarthritis, Manual therapy, Physical therapy.
Gail D Deyle, Stephen C Allison, Robert L Matekel, Michael G Ryder, John M Stang, David D Gohdes,
Jeremy P Hutton, Nancy E Henderson, Matthew B Garber
Physical Therapy . Volume 85 . Number 12 . Osteoarthritis(OA)isthemostcommonjoint strength (loss of force-generating capacity of
disease causing disability, affecting more muscle),18–20 coronary heart disease,21 and depression.22 than 7 million people in the United States.1More disability and clinical symptoms result Several interventions are available for OA. Well-designed from OA of the knee than from any other joint.2,3 studies show that capsaicin cream, laser treatment, and Osteoarthritis of the knee is reported to be a major transcutaneous electrical nerve stimulation (TENS) health problem worldwide.4,5 decrease the pain associated with OA.23–25 Arthroscopicsurgery has not been shown to have a role in the The etiology of knee OA is not entirely clear, but its management of knee OA. Knee capsule injections of incidence increases with age and in women.6,7 Obesity is saline, tidal irrigation, and placebo surgery have all been a risk factor for the development and progression of shown to be equal to arthroscopy.26–28 Acetaminophen is knee OA and the need for total joint replacement.6,8,9 widely prescribed and considered to be low risk, but The association between physical activity and knee OA recent studies29,30 have shown minimal benefit for reduc- remains controversial.10–12 Underlying biomechanical ing the pain associated with OA. Nonsteroidal anti- factors also may predispose people to OA.13,14 Increased inflammatory drugs (NSAIDs) are frequently prescribed, incidence of OA has been reported in both the intact but they have significant side effects.31–33 Topical diclofe- and amputated limbs in people with amputations.15 nac has been found to decrease the pain of knee OA, Early degenerative changes predict progression of the with presumably fewer gastrointestinal side effects.34 disease.16,17 The disability and pain associated with knee Cyclooxygenase-2-selective inhibitors (coxibs) were ini- OA correlate with a loss of quadriceps femoris muscle tially thought to be the safer alternative to nonselective GD Deyle, PT, DPT, is Assistant Professor and Graduate Program Director, Rocky Mountain University of Health Professions, Provo, Utah; AssistantProfessor, Baylor University, Waco, Tex; and Senior Faculty, US Army–Baylor University Post Professional Doctoral Program in OrthopaedicManual Physical Therapy, Brooke Army Medical Center, San Antonio, Tex. Address all correspondence to Dr Deyle at 3 Sherborne Wood, SanAntonio, TX 78218-1771 (USA) ([email protected]).
SC Allison, PT, PhD, is Professor, Rocky Mountain University of Health Professions, and Adjunct Professor of Physical Therapy Education, ElonUniversity, Elon, NC.
RL Matekel, PT, DScPT, is Lieutenant Colonel, Army Medical Specialist Corps, and Chief, Physical Therapy, Madigan Army Medical Center, FtLewis, Wash.
MG Ryder, PT, DScPT, is Major, Army Medical Specialist Corps, and Officer-in-Charge, Primary Care Physical Therapy, Brooke Army MedicalCenter, Ft Sam Houston, Tex.
JM Stang, PT, DScPT, is Lieutenant Colonel, Army Medical Specialist Corps, and Chief, Physical Therapy, Ireland Army Community Hospital, FtKnox, Ky.
DD Gohdes, PT, MPT, is Lieutenant Colonel, Army Medical Specialist Corps, and Assistant Chief, Physical Therapy, Tripler Army Medical Center,Tripler AMC, Hawaii.
JP Hutton, PT, MPT, is Lieutenant Colonel, Army Medical Specialist Corps, and Chief, Physical Therapy, Eisenhower Army Medical Center, FtGordon, Ga.
NE Henderson, PT, PhD, is Physical Therapist, Steilacoom, Wash.
MB Garber, PT, DScPT, is Major, Army Medical Specialist Corps, and Assistant Chief, Physical Therapy, Brooke Army Medical Center.
All authors provided concept/idea/research design, writing, and consultation (including review of manuscript before submission). Dr Deyle, DrAllison, Dr Matekel, Dr Ryder, Dr Stang, LTC Gohdes, Dr Hutton, and Dr Garber provided data collection. Dr Allison and Dr Henderson provideddata analysis. Dr Deyle, Dr Matekel, Dr Ryder, Dr Stang, LTC Gohdes, and Dr Hutton provided subjects. Dr Deyle provided facilities/equipment.
Dr Deyle, Dr Matekel, Dr Ryder, Dr Stang, LTC Gohdes, Dr Hutton, and Dr Garber provided clerical support.
The study was approved by the institutional review board of Brooke Army Medical Center, Fort Sam Houston, Tex.
The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the viewsof the Department of the Army or the Department of Defense.
This article was received September 30, 2004, and was accepted May 18, 2005.
1302 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005 NSAIDs, but recent concerns have included gastrointes- 1. Knee pain and crepitus with active motion and morning tinal, cardiovascular, renal, and hepatic side effects.35–40 stiffness ⱕ30 min and age ⱖ38 y Glucosamine supplements are widely used, with some 2. Knee pain and crepitus with active motion and morning stiffness ⬎30 min and bony enlargement controversy with regard to their efficacy and long-term 3. Knee pain and no crepitus and bony enlargement benefits for people with knee OA.41,42 Ice massageimproves range of motion (ROM), function, and knee Figure 1.
Clinical criteria for the diagnosis of osteoarthritis of the knee.59 Sub-
strength, and cold packs decrease swelling in patients jects with examination findings consistent with any of the 3 cate- with knee OA.43,44 Hot packs or ultrasound are not gories were considered to have knee osteoarthritis. Sensitivity⫽89%, thought to be of therapeutic value.43,45 A growing body of evidence shows that exercise improvesknee joint function and decreases symptoms.46–57 Fur- reported by Deyle et al48 are reproducible in a multi- thermore, the findings of a recent study 48 suggest that center trial with different subjects and treating thera- physical therapy intervention including exercise may pists. Our hypothesis was that physical therapy consisting reduce the need for knee arthroplasty and intra-articular of manual therapy and supervised exercise conducted in injections. However, the most effective types and combi- the clinic would be more effective than an exercise nations of exercise and dosage are unclear. The setting program performed at home for improving function in which the exercises should be performed and the and decreasing pain and stiffness.
level of professional attention required to initiate andmaintain the exercise program also should be the sub- ject of further investigation.
Benefits have been reported with manual therapy tech- One hundred thirty-four subjects with OA of the knee niques used in combination with joint mobility and were randomly assigned to a clinic treatment group strengthening exercises.48,58 Falconer et al58 found (n⫽66; 26 male, 40 female; mean age [⫾SD]⫽64⫾10 improvements in motion (11%), pain (33%), and gait years) or a home exercise group (n⫽68; 20 male, 48 speed (11%) after 12 treatments of stretching, strength- female; mean age [⫾SD] 62⫾9). One of the investiga- ening, and mobility exercises combined with manual tors used a computer random-number generator to therapy procedures performed in a physical therapy determine group allocation. The randomization list clinic over 4 to 6 weeks. A comparison group that determined the sequence of enrollment folders con- received the same exercise and manual therapy interven- cealed in a locked cabinet. After a potential subject tions plus therapeutic doses of ultrasound demonstrated agreed to participate, a research assistant opened the no additional improvement.
cabinet to retrieve the next folder in sequence and thenmade allocation as indicated in the folder. All folders In a controlled, randomized, single-blinded study, Deyle were identical in external appearance; each folder con- et al48 demonstrated that manual therapy techniques tained a sheet of paper indicating group assignment that and exercises applied by physical therapists for 8 clinical could be accessed only by opening the folder. Subjects visits produced a 52% improvement in self-reports of were either referred by their physicians for physical function, stiffness, and pain as measured by the Western therapy or were self-referred.
Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scale and a 12% improvement in 6-minute Subjects who were admitted to the study were diagnosed walk test scores. A placebo control group that received with OA of the knee based on clinical criteria developed equal clinical attention showed no improvement in by Altman59 (Fig. 1), which he found to be 89% sensitive WOMAC scores or 6-minute walk test scores.
and 88% specific. Additional inclusion criteria wereeligibility for military health care and no physical impair- The need for cost effectiveness throughout the health ment unrelated to the knee that would prevent the care system emphasizes the importance of knowing subject from safely participating in any aspect of the whether patients require numerous visits to a physical study. All subjects were required to have sufficient therapist or whether they might receive a similar benefit English language skills to complete the pain, stiffness, from a well-designed home program. The primary pur- and functional assessment questionnaire. Subjects were pose of this study was to determine the effectiveness of a excluded if they could not attend the required number clinically applied treatment that included exercise and of visits, had received a cortisone injection to the knee manual therapy compared with an exercise program joint within the previous 30 days, or had a surgical performed at home for OA of the knee. A secondary procedure on either lower extremity within the past 6 purpose was to determine whether the high levels of months. Subjects were instructed to continue taking any improvement in pain, stiffness, and functional ability medication that had been initiated 30 days or more priorto enrollment in the study.
Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1303 tion. For example, if the examination revealed that a Informed consent was obtained after screening for inclu- subject was limited in the ability to perform a full squat sion and exclusion criteria. Subjects in both groups or if the subject experienced pain with that activity, provided descriptive data for age, sex, height, weight, squatting would be reassessed after manual techniques duration of symptoms, presence of symptoms in one or intended to improve knee flexion. If the symptoms both knees, previous surgery, medications, exercise fre- associated with squatting were subsequently decreased quency, and perceived exertion levels. Sunrise and or the range of the squatting motion improved, that weight-bearing anteroposterior and lateral knee radio- technique was considered to have a positive effect and graphs were obtained and examined by radiologists for a would be continued at subsequent sessions. General radiographic severity rating for OA of the knee,60 with improvements from session to session in these quick scores ranging from 0 (least severe) to 4 (most severe).
functional tests also were considered a positive overallresponse to the intervention in either treatment group.
All enrollment, data collection, and clinic treatment A neurological examination that included muscle sessions were conducted in the physical therapy clinics at strength testing, muscle stretch reflex testing, and sen- 3 military hospitals: Brooke Army Medical Center in sory testing was performed if there were complaints of Texas, Madigan Army Medical Center in Washington, weakness, radiating pain, or altered sensation in the and Martin Army Community Hospital in Georgia.
lower extremities.
Radiographs were obtained in the radiology departmentof each military hospital. Physical therapist assistants Subjects in the clinic treatment group attended 8 treat- trained to be research assistants obtained the blinded ment sessions in the physical therapy clinic. Manual pretreatment measurements. Training of the research therapy programs were individualized based on the assistants included review of the WOMAC procedure results of the examination. The manual therapy tech- manual61 and practice administering the WOMAC.
niques, consisting of passive physiological and accessory Training for the 6-minute walk test included using a movements, muscle stretching, and soft tissue mobiliza- stopwatch, marking laps on a preprinted 6-minute walk tion, were applied by the treating physical therapist test form, and measuring the distance walked in an primarily to the knee and surrounding structures (Tabs.
incrementally marked long hallway under simulated test 1 and 2). Detailed descriptions of the manual therapy techniques and intervention philosophy utilized in thisstudy are available in manual therapy textbooks.68,69 The primary outcome measure in this study was the Similar manual treatments also were administered to WOMAC.61 Secondary outcome measures were a timed the lumbar spine, hip, and ankle if these areas exhibited 6-minute walk test, the frequency of knee injections or a limitation in either active or passive movement and knee surgery, medication use, and overall satisfaction were judged to contribute to the overall lower-extremity with the rehabilitative treatment. The WOMAC consists of 24 questions, each corresponding to a visual analogscale, designed to measure patients' perceptions of pain, In addition to receiving manual therapy treatments, stiffness, and dysfunction. High WOMAC scores reflect subjects in the clinic treatment group performed a high self-perceptions (greater severity) across the 3 standardized knee exercise program at each treatment domains measured by the scale. The WOMAC, which was session. This program consisted of active ROM exercises, specifically designed to evaluate patients with OA of the muscle strengthening, muscle stretching, and riding a hip or knee, has been shown to be a highly responsive, stationary bicycle. A physical therapist or physical ther- multidimensional outcome measure that yields moder- apy technician supervised these exercises. The number ately reliable and valid scores.62–64 The timed 6-minute of strengthening exercise bouts and stationary bicycle walk test measures the distance a person walks in 6 riding time were increased or decreased by the treating minutes and has been demonstrated to yield reliable physical therapist based on subject response. The exer- measurements of functional exercise capacity; it is fre- cise program was based on the best available evidence quently used in OA-related trials.46,65–67 for the most efficient methods of producing the desiredeffects of increasing strength, flexibility, and ROM at the initiation of this study.71–76 Subjects were examined for received a standardized clinical examination. The exam- adverse signs and symptoms such as increased pain, joint ination included active and passive ROM assessments, effusion, and increased skin temperature over knee manual muscle testing, and palpation of the lumbar joints at each clinic visit. All elements of hands-on spine, hip, knee, and ankle. Simple functional tests treatment and exercise were progressed only if the (eg, squatting, step-ups) that limited or reproduced symptoms and signs of OA were decreasing. If any symptoms were used to obtain daily baseline measure- soreness lasted more than a few hours after the interven- ments to help assess the effect of the manual interven- tion, the regimen was decreased accordingly for that 1304 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005 Table 1.
Comparison of Interventions by Intervention Group
Strengthening exercise Strengthening exercise Stretching exercise Stretching exercise No manual therapy Level of exercise supervision 1 exercise instruction session Level of exercise supervision 2 exercise instruction 7 supervised exercise a Home stationary bicycle riding in both exercise groups was allowed if it was part of the participant's exercise program before the study. Participants in the homeexercise group were not specifically instructed to ride a stationary bicycle, nor was it recorded on the exercise adherence log. ROM⫽range of motion.
subject. Subjects in the clinic treatment group per- for another blinded assessment of WOMAC scores and formed the same home exercise program as the home 6-minute walk test measurements. Subjects in both exercise group each day that they were not treated in the groups were instructed to refrain from their home physical therapy clinic.
exercises and their daily walk on the day of the secondassessment. Assessments were performed at the same The home exercise group received detailed verbal and time of day as the pretest to help control for daily cycles hands-on instruction in a home-based program of the in pain and stiffness.
same exercises as the clinical treatment group. Similar tothe subjects who received clinical treatment, subjects in During the second 4-week period, subjects in both the home exercise group were instructed that pain groups continued their daily home exercise program. At should be avoided in all exercises except in the case that 8 weeks, both groups of subjects returned for a third pain or stiffness decreased with each repetition. Each assessment of WOMAC scores and 6-minute walk test subject received a detailed supporting handout contain- measurements. At 1 year, subjects were contacted and ing instructions and photographs of the exercises. A queried about knee injections, knee surgeries, medica- home program adherence log was maintained by each tion use, and overall satisfaction with outcomes of their subject. Subjects in the home exercise group were rehabilitative treatment. WOMAC scores and 6-minute allowed to ride a stationary bicycle if they stated that walk test measurements were obtained at 1 year for those riding a bicycle was currently part of their exercise subjects who were able to return to the clinic for routine or if they could not walk for safety reasons.
Riding of the stationary bicycle was not recorded on theexercise adherence log for the home exercise group.
The sample size was determined a priori by a statistical The details of the manual therapy and exercise interven- power calculation based on anticipated group differ- tions for both groups are shown in Tables 1 through 5.
ences in WOMAC scores at 4 weeks. For this calculation,the standard deviation was estimated to be 400 mm, the A follow-up examination was performed for the home minimal clinically important difference between groups exercise group 2 weeks after the initial visit. Examiners was defined as 200 mm (about 20% of anticipated checked for adverse signs and symptoms such as average baseline score), and statistical power was 80% increased pain, joint effusion, and increased skin tem- with approximately 64 subjects per group.
perature over knee joints. The exercise log was reviewed,the subjects were again supervised performing the Data Analysis home-based program, and observed performance defi- Data from the initial measurement session were analyzed ciencies were corrected. Exercises were progressed only to determine whether significant group differences if the symptoms and signs of OA were stable or decreasing.
existed using independent t, Mann-Whitney U, andchi-square tests for ratio, ordinal, and categorical vari- Neither group of subjects was aware of the intervention ables, respectively. All data analyses were performed with that the other group was receiving. Subjects in both SPSS for Windows (version 10.1).* Descriptive data groups were instructed to take a daily walk at a comfort-able pace and gradually progressed distance. After 4weeks, subjects from both groups returned to the clinic * SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606.
Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1305 Table 2.
Common Knee Impairments Addressed by Manual Therapy
Loss of knee extension Manual mobilization through range of motion (ROM) Mobilization grades III and IV to III⫹⫹ and IV⫹⫹ and knee extension at end range 2–6 bouts of 30 s per manual technique Clinical observation: this manual intervention may Knee extension with valgus or abduction provide near-immediate decrease of symptoms Knee extension with varus or adduction and may be approached with relatively morevigor than knee flexion Loss of knee flexion Manual mobilization through ROM and knee flexion Mobilization grades of III- and IV- to III⫹ and IV⫹ 2–6 bouts of 30 s per manual technique Clinical observation: pain with end-range knee Knee flexion plus medial (internal) rotation flexion may be due to degenerative meniscaltears; end-range techniques should be utilizedwith caution Loss of patellar glides Manual mobilization of the patella in 5°–10° of knee Mobilization grades of IV to IV⫹⫹ 2–6 bouts of 30 s per manual technique Clinical observation: some patients may be intolerant of even slight compressive forces over the patella; therapist hand placement is Manual stretches at end length of the muscle Sustained manual stretches of 12–30 s duration Quadriceps femoris repeated 1–3 times per muscle Clinical observation: the lumbar spine should be manually stabilized and protected during all extremity stretches, particularly hip flexor stretches; many of these patients also will have Tensor fasciae latae and the iliotibial band arthritic changes in the spine, and symptomscan be increased without care in positioning Soft tissue tightness Soft tissue mobilization Circular fingertip and palm pressure mobilization Suprapatellar and peripatellar regions at the depth of the capsule or retinaculum for Medial and lateral joint capsule 1–3 bouts of 30 s per area Clinical observation: the soft tissue work in the popliteal fossa seems to work best whenperformed slowly with occasional sustainedpositions of 10–12 s, this technique works wellwhen combined with the manual mobilizationsinto knee extension analysis and tests for the assumptions of normality and possible predictors among baseline variables were homogeneity of variance were followed by a 2 ⫻ 3 included in a forced-entry analysis: treatment group assignment, age, height, weight, sex, duration of symp- (MANOVA) with an alpha level of .05 for the subset of toms, self-rating of physical activity level, days per week 120 study participants who provided all data at baseline, of aerobic activity, bilaterality of symptoms, use of med- 4 weeks, and 8 weeks. The independent variables for the ications, severity of radiographic findings, and initial MANOVA were group (with 2 levels) and time (with 3 scores for the WOMAC and the 6-minute walk test. The levels). The 2 dependent variables were WOMAC scores WOMAC scores and 6-minute walk test measurements and 6-minute walk test distances. Subsequent 2 ⫻ 3 obtained at the 4-week follow-up were entered as depen- univariate analyses of variance (ANOVAs) for each dent variables for the regression analyses. An intention- dependent variable were performed with a Bonferroni- to-treat analysis was conducted by carrying the last corrected alpha level of .025. Post hoc analyses of signif- obtained measurements forward for those subjects who icant group ⫻ time interaction effects were performed did not complete all aspects of the study.
with the Tukey multiple-comparison procedure.
In order to investigate the potential for confounding Of the 134 subjects initially enrolled in the study (Fig. 2), variables, a separate multiple regression model was cre- 60 subjects in the clinic treatment group and 60 subjects ated for each outcome variable. In each model, 13 in the home exercise group completed all treatment and 1306 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005 Table 3.
Patient Exercise Program: Strengthening Exercises
Statis quad sets in knee extension Hold each contraction for 6 s with a Patient is positioned fully supine or supine supported 10-s rest between repetitions on elbows with the knee in full extension Patient contracts the quadriceps femoris muscle and pushes the knee down while maintaining the footin full dorsiflexion Standing terminal knee extension Perform 3⫻ per week Hold each contraction for 3 s Patient stands with a resistive band or a cuff from a weighted pulley mechanism behind a slightly Increase resistance as tolerated Patient contracts the gluteal and quadriceps femoris muscles to fully straighten the hip and knee Patient performs one of the following activities 3⫻ ordered from least to most Patient should progress to the most challenging activity that he or she can successfully completewith minimal or no pain Seated leg presses Patient is seated holding a resistive band in both Hold each contraction 3 s with knee as straight as possible Patient places his or her foot against the band, then Slowly return to starting position and straightens the knee by pushing the foot down repeat for a 30 s bout.
and forward by contracting the gluteal and Progress to bands of increasing quadriceps femoris muscles resistance and additional bouts Partial squats weight-lessened Patient stands with arm support as needed Hold each contraction 3 s with hips and with arm support as needed Patient performs a partial squat, keeping the knees knees as straight as possible centered over the feet Return to standing by contracting the quadriceps Progress to full body weight without femoris and gluteal muscles support and additional bouts Patient stands in front of a low step Slowly repeat for 30 s Patient places foot of involved leg on step and Progress to increased height of the step brings body over foot to stand on the step and additional bouts Use as little push-off assistance from the contralateral Alternate legs if both knees are involved Step down with the contralateral foot testing at 0, 4, and 8 weeks. In the clinic treatment group, 1 subject withdrew due to unrelated medical completers in each group are given in Table 6. Table 7 reasons, 2 subjects were disqualified after receiving knee contains mean scores with 95% confidence intervals injections, 1 subject changed medications during the (CIs) for the dependent variables measured at 0, 4, and study, and 1 subject failed to return for unknown 8 weeks for the completer subjects. Medication use by reasons. The 6-minute walk test measurement for the subjects in each group of completers is presented in 8-week testing session was unavailable for 1 additional subject in the clinic treatment group. In the homeexercise group, 3 subjects moved from the area, 1 subject For subjects who completed all aspects of the study, the changed medications during the study, 1 subject with- randomization procedure resulted in reasonably homog- drew to receive shoulder surgery, 1 subject was disqual- enous groups at the outset of the study (Tab. 6). The 14 ified after receiving cortisone injections to the knee, and subjects who failed to return for the 4-week or 8-week 2 subjects failed to return for unknown reasons. No measurement session appeared to differ from the sub- subjects were discontinued due to lack of adherence to jects who completed the study, as measured by several the treatment regimen. All 120 subjects who completed variables. However, the statistical tests revealed signifi- the study attended all clinical appointments and cant differences only for the initial WOMAC scores, reported for testing at 0, 4, and 8 weeks. The other 14 which were about 22% worse (P⫽.03) for the subjects subjects reflect an overall dropout rate of 11%: 9% in the who did not complete the study, and for radiographic clinic treatment group and 12% in the home exercise severity scores (P⫽.002) (median⫽2 for the subjects who completed the study and median⫽3 for the subjects who Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1307 Table 4.
Patient Exercise Program: Stretching Exercises
Standing calf stretch Hold for 30 s and repeat 3⫻ Patient stands with the heel of the foot on the ground behind the patient; the toes pointstraight ahead The patient leans forward until a moderate pull is perceived in the calf musculature The patient may use his or her arms for support against a wall or furniture as needed Supine hamstring muscle stretch Hold for 30 s and repeat 3⫻ Patient is positioned supine with the contralateral Clinical observation: if radicular symptoms are lower extremity maintained as straight as produced, decrease or eliminate the ankle dorsiflexion or the intensity of the stretch The ipsilateral hip is flexed to 90°The knee is straightened and the proximal lower leg supported with the hands until a moderatepull is perceived in the posterior thigh and calf The ipsilateral ankle should be dorsiflexed Prone quadriceps femoris Hold for 30 s and repeat 3⫻ Patient is positioned prone with both hips and Clinical observation: hamstring muscle cramping may occur if the patient attempts A strap is placed around the ipsilateral ankle to actively bend the knee; to reduce this and brought posteriorly and superiorly over possibility, always use the strap to passively the ipsilateral shoulder The patient grasps the strap in the ipsilateral Maintain a gentle stretch and comfortable hand and bends the knee by straightening his position for the lumbar spine or her elbow and pulling on the strap Hard stretching will frequently create lumbar The knee is progressively flexed until a gentle symptoms in this population stretch is perceived in the anterior thigh Table 5.
Patient Exercise Program: Range of Motion Exercises
Knee in mid-flexion to full-extension Performed once daily Two 30-s bouts with 3-s hold at end Patient is positioned supine or supine supported Clinical observation: these exercises work Knee is brought to 45° of flexion with the best if performed on a smooth surface ipsilateral foot sliding on the surface that the such as a hardwood or linoleum floor patient is lying on or if a sliding board is used The knee is then fully extended with a strong quadriceps femoris muscle contractionagainst any limitation to full knee extension Knee in mid-flexion to full-flexion Performed once daily Two 30-s bouts with 3-s hold at end Patient is positioned supine or supine supported Clinical observation: pain with end-range Knee is brought to full flexion with assistance of knee flexion may be due to the upper extremities or a strap degenerative meniscal tears A gentle challenge to end-range flexion is Over-pressure to end range should be applied with caution Stationery bicycle Performed once daily 5 min, increase time as tolerated Knees should be at nearly full extension at Clinical observation: some patients are bottom of pedal stroke intolerant of the stationary bicycle, andclinical judgment is required tocontinue the activity 1308 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005

The assumptions of normality andhomogeneity of variance were met forboth WOMAC scores and 6-minutewalk test measurements. For the 120subjects who provided data at 0, 4, and8 weeks, the MANOVA revealed agroup ⫻ time interaction effect (P⫽.001), suggesting that changes inaverage scores over time depended ontreatment group assignment. Subse-quent univariate ANOVAs also demon-strated a group ⫻ time interactioneffect for the WOMAC scores (P⫽.001)but not for the 6-minute walk test dis-tances (P⫽.199). The nonparallel plotsof the average WOMAC scores (Fig. 3)reflect the differential effect over timeof the clinic treatment and home exer-cise treatment on this outcome vari-able. In contrast, the relatively parallelplots of the average distances walkedreflect the lack of an interaction effectfor this variable (Fig. 4). For both theWOMAC scores and the 6-minute walktest measurements, there was a statisti-cally significant (P⬍.001) main effectfor time, reflecting an improvementfrom average initial values to thoserecorded at 4 weeks.
Post hoc pair-wise comparisons of meanscores revealed that the 2 groups ofsubjects who completed the study werehomogenous at the time of initial test-ing for WOMAC scores and 6-minutewalk test distances (P ⬎.05). Comparedwith initial 6-minute walk test distances,both groups improved, on average,about 40 m (about 10%) at 4 weeks(95% CI⫽30 – 48 m) and did notchange substantially between 4 and 8 Figure 2.
weeks (Tab. 7). Both groups also Flow chart describing the progress of subjects through the trial. OA⫽osteoarthritis, improved in average WOMAC scores DV⫽subjects for whom the dependent variables were measured.
between baseline and 4 weeks, but theclinic treatment group improved abouttwice as much as the home exercise did not complete the study) (Tab. 6). Durations of group. The average 4-week WOMAC score improved symptoms appeared to be longer but were not signifi- 52% (535 mm, 95% CI⫽426 – 644 mm) for the clinic cantly different for the subjects who did not complete treatment group and 26% (270 mm, 95% CI⫽193–346 the study (P⫽.43). This apparent difference in mean mm) for the home exercise group. Neither group duration was attributable primarily to one subject who reported symptoms lasting 564 months. Upon removing between 4 weeks and 8 weeks. Average WOMAC scores the outlier, mean duration of symptoms for the subjects for the clinic treatment group were 263 mm better (95% who completed the study was 74 months versus 71 CI⫽93– 432 mm) than those for the home exercise months for the subjects who did not complete the study group at 4 weeks and 217 mm better (95% CI⫽34 – 400 mm) at 8 weeks (Tab. 7). The multiple regression Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1309 Table 6.
Baseline Characteristics: Descriptive Statistics and Group Comparisons
Duration of symptoms (mo) WOMACa score Distance walked, 6 min (m) Bilateral symptoms Days/week of vigorous physical activity Severity of radiographic a WOMAC⫽Western Ontario and McMaster Universities Osteoarthritis Index.
Table 7.
Group Comparisons: Means and 95% Confidence Intervals (CIs) for the Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC) and the 6-Minute Walk Test at 0, 4, and 8 Weeksa
Clinic treatment group Home exercise group 6-minute walk test (m) Clinic treatment group Home exercise group a Includes only subjects who completed testing at 8 weeks. Clinic treatment group: n⫽60; home exercise group: n⫽60.
analysis revealed no meaningful influence of the poten- that did not differ substantially from the results of the tial confounding variables on the outcome scores.
analysis for the 120 subjects who completed the study. In WOMAC subscale analyses also were conducted for the intention-to-treat analysis, both groups improved those subjects who adhered to protocols through week 8.
about 9% in average 6-minute walk test distances at 4 Results were consistent and similar to the results of the weeks; average 4-week WOMAC scores were improved total WOMAC score analysis, with significant group ⫻ 45% for the clinic treatment group and 24% for the time interaction effects (Pⱕ.004) for each of the pain, home exercise group.
stiffness, and function subscales (Fig. 5).
All 120 subjects who completed testing through 8 weeks The results of the intention-to-treat analysis conducted were contacted 1 year after enrollment into the study. By for all 134 subjects enrolled in the study yielded results 1 year, 5 subjects (8%) in the clinic treatment group and 1310 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005

Table 8.
Medication Usea in the Clinic Treatment Group and Home Exercise Group
Clinic Treatment Group Completers (nⴝ60)
Home Exercise Group Completers (nⴝ60)
No. of Subjects
% of Subjects
No. of Subjects
% of Subjects
Codeine phosphate a Use of medication was documented but not controlled in this study. Invasive cointerventions such as cortisone injections or surgical procedures were grounds forremoval from the study.
b G.D. Searle & Co, Div of Pfizer, 235 E 42nd St, New York, NY 10017-5755.
c Mylan Pharmaceuticals Inc, 781 Chestnut Ridge Rd, PO Box 4310, Morgantown, WV 26504-4310.
d GlaxoSmithKline, Five Moore Dr, Research Triangle Park, NC 27709.
e LKT Laboratories Inc, 2233 University Ave W, St Paul, MN 55114-1629.
Figure 3.
Figure 4.
Average Western Ontario and McMaster Universities Osteoarthritis Average distance walked in 6 minutes at initial visit, 4 weeks, and 8 Index (WOMAC) scores at initial visit, 4 weeks, and 8 weeks. Lower weeks. Closed circles represent the clinic treatment group; open circles scores indicate perceived improvement in pain, stiffness, and function.
represent the home exercise group. On average, subjects in both groups Closed circles represent the clinic treatment group; open circles repre- improved over the 8-week period (P⬍.001). CI⫽confidence interval.
sent the home exercise group. Among subjects who completed the study,those in the clinic treatment group had a greater average improvementin WOMAC scores over the 8-week period (P⬍.001) than those in the testing at 1 year to determine whether the improvements home exercise group. CI⫽confidence interval.
in 6-minute walk test distances and the WOMAC scoresat 8 weeks were still evident 1 year after the intervention.
4 subjects (7%) in the home exercise group had received At the 1-year follow-up, average improvements in a total knee arthroplasty. Two subjects (3%) in the WOMAC scores and 6-minute walk test distances were clinical treatment group and 2 subjects (3%) in the still significantly improved. Compared with baseline home exercise group had knee arthroscopy. Two sub- scores, average 1-year WOMAC scores were 32% better jects (3%) in the clinic treatment group and 1 subject in the clinic treatment group and 28% better in the (2%) in the home exercise group received steroid home program group. However, after 11 months of identical home program regimens, both groups wereequally improved over baseline WOMAC measurements.
Among the 120 subjects who completed testing through8 weeks, 45 subjects in the clinic treatment group and 49 Subjects contacted at 1 year responded to a 5-point subjects in the home exercise group were available for Likert-type question asking how satisfied they were with Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1311

home exercise group. Improvements and between-group differences seen at 4 weeks were still measurableat 8 weeks. The benefits of a 4-week intervention werenot lost for either group during an intervening monthwith no treatment other than continued home exercises.
Subjects in the clinic treatment group appeared to bemore satisfied with the overall outcome of their rehabil-itative treatment than subjects in the home exercisegroup. These results suggest that clinical interventionconsisting of manual therapy and supervised exercisewas more effective than a home exercise program forincreasing function and decreasing pain and stiffnessover an 8-week period.
The difference between groups is likely attributable tothe additional effects of the clinical intervention consist- Figure 5.
ing of manual therapy, stationary bicycling, and supervi- Average Western Ontario and McMaster Universities Osteoarthritis sion of the exercises that the other group was perform- Index (WOMAC) subscale scores at initial visit, 4 weeks, and 8 weeks.
ing unsupervised at home. Deyle et al48 demonstrated no Lower scores indicate perceived improvements in pain, stiffness, andfunction. Closed circles represent the clinic treatment group; open circles significant change in WOMAC scores or 6-minute walk represent the home exercise group. The upper pair of plots represent test measurements in patients with knee OA who mean scores for the function subscale, the middle pair of plots represent received a clinically applied placebo treatment.
mean scores for the pain subscale, and the lower pair of plots representmean scores for the stiffness subscale. Among subjects who completed The clinical intervention was more expensive than the the study, those in the clinic treatment group had greater averageimprovements, with all 3 WOMAC subscale scores over the 8-week home intervention. Per-visit reimbursement for the clin- period (Pⱕ.004) than those in the home exercise group.
ical physical therapy interventions would range from $83for Medicare to $129 for commercial reimbursementrate. Therefore, the cost for 2 to 3 visits to initiate and the overall result of their rehabilitative treatment. Poten- maintain the home program is minimal. The difference tial responses were: "not at all satisfied," "a little satis- for 8 clinical visits in the clinic treatment group versus 2 fied," "a fair amount satisfied," "much satisfied," and clinical visits in the home program group would range "very much satisfied." Subjects in the clinic treatment from $498 to $774. These additional costs are compara- group indicated a greater level of satisfaction (P⫽.018) ble to the costs of other interventions such as the cost of than those in the home exercise group. Fifty-two percent a series of viscosupplementation injections, and they are of those in the clinic treatment group said they were less than one tenth of the cost of a total knee replace- "very much satisfied" with their outcomes compared with ment.78 The question then becomes whether twice the only 25% in the home exercise group. Sixteen percent of level of improvement in the WOMAC score over a period those in the home exercise group stated they were "a from 8 weeks to less than 1 year merits the additional little satisfied" or "not at all satisfied" compared with only 5% in the clinic treatment group.
The results observed in the clinic treatment group in this Subjects contacted at 1 year also were asked whether they study are nearly identical to those previously reported in were taking any medications for their OA. Sixty-eight an earlier study for the same intervention.48 In both percent of the subjects in the home exercise group were studies, subjects in the clinic treatment groups improved taking medications compared with 48% in the clinic an average of about 50% in WOMAC scores and about treatment group (P⫽.03).
10% in 6-minute walk test distances over the 4-weekperiod of active treatment (Fig. 6). The reproducibility of these observed treatment effects is apparent from Both treatment groups obtained successful outcomes, as nearly identical improvements for the clinical treatment measured by significant reductions in WOMAC scores groups in these 2 studies that enrolled completely dis- and improvement in 6-minute walk test distances over a tinct sets of subjects and used distinct sets of treaters and 4-week period. The reductions in WOMAC scores in both groups exceeded the 20% to 25% levels suggestedas minimally meaningful by Barr et al.77 The post- The reproduction of these findings is important to the treatment WOMAC scores in the group who received management of patients with OA of the knee. The level biweekly treatments in the physical therapy clinic were of functional improvement with this clinical treatment markedly better than the WOMAC scores seen in the 1312 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005

in the clinical treatment group to the level of the homeexercise group is presumably due to withdrawing theclinical sessions consisting of manual therapy, stationarybicycling, and supervised exercise. Both groups contin-ued the common home exercise program and main-tained an equal level of improvement.
Typically, when manual therapy and reinforcing exer-cises are utilized in a clinical setting, periodic follow-upappointments help maintain the effects of the interven-tion. It will be important to determine the optimalfrequency of follow-up treatment sessions required tomaintain the higher level of improvement realized from Figure 6.
clinical treatment in this study. The practice of establish- Average distances walked and average Western Ontario and McMas- ing periodic recheck appointments or allowing the ter Universities Osteoarthritis Index (WOMAC) scores at initial visit, 4 patient to contact the physical therapist when relief from weeks, and 8 weeks from 2 separate groups of subjects who received manual treatment and reinforcing exercise diminishes identical manual therapy plus supervised exercise treatments from 2studies with similar research designs. The upper set of plots represents appears appropriate on the basis of the results of this average 6-minute walk test distances scaled on the right axis; the lower study. The 8 clinical visits also might be spread more set of plots indicates average WOMAC scores, scaled on the left axis.
evenly over a longer period in order to sustain the effects Closed triangles represent the subjects from the current study (n⫽60); of manual therapy. Some subjects derived benefit after open triangles represent subjects from the 2000 study by Deyle et al48 only 2 to 4 interventions; for these subjects, the remain- (n⫽33). Both sets of plots combine to demonstrate the reproducibility ofthese results.
ing clinical sessions could have been distributed over alonger period of time. Some authors82,83 have advocatedthe use of periodic physical therapy treatment for program of manual therapy and supervised exercise is chronic conditions and have compared this strategy with greater than has been reported for other conservative the use of other therapeutic approaches, including use treatments24,53,54 and has been compared with improve- of medications for chronic conditions.
ments seen after total knee arthroplasty.79 The treatment effects associated with other common The benefit from the comprehensive clinically instruct- interventions for knee OA also are known to diminish ed home exercise program in the current study is over time and may be additionally associated with signif- consistent with the highest levels of benefit from exer- icant side effects. Viscosupplementation is a widely used cise reported in the previously cited studies. This benefit and recommended knee OA therapy.84 Individual stud- accrued to patients in the current study with only 2 clinic ies that have demonstrated benefit for hyaluronic acid visits, whereas previously reported home regimens also revealed a return to near-baseline levels after 3 to 6 required a range of 1 to 12 (mean of 4) clinical visits for months.85–88 Intra-articular hyaluronate injections have instruction and reinforcement to yield similar or lesser been associated with calcium pyrophosphate dehydrate benefits.46,47,49,51,55,56,80,81 The success of the home pro- arthritis and inflammatory flares of other types.89,90 gram may be attributable to any or all of the features Intra-articular steroids have been associated with designed into the program: careful instruction, minimal increased risk for septic arthritis.91 Single intra-articular exercise performance time, an adherence log, a high- injections of steroids for knee OA have been demon- quality exercise folder, and a comprehensive set of strated to be equivalent to placebo. Multiple injections exercises addressing muscle tightness, limitations in have produced pain relief indistinguishable from a pla- joint movement, muscle weakness, and general fitness.
cebo at 4 to 6 weeks.86 Although the exercises of the subjects in the clinictreatment group were observed and corrected as neces- It would be important to know whether the subjects who sary, subjects in the home exercise group exercised received the interventions in this study were better without the supposed benefits of frequent supervision; prepared for total joint replacement surgery or had they received one-to-one supervision only initially and at lower postoperative complication rates. In general, refer- the 2-week follow-up visit.
ring physicians and other clinicians need to knowwhether short-term physical therapy interventions for The WOMAC scores at the 1-year follow-up measure- chronic conditions such as OA of the knee can influence ment were still improved over baseline measurements, eventual utilization of more invasive treatments such as although group differences on this scale that were injections and joint arthroplasties. More attention needs evident at 4 weeks and 8 weeks were not observed at 1 to be placed on studying the effects of combinations of year. The reduction of the treatment effect after 1 year Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1313 therapies such as glucosamine use, viscosupplementa- tion group in this study and yet failed to demonstrate any tion, and physical therapy. More work also is needed to change over time.
further define the relative benefits of home programsand intensive clinical intervention in physical therapy.
Results of this study should be reasonably generalizableto patients with knee OA of either sex with similar ages Both groups in the current study improved their walking and OA severity levels. There is a common perception distance to about the same extent, presumably because that studies of patients in military health care facilities of the identical instructions regarding a daily walking may suffer from limited external validity because of program. This finding is consistent with results from a cultural differences and unique factors related to subject previous study 48 in which placebo group patients adherence to treatment regimens. We do not think it is received no instructions for a walking program and did likely that the high level of benefit demonstrated for not improve their walking distances.
either treatment group was due to any factors related tomilitary service. Foremost, 63% of the subjects in this The combination of manual therapy and exercise has study were family members who had never served in the been shown to reduce the need for total knee replace- military. Only one subject was on active duty during the ment and steroid injections, with a number needed to study. The mean body mass index (BMI) for the former treat of 7 when compared with placebo intervention.48,78 military subjects (BMI⫽30.6, 95% CI⫽29.0 –32.1) was In the current study, there was not a difference in the not significantly different from that of subjects who had surgical rates between the 2 effective interventions. This never served in the military (BMI⫽32.5, 95% CI⫽30.9 – finding may be due, in part, to the fact that both groups 34.0); the subjects in both groups were equivalently performed the same home exercise program and the obese. The mean level of physical activity also was additional benefit of the clinical intervention was equivalent for those subjects who had served in the allowed to regress over time. It would be interesting to military and for those subjects who had not served in the determine whether additional sessions would further military. The average number of days per week of reduce the need for total joint replacement and other vigorous physical activity at the time of study enrollment also was equivalent for those subjects with prior militaryservice (average days per week⫽2.13, 95% CI⫽1.45– Alternatively, it may be possible for patients or their 2.80) versus those subjects without prior military service spouses to administer simple manual therapy techniques (average days per week⫽2.00, 95% CI⫽1.48 –2.52).
to perpetuate the effects of clinical intervention. How- Finally, most of the subjects who had served in the ever, patients with knee OA may be elderly and have military had been retired for periods of time longer than involvement in other joints, which may make it difficult the duration of their military service.
for self-treatment or even treatment administered by aspouse. Future studies, we believe, should address One rationale for the manual therapy approach to OA is whether patients with OA of the knee might be catego- that the reduced pain and stiffness associated with the rized into specific subgroups with preferentially greater manual therapy intervention allows patients to partici- probabilities of responding to specific interventions.
pate more successfully in the exercise program andactivities of daily living. Knee OA symptoms may result Two potential threats to internal validity in the current from restricted mobility and adhesions due to recurrent study warrant consideration. It is possible that both inflammations of both intra-articular and periarticular groups improved for reasons unrelated to our interven- tissues. Movement restrictions due to changes within tion. The clinical treatment group may have improved these tissues also may alter the biomechanical forces on more dramatically simply because of the increased inten- articular surfaces to create additional symptoms. The sity of the relationship with the physical therapists. We manual therapy passive movement techniques were consider this explanation unlikely for 2 reasons. First, applied to increase excursion in both intra-articular and both groups comprised patients with chronic OA; the periarticular tissues when restricted mobility was judged average duration of symptoms was more than 5 years. It to be related to the reproduction of symptoms or is unlikely in these groups that spontaneous improve- ments of 35% to 50% would be observed over a 1-monthperiod. Second, the current study builds on the results of an earlier study 48 with a placebo group. In that study, no A clinical physical therapy program of manual therapy to changes in the WOMAC scale or in 6-minute walk test the lower quarter combined with supervised exercise distances were observed in the placebo group from applied by skilled physical therapists was compared with initiation of treatment through the 1-year follow-up. The a home exercise program for improving function and placebo group in the earlier study had the same intensity decreasing stiffness and pain in subjects with OA of the of physical therapist interaction as the clinical interven- knee. The comprehensive clinical treatment program 1314 . Deyle et al Physical Therapy . Volume 85 . Number 12 . December 2005 resulted in large improvements, reproducing the results 15 Jevsevar DS, Riley PO, Hodge WA, Krebs DE. Knee kinematics and
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Physical Therapy . Volume 85 . Number 12 . Deyle et al . 1317 Physical Therapy Treatment Effectiveness for
Osteoarthritis of the Knee: A Randomized
Comparison of Supervised Clinical Exercise and
Manual Therapy Procedures Versus a Home
Program
Gail D Deyle, Stephen C Allison, Robert L Matekel,
Michael G Ryder, John M Stang, David D Gohdes,
Jeremy P Hutton, Nancy E Henderson and Matthew B
Garber
PHYS THER. 2005; 85:1301-1317.
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