Jump to: Page Content, Site Navigation, Site Search,
You are seeing this message because your web browser does not support basic web standards. Find out more about why this message is appearing and what you can do to make your experience on this site better.
BMJ 2007;335:812 (20 October), doi:10.1136/bmj.39311.460093.BE (published 20 September 2007)
Catherine J Minns Lowe, research fellow1, Karen L Barker, director2, Michael Dewey, special lecturer3, Catherine M Sackley, professor of physiotherapy research1
1 Department of Primary Care and General Practice, University of Birmingham, 2 Physiotherapy Research Unit, Nuffield Orthopaedic Hospital NHS Trust, Oxford, 3 School of Community Health Sciences, University of Nottingham
Correspondence to: C J Minns Lowe, Physiotherapy Research Unit, Nuffield Orthopaedic Centre NHS Trust, Oxford OX3 7LD catherine.minnslowe{at}noc.anglox.nhs.uk
Design Systematic review.
Data sources Database searches: AMED, CINAHL, Embase, King's Fund, Medline, Cochrane library (Cochrane reviews, Cochrane central register of controlled trials, DARE), PEDro, Department of Health national research register. Hand searches: Physiotherapy, Physical Therapy, Journal of Bone and Joint Surgery (Britain) Conference Proceedings.
Review methods Randomised controlled trials were reviewed if they included a physiotherapy exercise intervention compared with usual or standard physiotherapy care, or compared two types of exercise physiotherapy interventions meeting the review criteria, after discharge from hospital after elective primary total knee arthroplasty for osteoarthritis.
Outcome measures Functional activities of daily living, walking, quality of life, muscle strength, and range of motion in the knee joint. Trial quality was extensively evaluated. Narrative synthesis plus meta-analyses with fixed effect models, weighted mean differences, standardised effect sizes, and tests for heterogeneity.
Results Six trials were identified, five of which were suitable for inclusion in meta-analyses. There was a small to moderate standardised effect size (0.33, 95% confidence interval 0.07 to 0.58) in favour of functional exercise for function three to four months postoperatively. There were also small to moderate weighted mean differences of 2.9 (0.61 to 5.2) for range of joint motion and 1.66 (–1 to 4.3) for quality of life in favour of functional exercise three to four months postoperatively. Benefits of treatment were no longer evident at one year.
Conclusions Interventions including physiotherapy functional exercises after discharge result in short term benefit after elective primary total knee arthroplasty. Effect sizes are small to moderate, with no long term benefit.
As it is difficult to locate physiotherapy trials, we considered that using multiple general searches was the optimum method. This review is part of a series that included both knee and hip search terms. Table 1 summarises the searches.
No language restrictions were applied.
|
Validity assessment, data abstraction, and quality assessment
We developed and piloted a data extraction form using quality indicators from the CONSORT statement7 and the CASP guidelines8 (table 2)
. Similar analysis of individual quality components has previously been used in reviews of physiotherapy9 and is advocated to avoid known problems associated with existing composite scores.10 Items could be marked as yes, no, unclear, or partial. Items were marked as yes only if they fully and explicitly met the detailed criteria laid out in the CONSORT standards.7 Two reviewers (CML and KB) independently extracted the data. KB was masked to the key details of each paper and the extent to which masking was successful was assessed. The masking rates were 80% for authors, 20% for journals, 80% for author affiliations, and 80% for funding sources, all of which except journal of publication were considered successful. The level of agreement between reviewers was 69.09% (
0.524, intraclass correlation coefficient (2,1) 0.49, 95% confidence interval 0.30 to 0.63).
|
We considered studies to be of good quality if they were good enough to include in meta-analyses. Table 2 presents quality assessment findings for each study.
We excluded one studyw1 from the meta-analysis because participants were allocated by alternation. All trial outcomes were measured by assessors masked to allocation. As table 2 shows, most studies clearly reported the flow of participants through the trial, justified the sample size, and included intention to treat analyses. Several quality indicators were not fully discussed in all papers, such as allocation concealment and details regarding the implementation of randomisation methods.
Quantitative data synthesis
We carried out meta-analyses for knee function, walking, range of joint motion, and quality of life with R2.3.1 and the rmeta package.11 Our outcome was the score at the chosen time point rather than the change in score as this maximised the number of comparable studies. The time points used were three to four months after surgery and 12 months after surgery. If the same measure was reported we used weighted mean differences, otherwise we used standardised effect sizes (small (0.2), medium (0.5), and large (0.8)12). We used fixed effect models and 95% confidence intervals throughout and performed tests of heterogeneity (
2) at a 5% significance level, though we accept these have low power because few studies were available for meta-analyses. We also calculated I2 to give a measurement of the degree of heterogeneity between the trials in the meta-analysis. Random effects models were not considered as there was no compelling evidence of heterogeneity and estimating the variation between studies is difficult with such low numbers. The differences were calculated so that positive differences indicate that the effect favoured treatment and negative differences that the effect favoured control or usual care. We considered it inappropriate to assess publication bias because of the small number of trials.
|
|
|
|
|
The comparison groups were mainly control groups in which no additional outpatient physiotherapy was organised. Patients were expected to continue with the traditional home exercise programme—namely, isometric strengthening and range of movement exercises plus gait training or re-education provided to all patients during their stay in hospital.
Quantitative data synthesis
Measures of function (five trials)
Five of the studies contained a measure of function.w1-w5 The measures used included the 12 item Oxford knee score,w4 which measures functional ability, including pain, (scores 12-60, low score indicates high function) (Frost et al used one item of this scorew2); the American Knee Society clinical rating score,w1 w3-w4 which measures pain, movement, stability, and functional activity (scores 0-100, high score indicates favourable); the 24 item Western Ontario and McMaster Universities osteoarthritis index (WOMAC),w3 w5 which has domains for pain, stiffness, and function (scored as a percentage by Moffet el alw5 and out of 0-170 for function by Kramer et alw3 (low scores are favourable)); and the Bartlett patellar score,w4 which measures anterior knee pain, quadriceps strength, and function (scores 3-30, high scores are favourable).
Within the individual trials, three found no significant differences between groups.w1-w3 Frost et al found significant differences within groups for the treatment arm, indicating a benefit of treatment.w2 Mockford and Beverland presented no results in their published abstract but supplied summary statistics for their outcomes,w4 allowing us to include their study in the meta-analysis. Moffet et al found significant differences between the two groups, in favour of the intervention, at four and six months after arthroplasty but not at 12 months.w5
Figure 2
shows the three studies with data on functioning at three to four months and 12 months after surgery. Where studies included more than one measure of function we decided to use the Oxford knee and the WOMAC scores as these encompassed all component trials. No trial included both these scores. At three to four months the standardised effect size was 0.33 (95% confidence interval 0.07 to 0.58), which is considered small to moderate.12 At 12 months, with one additional study, the effect size was close to zero at –0.07 and the confidence interval (–0.28 to 0.14) included zero.
|
The results from these trials were mixed. One trial found no significant differences between groups,w3 another found differences approaching significance,w5 and the third trial found significant differences within intervention groups.w2 Figure 3
shows that the intervention had no overall influence on walking at either three or 12 months.
|
Once again, the results were mixed. Codine et al found a significant difference in knee extension between the two groups at 10 days,w1 though, despite randomisation, extension was different in the two groups at baseline. Another study concluded that there was a significant difference in active knee movement in favour of the intervention group but not in the passive range.w4 In the pilot study by Frost et alw2 there was a trend for less loss of range in the functional group than in the traditional exercise group but the study was small and the difference was not significant. Two other studies also found no significant differences.w3 w6
All the studies on range of movement in the knee joint used the same measure (degrees); therefore figure 4
shows the weighted mean differences and confidence intervals. The three month summary shows an increase of 2.9° (0.61° to 5.2°), which is considered small to moderate. At 12 months the effect was smaller, about 1°, and the confidence interval (–1.10° to 3.00°) included zero.
|
One trial found no significant differences between the groups.w3 One other trial has not yet presented statistical analyses for this measure.w4 The final trial found small significant differences in favour of the intervention group for the role-physical dimension of the SF-36 and the physical and mental component scores at six month follow-up but not at 12 month follow-up.w5
Figure 5
presents the studies with data on quality of life. At three to four months the studies used the same measure, the SF-12, and so we have presented weighted mean difference results. At 12 months after surgery, however, not all studies used the same measure and therefore we used standardised effect sizes.
|
Muscle strength
None of the trials included in the review directly measured muscle strength.
Strengths and weaknesses of review procedures
Physiotherapy literature remains a difficult area to search, with numerous bibliographic databases and unindexed journals.13 While we made every attempt to identify studies in any language, other studies might exist. We believe, however, that this review remains the most comprehensive to date.
Trial quality was good overall. Of the five adequately randomised studies included in the meta-analyses, most were sufficiently powered with adequate strategies to conceal allocation and outcome measurements obtained by assessors blinded to treatment allocation.7 Yet, like most physiotherapy trials,14 studies were relatively small, with 554 participants in the five trials included in the meta-analyses and 614 participants included overall in the review.
The most commonly used outcomes were function, predominantly subjective measures of functional ability, and range of joint motion as an objective measure. While range of joint motion is important, its usefulness as an outcome measure of physiotherapy interventions is limited as other factors, such as prosthetic design, preoperative knee motion, and surgical technique, also influence postoperative range of joint motion.15 None of the trials directly measured muscle strength, although one included leg extensor power,w2 instead studies used objective measures like walking.
There were no apparent problems with our data extraction processes. Although many quality checklists and scales exist, there is no accepted ideal score; component approaches are often preferred as the wide variety of scores and weighting systems available mean that the same trial may score as both high quality and low quality depending on which score is used.10 Additionally, many scoring systems downgrade the quality rating of a trial if it is not double blinded. For many physiotherapy trials, such as those in this review, patients and therapists inevitably know the treatment allocation and this is not an indication of low or high trial quality. For these reasons we used a component approach, although we accept this is controversial.
The
2 tests did not indicate major problems with heterogeneity in any of the eight analyses, but these were limited by low power. The I2 results also indicated no observed heterogeneity.16 The number of available studies, and their size, does limit this review and prevents its findings from being conclusive. It is perhaps surprising that so few published trials exist for such a common practice. This may be partially attributable to the general lack of research on rehabilitation in orthopaedic surgery patients after discharge, rather than knee arthroplasty patients as such, as we also found few existing trials investigating exercise and rehabilitation after elective hip arthroplasty.
Clinical implications
Presently, given the reduction in length of hospital stay, compressed inpatient rehabilitation, and the limitations of the available evidence, it seems reasonable to refer patients for a short course of physiotherapy after discharge to provide short term benefit. While range of motion may be limited as an outcome measure of physiotherapy, the small to moderate standardised effect size obtained for function, which favours the intervention, is considered clinically important. This reflects actual improvements in one or more important aspects of function reported by patients after they received the treatment intervention. The type of physiotherapy provided also needs consideration. In the short term physiotherapy exercise interventions with exercises based on functional activities may be more effective after total knee arthroplasty than traditional exercise programmes, which concentrate on isometric muscle exercises and exercises to increase range of motion in the joint.
Future directions
Although there were few studies and they were not large, they are still likely to have detected most worthwhile effects. These tentative findings suggest that further research would be worthwhile to reduce the current level of uncertainty.17
There seemed to be no benefits related to treatment at one year, though the evidence is not conclusive. The content of the intervention could be better designed and further tested. Interventions to date have largely consisted of exercise programmes and gait rehabilitation, mainly targeting impairment and helping patients to recover from the effects of surgery rather than specifically targeting limitations in activity or restrictions in participation. From the wider field of rehabilitation as a whole, however, such task training seems highly relevant. A recent systematic review, which assessed physiotherapy on functional outcome after stroke, found that effective studies contained focused exercise programmes within which the relevant functional tasks were directly trained.18 Research is currently underway to determine whether a brief feasible physiotherapy intervention of this type, supplied after discharge, affects patient's functional ability one year after knee arthroplasty. An investigation into the health economics is also included.
|
Contributors: CJML designed the review, undertook the review searches, screened trials for eligibility, assessed the quality of the trials, assisted with data analysis, and drafted the paper. She is guarantor. KLB supervised the review, assessed the quality of trials, and reviewed the draft paper. MD designed and undertook the meta-analyses for the review and reviewed the draft paper. CMS supervised the review, screened trials for eligibility, and cowrote the paper.
Funding: CJML is funded by a nursing and allied health professional researcher development award from the Department of Health and NHS research and development. CMS is funded by a primary care career scientist award from the Department of Health and NHS research and development.
Competing interests: None declared.
Ethical approval: Oxford local research ethics committee (AQREC No A03.018).
Provenance and peer review: Not commissioned; peer reviewed.
![]()
CiteULike
Complore
Connotea
Del.icio.us
Digg
Reddit
Technorati What's this?
What can you learn from this BMJ paper? Read Leanne Tite's Paper+