Dataset Information

Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial.

ABSTRACT:

Objective

To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease.

Design

Randomised, participant and single assessor blinded, placebo controlled trial.

Setting

Metropolitan region of Melbourne, Victoria, Australia.

Participants

120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community.

Interventions

The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment.

Main outcome measures

The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants' perceived global rating of overall change.

Results

112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval -2.1 to 9.4) or change in pain (0.7, -0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as "much better"), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, -0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life.

Conclusion

A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists' contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest.

Trial registration

Clinical trials NCT00415441.

SUBMITTER: Bennell K

PROVIDER: S-EPMC2882554 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRotator cuff related pain (RCRP) is one of the most common sources of musculoskeletal shoulder pain affecting the general population. Conservative treatment, in the form of exercise, is considered the first line approach, nonetheless, improvements seem to be modest. One therapeutic modality that might be an adjunct to the treatment of this condition is mobilisation with movement (MWM). MWM is a pain-free manual procedure that targets restricted and painful movements, commonly seen in patients with RCRP. The purpose of clinical trial is to determine whether MWM with exercise has benefits over sham MWM with exercise in RCRP.MethodsA randomised, sham-controlled trial of 70 adults complaining of RCRP will compare the effects of MWM combined with exercise over sham MWM with exercise. Participants will be allocated to one of two groups: exercise and MWM (EG) or exercise and sham MWM (CG). Two weekly individual treatment sessions will be conducted over five weeks. All assessments will be performed by a blinded assessor. Primary outcome measures will be the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS), assessed at baseline, discharge and one-month follow-up. Secondary outcome measures will be active range of motion, self-efficacy and the global rating of change scale. The analyses will be conducted considering a statistically significant p-value ≤0.05. Normality will be assessed with the Kolmogorov-Smirnov test and homogeneity with the Levene's test. For the primary outcome measures (SPADI and NPRS) and self-efficacy, a 2 × 3 ANOVA with treatment group (EG versus CG) and time (baseline, end of the treatment and follow-up) factors will be performed. Separate 2 × 2 ANOVA will be used for range of motion (baseline and end of the treatment). Global rating scale of change analysis will be conducted using descriptive statistics. Intention-to-treat analysis will be adopted.DiscussionAs there is a paucity of longitudinal studies investigating the use of MWM in patients with RCRP, this study will help to better understand its role together with a structured exercise programme.Trial registrationClinical Trials Registry number NCT04175184 . November, 2019.

Project description:Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost-effectiveness.This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor monthly. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Participant measures of perceived change will be compared between groups by calculating the relative risks and their 95% confidence intervals at each time point using log binomial regression.Results from this trial will contribute to the evidence regarding the effectiveness of a physiotherapy program for the management of CRCP.

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