scholarly journals Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT

2021 ◽  
Vol 25 (48) ◽  
pp. 1-158
Author(s):  
Sally Hopewell ◽  
David J Keene ◽  
Peter Heine ◽  
Ioana R Marian ◽  
Melina Dritsaki ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Confidence Interval ◽  
Shoulder Pain ◽  
Best Practice ◽  
Exercise Intervention ◽  
Corticosteroid Injection ◽  
Mean Difference ◽  
Progressive Exercise ◽  
And Function

Background Rotator cuff-related shoulder pain is very common, but there is uncertainty regarding which modes of exercise delivery are optimal and the long-term benefits of corticosteroid injections. Objectives To assess the clinical effectiveness and cost-effectiveness of progressive exercise compared with best-practice physiotherapy advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. Design This was a pragmatic multicentre superiority randomised controlled trial (with a 2 × 2 factorial design). Setting Twenty NHS primary care-based musculoskeletal and related physiotherapy services. Participants Adults aged ≥ 18 years with a new episode of rotator cuff-related shoulder pain in the previous 6 months. Interventions A total of 708 participants were randomised (March 2017–May 2019) by a centralised computer-generated 1 : 1 : 1 : 1 allocation ratio to one of four interventions: (1) progressive exercise (n = 174) (six or fewer physiotherapy sessions), (2) best-practice advice (n = 174) (one physiotherapy session), (3) corticosteroid injection then progressive exercise (n = 182) (six or fewer physiotherapy sessions) or (4) corticosteroid injection then best-practice advice (n = 178) (one physiotherapy session). Main outcome measures The primary outcome was Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes included SPADI subdomains, the EuroQol 5 Dimensions, five-level version, sleep disturbance, fear avoidance, pain self-efficacy, return to activity, Global Impression of Treatment and health resource use. Outcomes were collected by postal questionnaires at 8 weeks and at 6 and 12 months. A within-trial economic evaluation was also conducted. The primary analysis was intention to treat. Results Participants had a mean age of 55.5 (standard deviation 13.1) years and 49.3% were female. The mean baseline SPADI score was 54.1 (standard deviation 18.5). Follow-up rates were 91% at 8 weeks and 87% at 6 and 12 months. There was an overall improvement in SPADI score from baseline in each group over time. Over 12 months, there was no evidence of a difference in the SPADI scores between the progressive exercise intervention and the best-practice advice intervention in shoulder pain and function (adjusted mean difference between groups over 12 months –0.66, 99% confidence interval –4.52 to 3.20). There was also no difference in SPADI scores between the progressive exercise intervention and best-practice advice intervention when analysed at the 8-week and 6- and 12-month time points. Injection resulted in improvement in shoulder pain and function at 8 weeks compared with no injection (adjusted mean difference –5.64, 99% confidence interval –9.93 to –1.35), but not when analysed over 12 months (adjusted mean difference –1.11, 99% confidence interval –4.47 to 2.26), or at 6 and 12 months. There were no serious adverse events. In the base-case analysis, adding injection to best-practice advice gained 0.021 quality-adjusted life-years (p = 0.184) and increased the cost by £10 per participant (p = 0.747). Progressive exercise alone was £52 (p = 0.247) more expensive per participant than best-practice advice, and gained 0.019 QALYs (p = 0.220). At a ceiling ratio of £20,000 per quality-adjusted life-year, injection plus best-practice advice had a 54.93% probability of being the most cost-effective treatment. Limitations Participants and physiotherapists were not blinded to group allocation. Twelve-month follow-up may be insufficient for identifying all safety concerns. Conclusions Progressive exercise was not superior to a best-practice advice session with a physiotherapist. Subacromial corticosteroid injection improved shoulder pain and function, but provided only modest short-term benefit. Best-practice advice in combination with corticosteroid injection was expected to be most cost-effective, although there was substantial uncertainty. Future work Longer-term follow-up, including any serious adverse effects of corticosteroid injection. Trial registration Current Controlled Trials ISRCTN16539266 and EudraCT 2016-002991-28. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 48. See the NIHR Journals Library website for further project information.

scholarly journals Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ioana R. Marian ◽  
Sally Hopewell ◽  
David J. Keene ◽  
Lucy Cureton ◽  
Sarah E. Lamb ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Shoulder Pain ◽  
Best Practice ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Progressive Exercise ◽  
Randomised Controlled

Abstract Background The Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. This article describes the statistical analysis plan for the GRASP randomised controlled trial. Methods/design GRASP is a multicentre randomised controlled trial using a 2 × 2 factorial design. Adults aged ≥ 18 years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery, are randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection then best practice advice. The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score over 12 months. Secondary outcomes are as follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability. Here, we describe in detail the following: sample size calculation, descriptive statistics of the primary and secondary outcomes, statistical models used for the analysis of the main outcomes, handling of missing data, planned sensitivity and subgroup analyses. This pre-specified statistical analysis plan was written and submitted without prior knowledge of the trial results. Discussion Publication of the statistical analysis plan for the GRASP trial aims to reduce the risk of outcome reporting bias and increase transparency of the data analysis. Any deviations or changes to the current SAP will be described and justified in the final study report and any results publications. Trial registration International Standard Randomised Controlled Trial Number ISRCTN16539266. Registered on 14 June 2016. EudraCT number 2016-002991-28. Registered on 12 June 2016.

Shockwave therapy associated with progressive exercises in rotator cuff tendinopathy: a clinical trial protocol

2021 ◽  
Author(s):  
Athilas Braga de Menezes ◽  
Rodrigo Scattone Silva ◽  
Juliana Franco Adala ◽  
Renata Michelini Guidi ◽  
Richard Eloin Liebano
Keyword(s):  
Rotator Cuff ◽  
Shoulder Pain ◽  
Rating Scale ◽  
Exercise Program ◽  
Score Function ◽  
Shockwave Therapy ◽  
Patient Reported ◽  
Progressive Exercise ◽  
And Function ◽  
Rotator Cuff Tendinopathy

The aim of the present study is to determine whether adding shockwave therapy (SWT) to a progressive exercise program improves shoulder pain and function in individuals with rotator cuff tendinopathy (RC tendinopathy). Ninety patients diagnosed with rotator cuff tendinopathy will be randomly allocated into two groups: active SWT plus a progressive exercise program or placebo SWT plus a progressive exercise program. Primary outcomes will be measured using the Constant–Murley Score function questionnaire and by assessing patient-reported pain intensity with the numerical pain rating scale. The secondary outcomes will be measured using the Global Perceived Effects Scale and Shoulder Pain and Disability Index. All the outcomes will be measured immediately after the end of treatment and at 3-month follow-up.

Effects of electromyographic biofeedback interventions for shoulder pain and function: Systematic review and meta-analysis

2021 ◽  
pp. 026921552199095
Author(s):  
Danilo Harudy Kamonseki ◽  
Letícia Bojikian Calixtre ◽  
Rodrigo Py Gonçalves Barreto ◽  
Paula Rezende Camargo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Shoulder Pain ◽  
Meta Analysis ◽  
Quality Of Evidence ◽  
Electromyographic Biofeedback ◽  
Mean Differences ◽  
And Function

Objective: To systematically review the effectiveness of electromyographic biofeedback interventions to improve pain and function of patients with shoulder pain. Design: Systematic review of controlled clinical trials. Literature search: Databases (Medline, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and SCOPUS) were searched in December 2020. Study selection criteria: Randomized clinical trials that investigated the effects of electromyographic biofeedback for individuals with shoulder pain. Patient-reported pain and functional outcomes were collected and synthesized. Data synthesis: The level of evidence was synthesized using GRADE and Standardized Mean Differences and 95% confidence interval were calculated using a random-effects inverse variance model for meta-analysis. Results: Five studies were included with a total sample of 272 individuals with shoulder pain. Very-low quality of evidence indicated that electromyographic biofeedback was not superior to control for reducing shoulder pain (standardized mean differences = −0.21, 95% confidence interval: −0.67 to 0.24, P = 0.36). Very-low quality of evidence indicated that electromyographic biofeedback interventions were not superior to control for improving shoulder function (standardized mean differences = −0.11, 95% confidence interval: −0.41 to 0.19, P = 0.48). Conclusion: Electromyographic biofeedback may be not effective for improving shoulder pain and function. However, the limited number of included studies and very low quality of evidence does not support a definitive recommendation about the effectiveness of electromyographic biofeedback to treat individuals with shoulder pain.

scholarly journals Relative Efficacy of Three of Nonsurgical Treatments for Calcific Tendinitis: Physical Therapy vs Steroid Injection vs Ultrasound-Guided Aspiration

2021 ◽  
Vol 9 (7_suppl4) ◽  
pp. 2325967121S0021
Author(s):  
Mauricio Drummond ◽  
Caroline Ayinon ◽  
Albert Lin ◽  
Robin Dunn
Keyword(s):  
Physical Therapy ◽  
Rotator Cuff ◽  
Conservative Treatment ◽  
Conservative Management ◽  
Surgical Intervention ◽  
Corticosteroid Injection ◽  
Calcific Tendinitis ◽  
Ultrasound Guided ◽  
Calcium Deposits

Objectives: Calcific tendinitis of the shoulder is a painful condition characterized by the presence of calcium deposits within the tendons of the rotator cuff (RTC) that accounts for up to 7% of cases of shoulder pain1. The most common conservative treatments typically include physical therapy (PT), corticosteroid injection (CSI), or ultrasound-guided aspiration (USA). When conservative management fails, the patient may require arthroscopic surgery to remove the calcium with concomitant rotator cuff repair. The purpose of this study was to characterize the failure rates, defined as the need for surgery, of each of these three methods of conservative treatment, as well as to compare post-operative improvement in patient-reported outcomes (PROs) – including subjective shoulder values (SSV) and visual analog scale (VAS) pain scores – based on the type of pre-operative conservative intervention provided. A secondary aim was to compare post-operative range of motion (ROM) outcomes between groups that failed conservative management. We hypothesized that all preoperative conservative treatments would have equivalent success rates, PROs, and ROM. Bosworth B. Calcium deposits in the shoulder and subacromial bursitis: a survey of 12122 shoulders. JAMA. 1941;116(22):2477-2489. Methods: A retrospective review of all patients who were diagnosed with calcific tendinitis at our institution treated among 3 fellowship trained orthopedic surgeons between 2009 and 2019 was performed. VAS, SSV, and ROM in forward flexion (FF) and external rotation (ER) was abstracted from the medical records. Scores were recorded at the initial presentation as well as final post-operative follow-up visit for those who underwent surgery. The conservative treatment method utilized by each patient was recorded and included PT, CSI, or USA. Failure of conservative management was defined as eventual progression to surgical intervention. Statistical analysis included chi-square, independent t test and ANOVA. Descriptive statistics were used to report data. A p<0.05 was considered to be statistically significant. Results: 239 patients diagnosed with calcific tendinitis were identified in the study period with mean age of 54 years and follow up of at least 6 months. In all, 206 (86.2%) patients underwent a method of conservative treatment. Of these patients, 71/239 (29.7%) underwent PT, 67/239 (28%) attempted CSI, and 68/239 (28.5%) underwent USA. The overall failure rate across all treatment groups was 29.1%, with injections yielding the highest success rate of 54/67 (80.6%). Physical therapy saw the highest failure rate, with 26/71 (36.7%) proceeding to surgical intervention. Patients undergoing physical therapy were statistically more likely to require surgery compared to those undergoing corticosteroid injection (RR 1.88, p= 0.024). Of all 93 patients who underwent surgery, VAS, SSV, ROM improved significantly in all groups. On average, VAS decreased by 4.02 points (6.3 to 2.3), SSV increased by 33 points (51 to 84), FF improved by 13.8º, and ER improved 8.4º between the pre- and post-operative visits (p<0.05). The 33 patients who did not attempt a conservative pre-operative treatment demonstrated the largest post-operative improvement in VAS (-6.00), which was significantly greater than those who previously attempted PT (-3.33, p<0.05). There was a trend towards greater improvement in SSV in the pre-operative PT group (45 to 81) compared to others, but this did not reach statistical significance (p=0.47). Range of motion was not significantly affected by the method of pre-operative conservative intervention. Conclusions: Conservative treatment in the form of physical therapy, corticosteroid injection, and ultrasound-guided aspiration is largely successful in managing calcific tendinitis of the shoulder. Of these, PT demonstrated the highest rate of failure in terms of requiring surgical management. PRO improvement varied among the conservative modalities used, however patients who did not attempt conservative management experienced the greatest improvements following surgery. If surgery is necessary following failed conservative treatment, excellent outcomes can be expected with significant improvements in ROM and PROs. This information should be considered by the surgeon when deciding whether to recommend conservative treatment for the management of calcific tendinitis, as well as which specific method to employ.

Platelet-Rich Plasma versus Corticosteroid Injections in Rotator Cuff Related Shoulder Pain: A Comparative Study with Up to 18 Months of Follow-Up

2021 ◽  
Author(s):  
Juho Annaniemi ◽  
Jüri Pere ◽  
Salvatore Giordano
Keyword(s):  
Rotator Cuff ◽  
Shoulder Pain ◽  
Platelet Rich Plasma ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Subacromial Injection ◽  
Western Ontario Rotator Cuff ◽  
Feasible Alternative ◽  
Cuff Repair

Abstract Purpose: Given the complications involved in corticosteroid (CS) injections, subacromial platelet-rich plasma (PRP) injections may provide a valid alternative to CS in the treatment of rotator cuff related shoulder pain (RCRSP).Methods: We retrospectively reviewed a total of 98 patients affected by RCRSP who were treated with either subacromial injection of PRP or CS. The PRP group received three injections of autologous PRP at two weeks interval, and the CS group received one injection of CS. Western Ontario Rotator Cuff Index (WORC) was the primary outcome measure, while secondary outcome measures were the Visual Analogue Scale (VAS), Range of Motion (ROM) and need for cuff repair surgery, which were analyzed at interval of 6, 12, and 18 months.Results: A total of 75 patients were included in the analysis (PRP n = 35, CS n = 40). Mean follow-up was (PRP 21.1 ± 8.7 months vs CS 33.6 ± 16.3 months, p <0.001). Both groups showed improvement in WORC, VAS and ROM. No significant differences were detected between the two groups in any of the primary (WORC) or secondary outcomes during 6, 12 and 18 months (all p > 0.05). No adverse events were detected.Conclusion: Both treatments improve RCRSP patient’s symptoms, but none of them seems to result in a significant better outcome in this series of patients. PRP can be a safe and feasible alternative to CS in treatment of RCRSP even at long follow-up, to reduce local and systemic effects involved with CS injections.

Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) When Combined With Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial

2017 ◽  
Vol 45 (11) ◽  
pp. 2547-2554 ◽  
Author(s):  
Elisabeth Kvalvaag ◽  
Jens Ivar Brox ◽  
Kaia Beck Engebretsen ◽  
Helene Lundgaard Soberg ◽  
Niels Gunnar Juel ◽  
...  
Keyword(s):  
Shock Wave ◽  
Rotator Cuff ◽  
Shoulder Pain ◽  
Controlled Trial ◽  
Extracorporeal Shock Wave Therapy ◽  
Mean Difference ◽  
Shock Wave Therapy ◽  
Level Of Evidence ◽  
Group Assignment ◽  
Extracorporeal Shock Wave

Background: Subacromial shoulder pain is a common complaint, and radial extracorporeal shock wave therapy (rESWT) is increasingly used to treat this condition. Although many therapists use rESWT in combination with supervised exercises, no studies have evaluated the additional effect of rESWT with supervised exercises for subacromial shoulder pain. Purpose: To assess whether rESWT is more effective than sham rESWT when combined with supervised exercises for improving pain and function in patients with subacromial shoulder pain. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between 25 and 70 years of age with subacromial shoulder pain with and without calcification in the rotator cuff lasting at least 3 months were assessed for eligibility; 143 patients were recruited. Participants were allocated (1:1) by computer-generated randomization in blocks of 20 to receive either rESWT or sham rESWT in addition to supervised exercises. The rESWT and sham rESWT were performed once a week with additional supervised exercises once a week for the first 4 weeks. The following 8 weeks, the patients received supervised exercises twice a week. The primary outcome was change in the Shoulder Pain and Disability Index (SPADI) after 24 weeks. Patients and outcome assessors were masked to group assignment. Results: At 24 weeks, participants in both the sham group and the rESWT group had improved ( P < .001) in SPADI score compared with baseline (−23.9 points [SD, 23.8 points] and −23.3 points [SD, 25.0 points], respectively), but there were no differences between the groups (mean difference 0.7; 95% CI, −6.9 to 8.3; P = .76). Prespecified subgroup analysis of patients with calcification in rotator cuff showed that the rESWT group had a greater improvement in SPADI score after 24 weeks (mean difference −12.8; 95% CI, −24.8 to −0.8; P = .018). Conclusion: Radial ESWT offered no additional benefit to supervised exercises in the treatment of subacromial shoulder pain after 24 weeks, except in the subgroup of patients with calcification in the rotator cuff. Registration: NCT01441830 ( ClinicalTrials.gov identifier).

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