Background: People with hypermobility spectrum disorder (HSD) are in great risk of experiencing shoulder symptoms, but evidence for treatment is sparse. Therefore, the objective was to evaluate the feasibility of 16-week shoulder strengthening programme for improving shoulder strength and function in people with HSD and shoulder symptoms for more than 3 months to inform a future randomised controlled trial (RCT). Methods: Twelve participants (11 females, 39.3 ± 13.9 years) with HSD and shoulder instability and/or pain for more than 3 months underwent a 16-week heavy shoulder strengthening exercise programme three times weekly using exercises targeting scapular and rotator cuff muscles. Primary outcomes were pre-defined research progression criteria including recruitment rate (acceptable, 6 participants/month), assessment duration (acceptable: < 120 min), participant retention (acceptable: > 80% complete intervention), training adherence (acceptable: > 75% adhere to > 36 training sessions) and adverse events (acceptable: minor events with no participants discontinuing the study), besides participant and physiotherapist feedback. Secondary treatment outcomes were assessed using the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse), self-reported pain, kinesiophobia and fatigue, isometric shoulder strength, besides clinical tests for instability, hypermobility, laxity, and proprioception. Results: Recruitment rate was 5.6/month, assessment duration (mean ± SD) 105 ± 9 min, retention 100%, adherence 83%, and four participants experienced short-lasting soreness or pain. Participant feedback was positive, and physiotherapists found the intervention relevant and applicable to the population. The WOSI total score showed an improvement by 51% (mean ± SD, points: baseline 1037 ± 215; Follow up 509 ± 365; mean change (95% CI), − 528 (− 738, − 318)), and participants reported reduced pain, kinesiophobia and fatigue. Shoulder strength measurements improved by 28-31% (mean change (95% CI), Nm/kg: scaption 0.51 (0.23, 0.78); internal rotation 1.32 (0.70, 1.95) and external rotation 0.89 (0.37, 1.40)), and clinical tests indicated decreased shoulder laxity/ instability.
ObjectivesTo investigate the short-term effectiveness of high-load versus low-load strengthening exercise on self-reported function in patients with hypermobility spectrum disorder (HSD) and shoulder symptoms.MethodsA superiority, parallel-group, randomised trial (balanced block randomisation, electronic concealment) including adult patients (n=100) from primary care with HSD and shoulder pain and/or shoulder instability ≥3 months. Patients received 16 weeks of shoulder exercises (three sessions/week): HEAVY (n=50, full-range, high-load, supervised twice/week) or LIGHT (n=50, neutral/mid-range, low-load, supervised three times). The primary outcome was the 16-week between-group difference in self-reported function measured with the Western Ontario Shoulder Instability Index (WOSI, scale 0–2100, 0=best, minimal important difference 252 points). Secondary outcomes were self-reported measures including quality of life and clinical tests including shoulder muscle strength and range of motion. An intention-to-treat analysis with multiple imputation was conducted by a blinded biostatistician using linear regression.Results93 of 100 patients (93%) completed the 16-week evaluation. The mean WOSI score between-group difference significantly favoured HEAVY (−174.5 points, 95% CI −341.4 to −7.7, adjusted for age, sex, baseline score, clustering around clinic). The secondary outcomes were inconclusive, but patients in HEAVY were less likely to have a positive shoulder rotation test >180°, and more likely to rate an important improvement in physical symptoms. There were no serious adverse events, but HEAVY was associated with more transient muscle soreness (56% vs 37%) and headaches (40% vs 20%).ConclusionHigh-load shoulder strengthening exercise was statistically superior to low-load strengthening exercise for self-reported function at 16 weeks and may be used in primary care to treat patients with HSD and shoulder pain and/or instability to improve shoulder function in the short term. Further studies are needed to confirm the clinical relevance, and patients should be supported to manage associated minor adverse events.Trial registration numberNCT03869307.
Background Four out of five patients with hypermobility spectrum disorder (HSD) or hypermobile Ehlers-Danlos syndrome (hEDS) experience shoulder complaints including persistent pain and instability. Evidence suggests that patients with HSD/hEDS who experience knee and back complaints improve with exercise-based therapy. However, no study has focused on exercise-based treatment for the shoulder in this patient group. The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability. The primary aim is to investigate the short-term effectiveness of a 16-week progressive heavy shoulder strengthening programme and general advice (HEAVY) compared with low-load training and general advice (LIGHT), on self-reported shoulder symptoms, function, and quality of life. Methods A superiority, parallel group, randomised controlled trial will be conducted with 100 patients from primary care with HSD/hEDS and shoulder complaints (persistent pain and/or instability) for more than 3 months. Participants will be randomised to receive HEAVY (full range of motion, high load) or LIGHT (neutral to midrange of motion, low load) strengthening programme three times weekly with exercises targeting scapular and rotator cuff muscles. HEAVY will be supervised twice weekly, and LIGHT three times during the 16 weeks. The primary outcome will be between-group difference in change from baseline to 16-week follow-up in the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse). Secondary outcomes will include a range of self-reported outcomes covering symptoms, function, and quality of life, besides clinical tests for shoulder strength, laxity/instability, and proprioception. Outcome assessors will be blinded to group allocation. Participants will be kept blind to treatment allocation through minimal information about the intervention content and hypotheses. Primary analyses will be performed by a blinded epidemiologist. Discussion If effective, the current heavy shoulder strengthening programme will challenge the general understanding of prescribing low-load exercise interventions for patients with HSD/hEDS and provide a new treatment strategy. The study will address an important and severe condition using transparent, detailed, and high-quality methods to potentially support a future implementation. Trial registration ClinicalTrials.gov NCT03869307. Registered on 11 March 2019.
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