Heavy shoulder strengthening exercise in people with hypermobility spectrum disorder (HSD) and long-lasting shoulder symptoms: a feasibility study.
ABSTRACT: 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. Conclusions:The shoulder strengthening exercise programme was feasible and safe for people with HSD and long-lasting shoulder symptoms. A future RCT, with an improved recruitment strategy, will demonstrate whether the exercise programme is also effective in improving symptoms and muscle-tendon function in this population. Trial registration:ClinicalTrials.gov: NCT03547570. Registered on May 3, 2018.
Project description:<b>Background: </b>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.<br><br><b>Methods: </b>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.<br><br><b>Discussion: </b>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.<br><br><b>Trial registration: </b>ClinicalTrials.gov NCT03869307 . Registered on 11 March 2019.
Project description:Background:There is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs). Purpose/Hypothesis:The purpose of this study was to assess the efficacy and safety of physical therapist-supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX. Study Design:Randomized controlled trial; Level of evidence, 2. Methods:A total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events. Results:The between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (-228.1 [95% CI, -430.5 to -25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported. Conclusion:Neuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed. Registration:NCT02371928 (ClinicalTrials.gov identifier).
Project description:BACKGROUND:Patients with non-operated traumatic primary anterior shoulder dislocation (PASD) are assumed to have less shoulder impairment than patients with recurrent anterior shoulder dislocations (RASD). This may impact treatment decision strategy. The aim was to study whether patients with non-operated traumatic PASD have less shoulder impairment than those with RASD. METHODS:In a cross-sectional study baseline data from patients with PASD and RASD in a randomised controlled trial of non-operative shoulder exercise treatment were used. Shoulder function was self-reported (Western Ontario Shoulder Instability (WOSI), Tampa Scale of Kinesiophobia (TSK), General Health (EQ-5D-VAS), Numeric Pain Rating Scale (NPRS)), and measured (Constant-Murley shoulder Score (CMS total), CMS - Range of Motion (CMS-ROM, CMS - strength, proprioception, clinical tests). RESULTS:In total, 56 patients (34 (28 men) with PASD and 22 (21 men) with RASD) (mean age 26?years) participated. WOSI total was 1064 and 1048, and TSK above 37 (indicating high re-injury fear) was present in 33 (97%) and 21 (96%) of the groups with PASD and RASD, with no group difference. CMS total (66.4 and 70.4), CMS-ROM (28.7 and 31.5), CMS-strength (injured shoulder: 7.6?kg and 9.1?kg), proprioception and clinical tests were the same. Furthermore, 26 (76%) with PASD and 13 (59%) with RASD reported not to have received non-operative shoulder treatment. CONCLUSIONS:Non-operated patients with PASD and self-reported shoulder trouble three-six weeks after initial injury do not have less shoulder impairment (self-reportedly or objectively measured) than non-operated patients RASD and self-reported shoulder trouble three-six weeks after their latest shoulder dislocation event.
Project description:To translate and adapt the Western Ontario Shoulder Instability (WOSI) questionnaire into Danish and, to evaluate measurement properties of an electronic Danish WOSI version.The Swedish WOSI version was used for translation and adaptation into Danish followed by examination of test-retest reproducibility (14-day interval) besides concurrent and construct validity. Concurrent validity was examined by comparing WOSI in paper version with an electronic version, whereas construct validity was examined by comparing WOSI with Numeric Pain Rating Scale (NPRS) and the Oxford Shoulder Score (OSS). Reproducibility was evaluated with Intraclass correlations (ICC), Standard Error of Measurement (SEM), minimal detectable change (MDC) and limits of agreement (LOA). Validity was evaluated with Pearson's (r) and Concordance Correlation Coefficients (CCC).41 subjects (median age 34, range 18-57) were included in the analysis of reproducibility. An ICC of 0.97 (95% CI 0.95 to 0.99) for the total WOSI score was found. SEM was 100.1, resulting in an MDC of 277.5 and LOAs within the range of -246.4 and 308.6. 25 subjects (median age 34, range 18-72) were included in the analysis of concurrent validity obtaining a CCC of 0.96 (95% CI 0.91 to 0.98). Construct validity was investigated in 62 subjects (median age 31, range 18-72) obtaining correlations of 0.83 (95% CI 0.68 to 0.97) (NPRS) and 0.79 (95% CI 0.62 to 0.94) (OSS).An electronic Danish version of WOSI presented excellent test-retest reproducibility and acceptable measurement errors. Also, concurrent validity between paper and electronic version was highly satisfactory as was the construct validity. Surprisingly, though, the NPRS correlated more with WOSI than OSS.
Project description:INTRODUCTION:Lifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this investigation is to compare the short, mid and long-term effects, in terms of symptoms, functional limitations, kinesiophobia and pain catastrophising, of three different shoulder rehabilitation approaches (education, strengthening, motor control) in adults with RCRSP. METHODS AND ANALYSIS:In this single-blind (assessor), parallel-group, randomised clinical trial, 123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme. They will be randomly assigned to one of three groups (education only, strengthening approach or motor control-focused approach). Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral distances and tendon thickness will be assessed at baseline and 12 weeks. Intervention groups will be compared on outcomes with intention-to-treat analyses using two-way repeated measures analysis of variance if the data are normally distributed or non-parametric analysis of longitudinal data if they are not. ETHICS AND DISSEMINATION:Ethics approval was obtained from the Sectorial Rehabilitation and Social Integration Research Ethics Committee of the Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale (CIUSSS-CN). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER:NCT03892603; pre-results.
Project description:BACKGROUND:The Western Ontario Shoulder Instability index (WOSI) is a questionnaire designed to measure health-related quality of life in patients with shoulder instability. The aim of the current study was to translate the WOSI into Hebrew and assess its psychometric properties. METHODS:The WOSI was translated into Hebrew according to World Health Organization guidelines. Twenty-five patients completed the WOSI and the Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire 2 weeks and 2 months after surgical shoulder stabilization. Internal consistency (Cronbach's α), criterion validity (Pearson's correlation coefficient with DASH), responsiveness, and floor and ceiling effects were assessed. RESULTS:Cronbach's α was 0.88-0.95 for total WOSI (range 0.68-0.95 for different sections). Strong correlation with DASH score (r = 0.76-0.84) indicated good criterion validity. Changes between baseline and follow-up for WOSI and DASH scores were moderately correlated (r = 0.68), suggesting moderate responsiveness. Some items demonstrated floor and ceiling effects, especially at baseline, but no floor or ceiling effects were observed for total WOSI or for the WOSI sections. CONCLUSIONS:The results of the current study demonstrate that the Hebrew version of the WOSI is a valid instrument that can be used to assess disability in patients with shoulder instability. Additional studies are warranted to assess its psychometric properties among various subpopulations. TRIAL REGISTRATION:The study was pre-registered at the ClinicalTrials.gov website, registration number NCT02978365 .
Project description:Background:An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery. Methods:A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. A total of seven participants underwent the SINEX program, a 12-week exercise program including physiotherapist-supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score-Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires including Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE). Results:With one participant recruited every 2 weeks, the recruitment rate was 50% lower than expected. Two of seven participants achieved compliance, defined as at least 66% completion of the scheduled home exercises and at least 50% attendance for the physiotherapist supervised sessions. Barriers for successful compliance were (1) inability to take along exercise equipment when travelling, (2) sick leave, (3) holidays and (4) lack of time/busy days. Four adverse events occurred, one of which was related to the intervention (patellar redislocation). All participants expressed satisfaction with the intervention and felt safe during the exercises. All participants improved in the GPE. Change greater than minimal detectable change (MDC) was reported in four participants in some of the outcome assessments. One of the seven participants declined surgery. Conclusion:Further assessment is required on several areas before performing an RCT evaluating the efficacy of the SINEX program for patients with TASI considered eligible for surgery. No adverse events suggest that the program is safe, but patients with general hypermobility may need additional adjustments to prevent adverse events in other areas of the body. Trial registration:ClinicalTrials.gov: NCT04152304, retrospectively registered.
Project description:Anterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with little to no post-traumatic rehabilitation. This may be due to lack of evidence-based exercise programmes. In similar, high-impact injuries (e.g. anterior cruciate ligament tears in the knee) neuromuscular exercise has shown large success in improving physical function and QoL. Thus, the objective of this trial is to compare a nonoperative neuromuscular exercise shoulder programme with standard care in patients with traumatic anterior shoulder dislocations (TASD).Randomised, assessor-blinded, controlled, multicentre trial. Eighty patients with a TASD will be recruited from three orthopaedic departments in Denmark. Patients with primary or recurrent anterior shoulder dislocations due to at least one traumatic event will be randomised to 12 weeks of either a standardised, individualised or physiotherapist-supervised neuromuscular shoulder exercise programme or standard care (self-managed shoulder exercise programme). Patients will be stratified according to injury status (primary or recurrent). Primary outcome will be change from baseline to 12 weeks in the patient-reported QoL outcome questionnaire, the Western Ontario Shoulder Instability Index (WOSI).This trial will be the first study to compare the efficacy and safety of two different nonoperative exercise treatment strategies for patients with TASD. Moreover, this is also the first study to investigate nonoperative treatment effects in patients with recurrent shoulder dislocations. Lastly, this study will add knowledge to the shared decision-making process of treatment strategies for clinical practice.ClinicalTrials.gov, identifier: NCT02371928 . Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.
Project description:BACKGROUND:Pathological muscle activation patterns of the external rotators and periscapular muscles can result in posterior positional functional shoulder instability (PP-FSI). In several patients, physical therapy and surgical treatment are not successful. PURPOSE:The shoulder-pacemaker treatment concept was evaluated prospectively in patients with PP-FSI and previously failed conventional therapy attempt. STUDY DESIGN:Case series; Level of evidence, 4. METHODS:A negative selection of 24 consecutive cases of noncontrollable PP-FSI in 16 patients with previously failed conventional therapy were included in this prospective study. The shoulder-pacemaker treatment consisted of an electrical muscle stimulation-based therapy protocol with 9 to 18 one-hour treatment sessions. Two patients were excluded because of nonadherence to the training schedule, leaving a final study cohort of 21 cases in 14 patients. Follow-up included assessment of clinical function, impairment during daily activities and sports, satisfaction, Western Ontario Shoulder Instability Index (WOSI), Rowe score, and Subjective Shoulder Value at 0 weeks, 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 24 months after intervention. RESULTS:WOSI, Subjective Shoulder Value, and Rowe score showed a highly significant improvement at all time points of follow-up (P < .001). Young age (P = .005), low weight (P = .019), shoulder activity level (P = .003), unilateral affliction (P = .046), and higher baseline WOSI score (P = .04) were associated with a better treatment effect. Cases with increased glenoid retroversion, posterior scapulohumeral decentering, and dysplastic bony glenoid shape showed a trend toward shorter treatment effect duration. No complications during the intervention or follow-up period were observed. CONCLUSION:The shoulder-pacemaker therapy concept is an effective treatment with rapid improvement and sustained outcome over the course of 2 years in patients with noncontrollable PP-FSI with previously failed conventional treatment. Young and more athletic patients with lower weight and unilateral pathology respond best to the treatment.
Project description:The pain experience has multiple influences, but little is known about how specific biological and psychological factors interact to influence pain responses. The current study investigated the combined influences of genetic (pro-inflammatory) and psychological factors on several preclinical shoulder pain phenotypes.An exercise-induced shoulder injury model was used, and a priori selected genetic (IL1B, TNF/LTA region, and IL6 single nucleotide polymorphisms (SNP)) and psychological (anxiety, depression symptoms, pain catastrophizing, fear of pain, and kinesiophobia) factors were included as the predictors of interest. The phenotypes were pain intensity (5-d average and peak reported on numerical rating scale), upper extremity disability (5-d average and peak reported on the Quick Disabilities of the Arm, Shoulder and Hand instrument), and duration of shoulder pain (d).After controlling for age, sex, and race, the genetic and psychological predictors were entered separately as main effects and interaction terms in regression models for each pain phenotype. Results from the recruited cohort (n = 190) indicated strong statistical evidence for the interactions between 1) TNF/LTA SNP rs2229094 and depression symptoms for average pain intensity and duration and 2) IL1B two SNP diplotype and kinesiophobia for average shoulder pain intensity. Moderate statistical evidence for prediction of additional shoulder pain phenotypes included interactions of kinesiophobia, fear of pain, or depressive symptoms with TNF/LTA rs2229094 and IL1B.These findings support the combined predictive ability of specific genetic and psychological factors for shoulder pain phenotypes by revealing novel combinations that may merit further investigation in clinical cohorts to determine their involvement in the transition from acute to chronic pain conditions.