Hypermobility Spectrum Disorder (HSD) is a recent diagnosis that covers generalised joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations. Current clinical management of this population with shoulder symptoms is based on limited evidence and includes a combination of non-specific physiotherapy modalities and exercise prescription. There is some evidence suggesting that strength training may be valuable for treatment of this patient-group. Therefore, the aim of this study is to evaluate the effectiveness of a heavy shoulder strengthening exercise programme in patients with HSD and shoulder symptoms.
Hypermobility Spectrum Disorder (HSD) is a recent diagnosis that covers generalised joint hypermobility with one or more secondary symptomatic musculoskeletal manifestations such as chronic shoulder pain and shoulder instability. The evidence for treatment is sparse, but current clinical management of this patient-group with persistent shoulder symptoms is a combination of non-specific physiotherapy modalities and exercise prescription. There is some evidence suggesting that strength training may be valuable for treatment of this patient-group. The intervention consisting of heavy shoulder strengthening exercises has recently been tested to be feasible, and since clinical improvements were seen, the intervention is ready to be studied in a randomised controlled trial. Therefore, the aim of this study is to evaluate the effectiveness of a heavy shoulder strengthening exercise programme and general advice as compared to shoulder stability exercises and general advice (current standard care) in patients with HSD and persistent shoulder symptoms. The primary hypothesis is that a heavy shoulder strengthening exercise programme is superior to standard care. Sample size considerations: a clinically significant effect of 252 points or more out of 2100 points (SD = 350 points) between the two groups over the 16 weeks is desired, which with a two-sided significance of 0.05, a power of 0.9, and 16% dropout, requires a total of 100 patients. In case 100 patients are not included within 24 months, a stopping rule will be applied as soon as at least 76 patients are included, corresponding to a power of minimum 0.8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
The exercise programme includes exercises identified in literature to target scapular and rotator cuff muscles.
GPs and physiotherapists
Esbjerg, Region Syddanmark, Denmark
GPs and physiotherapists
Middelfart, Region Syddanmark, Denmark
GPs and physiotherapist
Odense, Region Syddanmark, Denmark
Change in Western Ontario Shoulder Instability Index (WOSI) questionnaire total score
Western Ontario Stability Index questionnaire (WOSI) is a tool designed for self-assessment of shoulder function for patients with instability problems. This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored from 0-2100 points (better to worse). There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300). Subscale scores are added to determine the total score out of a possible 2100 points, with 2100 representing the worst possible score.
Time frame: 16 weeks
Change in pain level on numeric pain rating scale
Assessment of shoulder pain will be measured by the Numerical Rating scale of pain (NPRS) with numbers from 0 - 10 ("no pain" to "extreme pain"). The pain level will be measured at baseline as the intensity of pain right now, and at 16 weeks follow-up, and in addition, the worst, least and average pain level for the past week will be measured one time weekly.
Time frame: 12 months.
Change in symptom level on numeric rating scale
Assessment of shoulder symptoms other than pain (instability, subluxation, looseness) will be measured by the Numerical Rating Scale (NRS) with numbers from 0 - 10 ("no symptoms" to "extreme symptoms"). The symptom level will be measured at baseline as the intensity of symptoms right now, and at 16 weeks follow-up. In addition, the worst, least and average symptoms levels for the latest week will be measured one time weekly.
Time frame: 12 months.
Change in Checklist Individual Strength (CIS), fatigue subscale
Assessment of fatigue by the Checklist Individual Strength (CIS), subscale fatigue will be performed at baseline and at 16-week follow up to report the change in level of fatigue. CIS Subscale fatigue consists of 8 items each scored on a 7-point Likert scale (scores ranging from 8 to 56) with high scores indicating high levels of fatigue Timepoints: baseline, 16 weeks, 12 months
Time frame: 12 months.
Change in Dartmouth Primary Care Cooperative Research Network/World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (COOP/WONCA)
To assess the change in functional health status from baseline to 16 weeks follow-up the COOP/WONCA questionnaire will be used. The questionnaire is a generic health status questionnaire for General Practice patients. The questionnaire consists of six single-item measures; physical fitness, feelings (mental well-being), daily activities, social activities, besides change in health and overall health. The categories chosen are scored from one (good functional status) to five (poor functional status) (scores ranging from 6-30, best to worse) Timepoints: baseline, 16 weeks, 12 months
Time frame: 12 months.
Change in Tampa Scale of Kinesiophobia (TSK-11)
Tampa scale of Kinesiophobia is used to measure impression of change in fear of movement from baseline to 16 weeks follow-up. It consists of an 11-item scale where each question is scored on a 4 point Likert scale, with 1 indicating, "strongly disagree" and 4 indicating, "strongly agree". The total scores range from 11-44, with higher scores representing increased fear of movement.
Time frame: 12 months.
Change in EuroQol 5 dimension 5 level (EQ-5D-5L)
The EQ-5D-5L measures change in health related quality of life and includes the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises five dimensions (mobility, Self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension is rated using a five-level ordinal scale from no problems to extreme problems. It results in a preference based index that range from states worse than death (\<0), to 1 (full health), anchoring dead at 0. A score of one indicates that the participants perceived their health at the best possible state and a score below null that the participants perceived their health worse than death. The EQ VAS measures change in health related quality of life. It includes a visual analogue scale where own health 'today´ is rated on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: 12 months.
Change in isometric shoulder strength
Maximum isometric voluntary contraction (MVC) in shoulder scaption, internal rotation and external rotation using a hand-held dynamometer (IsoForce Dynometer EVO2; Medical Device Solutions AG).
Time frame: 16 weeks.
Change in active and passive shoulder range of motion
Internal rotation and external rotation with shoulder in 90 degrees of abduction is measured using a HALO digital goniometer (Halo Medical Devices, Subiaco, Australia).
Time frame: 16 weeks
Change in shoulder proprioception
Shoulder proprioception is measured in shoulder flexion angles (low and mid) using af HALO digital goniometer.
Time frame: 16 weeks
Change in Patient Specific Functional Scale (PSFS)
Patient Specific Functional Scale (PSFS) is administered verbally and used to evaluate whether a health condition impacts a patient's ability to perform activities that are important to him/her. On the initial assessment, the patient is asked to identify up to three important activities that are unable to do or are having difficulty with as a result of symptoms." The patient then provides a rating for each item, on an 11-point ordinal scale ranging from 0 ("unable to perform activity") to 10 ("able to perform activity at the same level as before the injury or problem"). During reassessments, the patient is prompted to re-rate the same activities. The average of up to 3 specific activity scores is recorded, and the range of possible scores is 0 - 10. Higher scores indicate less impairment.
Time frame: 12 months.
Change in clinical shoulder tests
Joint mobility and laxity parameters are assessed using load and shift, sulcus sign, Gagey, apprehension, relocation, release, Rotés Qúerol shoulder hypermobility test, shoulder flexion hypermobility test, and shoulder rotation hypermobility test, all of which are rated as dichotomous (yes/no).
Time frame: 16 weeks.
Adverse events
Adverse events (AE) and serious adverse events (SAE) will be recorded by a weekly questionnaire and at 16-week and 12-month follow-ups by asking the patients about potential AEs using open-probe questioning to ensure that all AEs are recorded. AEs will be categorized into index shoulder or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments.
Time frame: 12 months.
Change in subscales of the Western Ontario Shoulder Instability Index (WOSI) questionnaire
Western Ontario Stability Index questionnaire (WOSI) is a tool designed for self-assessment of shoulder function for patients with instability problems. This questionnaire has 21 questions, each scored on a scale from 0 to 100, with 0 being the best score (no limitations related to the shoulder) and 100 representing the worst score. Overall, the questionnaire is scored from 0-2100 points (better to worse). There are subscale components reporting on: physical symptoms (questions 1 through 10; maximum score of 1000); sports/recreation/work (questions 11 through 14; maximum score 400); lifestyle (questions 15 through 18; maximum score 400); and emotion (questions 19-21; maximum score 300).
Time frame: 12 months.
Physical Activity
The International Physical Activity Questionnaire (IPAQ) is a patient-reported measure of physical activity on a 12-item scale. The total score will be summed within each physical activity domain to estimate the total time spent in occupational, transport, household, and leisure related physical activity, as well as total time reported sitting per week. The total score ranges from 0 to the highest number of time (hours) that the participants can spent on physical activity. A higher score means higher level of physical activity.
Time frame: Baseline
Global Perceived Effect (GPE)
To measure the patients self-rated impression of improvement at follow-up the GPE will be used related to the WOSI subscales (physical symptoms, sports/recreation/work, lifestyle, and emotions). GPE measures self-rated impression of improvement since baseline assessment on a 7-point scale (1 "worse, an important worsening" to 7 "better, an important improvement)
Time frame: 16 weeks
Compliance with exercise
The number of exercise sessions that the patient completes out of 48 sessions.
Time frame: 16 weeks
Demographic
Age, questions regarding civil status, educational level, employment, disease history and previous treatment.
Time frame: Baseline
Anthropometrics
Body mass index
Time frame: Baseline and 16 weeks
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