Hypermobility Syndrome ShoulderNCT03869307
Shoulder Exercises in Hypermobile Patients With Shoulder Symptoms
A study testing Exercise in people with Hypermobility Syndrome Shoulder and Shoulder Pain Chronic, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypermobility Syndrome Shoulder, Shoulder Pain Chronic, Shoulder Luxation
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Apr 2019to 28 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 - 65
- Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men, or Historical HSD (H-HSD) if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items).
- Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either
- musculoskeletal pain in minimum one shoulder for at least three months
- and/or
- recurrent joint dislocations or joint instability without a reported history of trauma defined as either a) minimum three atraumatic dislocations in same shoulder, b) minimum two atraumatic dislocations in two different joints (minimum one in the shoulder) occurring at different times, or c) medical confirmation of joint instability in minimum two joints (minimum one in the shoulder) not related to trauma.
Who cannot join
- Clinically suspected referred pain from the cervical spine
- Systemic inflammatory rheumatic diseases
- Connective tissue diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes, Ehlers-Danlos Syndromes except hypermobile type)
- Neurological diseases
- Pregnancy or childbirth within the past year or planning to get pregnant during the study period
- Shoulder surgery within the past year
Show all 9Show fewer
- Steroid injection in the affected shoulder within three months
- Inability to speak and understand Danish.
- Unable to comply with protocol
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
GPs and physiotherapists
Esbjerg, Region Syddanmark
GPs and physiotherapists
Middelfart, Region Syddanmark
GPs and physiotherapist
Odense, Region Syddanmark
About this study
Official title: Shoulder Exercises in Patients With Hypermobility Spectrum Disorder and Long-lasting Shoulder Symptoms: A Randomised Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Exercise
- Keywords
- Joint instability, Hypermobility, Shoulder, Strength training
- Medical subject headings
- Shoulder Dislocation, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The exercise programme includes exercises identified in literature to target scapular and rotator cuff muscles.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder strengthening exercises | Experimental | Progressive heavy shoulder strengthening exercises three times weekly and advice on load and pain management. Exercise sessions are supervised twice a week corresponding to 32 supervised exercise sessions during the 16 weeks. Receives: Other: Exercise |
| Shoulder stability exercises | Active comparator | Recommendations of shoulder stability exercises which are to be performed unsupervised (e.g. at home) three times weekly and advice on load and pain management. Three supervised sessions are offered during the 16 weeks, and exercises are primarily performed unsupervised at home. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 16 weeks
Change in shoulder proprioception
Shoulder proprioception is measured in shoulder flexion angles (low and mid) using af HALO digital goniometer.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 16 weeks
Compliance with exercise
The number of exercise sessions that the patient completes out of 48 sessions.
Measured: 16 weeks
Demographic
Age, questions regarding civil status, educational level, employment, disease history and previous treatment.
Measured: Baseline
Anthropometrics
Body mass index
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Apr 2019
- Primary completion28 Feb 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypermobility Syndrome ShoulderStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Municipality, The Danish Rheumatism Association, Region of Southern Denmark, Fund for Research, Quality and Education in Physiotherapy Practice
- Responsible party
- Principal investigator, Behnam Liaghat, University of Southern Denmark
- Investigators
- Behnam Liaghat, MSc, Principal investigator, University of Sotuhern DenmarkBirgit Juul-Kristensen, PhD, Study director, University of Southern DenmarkSøren T Skou, PhD, Study chair, University of Southern Denmark, Næstved-Slagelse-Ringsted HospitalsKaren Søgaard, PhD, Study chair, University of Southern DenmarkJens Søndergaard, MD, PhD, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869307
- Sponsor's protocol ID
- S-20170066-RCT
- Status last verified
- Aug 2022
- First submitted
- 5 Mar 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request after the primary publications have been published.
Publications
Liaghat B, Skou ST, Sondergaard J, Boyle E, Sogaard K, Juul-Kristensen B. A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study. Trials. 2020 Dec 1;21(1):992. doi: 10.1186/s13063-020-04892-0.
PubMed 33261635Liaghat B, Skou ST, Sondergaard J, Boyle E, Sogaard K, Juul-Kristensen B. Short-term effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a randomised controlled trial. Br J Sports Med. 2022 Jun 1;56(22):1269-76. doi: 10.1136/bjsports-2021-105223. Online ahead of print.
PubMed 35649707Liaghat B, Skou ST, Sondergaard J, Boyle E, Sogaard K, Juul-Kristensen B. Clinical Characteristics of 100 Patients With Hypermobility Spectrum Disorders and Shoulder Complaints With or Without Mechanical Symptoms: A Cross-sectional Study. Arch Phys Med Rehabil. 2022 Sep;103(9):1749-1757.e4. doi: 10.1016/j.apmr.2021.12.021. Epub 2022 Jan 21.
PubMed 35065941Christensen T, Juhl CB, Juul-Kristensen B, Skou ST, Sondergaard J, Sogaard K, Liaghat B. Association Between Changes in Shoulder Strength and Self-Reported Shoulder Symptoms in Patients With Hypermobility Following 16-Weeks of High-Load or Low-Load Exercise: A Secondary Analysis of an RCT. Physiother Res Int. 2026 Apr;31(2):e70197. doi: 10.1002/pri.70197.
PubMed 41848184Liaghat B, Juul-Kristensen B, Faber DA, Christensen EO, Sogaard K, Skou ST, Sondergaard J, Juhl CB. One-year effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a secondary analysis from a randomised controlled trial. Br J Sports Med. 2024 Mar 21;58(7):373-381. doi: 10.1136/bjsports-2023-107563.
PubMed 38253436
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Exercises in Patients With Hypermobility Spectrum Disorder and Long-lasting Shoulder Symptoms: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03869307
- Acronym / sponsor ID
- S-20170066-RCT
- Keywords
- Joint instability, Hypermobility, Shoulder, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Esbjerg Municipality, The Danish Rheumatism Association, Region of Southern Denmark, Fund for Research, Quality and Education in Physiotherapy Practice
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder strengthening exercises | Experimental | Other: ExerciseProgressive heavy shoulder strengthening exercises three times weekly and advice on load and pain management. Exercise sessions are supervised twice a week corresponding to 32 supervised exercise sessions during the 16 weeks. |
| Shoulder stability exercises | Active comparator | Other: ExerciseRecommendations of shoulder stability exercises which are to be performed unsupervised (e.g. at home) three times weekly and advice on load and pain management. Three supervised sessions are offered during the 16 weeks, and exercises are primarily performed unsupervised at home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 - 65
- Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men, or Historical HSD (H-HSD) if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items).
- Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either
- and/or
Key exclusion criteria (9 listed)
- Clinically suspected referred pain from the cervical spine
- Systemic inflammatory rheumatic diseases
- Connective tissue diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes, Ehlers-Danlos Syndromes except hypermobile type)
- Neurological diseases
- Pregnancy or childbirth within the past year or planning to get pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe exercise programme includes exercises identified in literature to target scapular and rotator cuff muscles. | Other | Shoulder stability exercises, Shoulder strengthening exercises |
Primary outcome
Change in Western Ontario Shoulder Instability Index (WOSI) questionnaire total score
Time frame: 16 weeks
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.
18 secondary outcomes
Change in pain level on numeric pain rating scale
Time frame: 12 months.
Change in symptom level on numeric rating scale
Time frame: 12 months.
Change in Checklist Individual Strength (CIS), fatigue subscale
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)
Time frame: 12 months.
Change in Tampa Scale of Kinesiophobia (TSK-11)
Time frame: 12 months.
Change in EuroQol 5 dimension 5 level (EQ-5D-5L)
Time frame: 12 months.
Change in isometric shoulder strength
Time frame: 16 weeks.
Change in active and passive shoulder range of motion
Time frame: 16 weeks
Change in shoulder proprioception
Time frame: 16 weeks
Change in Patient Specific Functional Scale (PSFS)
Time frame: 12 months.
Change in clinical shoulder tests
Time frame: 16 weeks.
Adverse events
Time frame: 12 months.
Change in subscales of the Western Ontario Shoulder Instability Index (WOSI) questionnaire
Time frame: 12 months.
Physical Activity
Time frame: Baseline
Global Perceived Effect (GPE)
Time frame: 16 weeks
Compliance with exercise
Time frame: 16 weeks
Demographic
Time frame: Baseline
Anthropometrics
Time frame: Baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 33261635Liaghat B, Skou ST, Sondergaard J, Boyle E, Sogaard K, Juul-Kristensen B. A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study. Trials. 2020 Dec 1;21(1):992. doi: 10.1186/s13063-020-04892-0.
- Results publication: PubMed 35649707Liaghat B, Skou ST, Sondergaard J, Boyle E, Sogaard K, Juul-Kristensen B. Short-term effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a randomised controlled trial. Br J Sports Med. 2022 Jun 1;56(22):1269-76. doi: 10.1136/bjsports-2021-105223. Online ahead of print.
- Results publication: PubMed 35065941Liaghat B, Skou ST, Sondergaard J, Boyle E, Sogaard K, Juul-Kristensen B. Clinical Characteristics of 100 Patients With Hypermobility Spectrum Disorders and Shoulder Complaints With or Without Mechanical Symptoms: A Cross-sectional Study. Arch Phys Med Rehabil. 2022 Sep;103(9):1749-1757.e4. doi: 10.1016/j.apmr.2021.12.021. Epub 2022 Jan 21.
- Derived from this study: PubMed 41848184Christensen T, Juhl CB, Juul-Kristensen B, Skou ST, Sondergaard J, Sogaard K, Liaghat B. Association Between Changes in Shoulder Strength and Self-Reported Shoulder Symptoms in Patients With Hypermobility Following 16-Weeks of High-Load or Low-Load Exercise: A Secondary Analysis of an RCT. Physiother Res Int. 2026 Apr;31(2):e70197. doi: 10.1002/pri.70197.
- Derived from this study: PubMed 38253436Liaghat B, Juul-Kristensen B, Faber DA, Christensen EO, Sogaard K, Skou ST, Sondergaard J, Juhl CB. One-year effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a secondary analysis from a randomised controlled trial. Br J Sports Med. 2024 Mar 21;58(7):373-381. doi: 10.1136/bjsports-2023-107563.
- Protocol paperLink provided by the sponsor.
- Primary resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request after the primary publications have been published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behnam Liaghat, MSc principal investigator
University of Sotuhern Denmark
Birgit Juul-Kristensen, PhD study director
University of Southern Denmark
Søren T Skou, PhD study chair
University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hypermobility Syndrome Shoulder and Shoulder Pain Chronic, run by University of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario Shoulder Instability Index (WOSI) questionnaire total score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869307, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.