NCT03869307

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2021

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

March 5, 2019

Last Update Submit

August 4, 2022

Conditions

Hypermobility Syndrome ShoulderShoulder Pain ChronicShoulder Luxation

Keywords

Joint instabilityHypermobilityShoulderStrength training

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 weeks

Secondary Outcomes (18)

  • Change in pain level on numeric pain rating scale

    12 months.

  • Change in symptom level on numeric rating scale

    12 months.

  • Change in Checklist Individual Strength (CIS), fatigue subscale

    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)

    12 months.

  • Change in Tampa Scale of Kinesiophobia (TSK-11)

    12 months.

  • +13 more secondary outcomes

Other Outcomes (4)

  • Patient Acceptable Symptom State (PASS)

    12 months.

  • Patient-reported treatment failure

    12 months.

  • Change in Pain Self-Efficacy Questionnaire (PSEQ)

    baseline

  • +1 more other outcomes

Study Arms (2)

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.

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.

Other: Exercise

Interventions

ExerciseOTHER

The exercise programme includes exercises identified in literature to target scapular and rotator cuff muscles.

Shoulder stability exercisesShoulder strengthening exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Steroid injection in the affected shoulder within three months
  • Inability to speak and understand Danish.
  • Unable to comply with protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GPs and physiotherapists

Esbjerg, Region Syddanmark, Denmark

Location

GPs and physiotherapists

Middelfart, Region Syddanmark, Denmark

Location

GPs and physiotherapist

Odense, Region Syddanmark, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 33261635BACKGROUND

  • Liaghat 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.

    PMID: 35649707RESULT

  • Liaghat 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.

    PMID: 35065941RESULT

  • Liaghat 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.

    PMID: 38253436DERIVED

Related Links

MeSH Terms

Conditions

Shoulder DislocationJoint Instability

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Behnam Liaghat, MSc

    University of Sotuhern Denmark

    PRINCIPAL INVESTIGATOR

  • Birgit Juul-Kristensen, PhD

    University of Southern Denmark

    STUDY DIRECTOR

  • Søren T Skou, PhD

    University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals

    STUDY CHAIR

  • Karen Søgaard, PhD

    University of Southern Denmark

    STUDY CHAIR

  • Jens Søndergaard, MD, PhD

    University of Southern Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 11, 2019

Study Start

April 1, 2019

Primary Completion

February 28, 2021

Study Completion

November 28, 2021

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Data will be made available upon reasonable request after the primary publications have been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Ultimo 2022
Access Criteria
Data will be made available upon reasonable request after the primary publications have been published.

Locations

DK(3)