Clinical trial NCT03869307: Shoulder Exercises in Hypermobile Patients With Shoulder Symptoms
Official title: Shoulder Exercises in Patients With Hypermobility Spectrum Disorder and Long-lasting Shoulder Symptoms: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypermobility Syndrome Shoulder
Shoulder Pain Chronic
Shoulder Luxation
Keywords: Joint instability
Hypermobility
Shoulder
Strength training
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Esbjerg Municipality
name: The Danish Rheumatism Association
name: Region of Southern Denmark
name: Fund for Research, Quality and Education in Physiotherapy Practice
First posted: 2019-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

  1. musculoskeletal pain in minimum one shoulder for at least three months

     and/or
  2. 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Western Ontario Shoulder Instability Index (WOSI) questionnaire total score
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in pain level on numeric pain rating scale
timeFrame: 12 months.
measure: Change in symptom level on numeric rating scale
timeFrame: 12 months.
measure: Change in Checklist Individual Strength (CIS), fatigue subscale
timeFrame: 12 months.
measure: Change in Dartmouth Primary Care Cooperative Research Network/World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (COOP/WONCA)
timeFrame: 12 months.
measure: Change in Tampa Scale of Kinesiophobia (TSK-11)
timeFrame: 12 months.
measure: Change in EuroQol 5 dimension 5 level (EQ-5D-5L)
timeFrame: 12 months.
measure: Change in isometric shoulder strength
timeFrame: 16 weeks.
measure: Change in active and passive shoulder range of motion
timeFrame: 16 weeks
measure: Change in shoulder proprioception
timeFrame: 16 weeks
measure: Change in Patient Specific Functional Scale (PSFS)
timeFrame: 12 months.
measure: Change in clinical shoulder tests
timeFrame: 16 weeks.
measure: Adverse events
timeFrame: 12 months.
measure: Change in subscales of the Western Ontario Shoulder Instability Index (WOSI) questionnaire
timeFrame: 12 months.
measure: Physical Activity
timeFrame: Baseline
measure: Global Perceived Effect (GPE)
timeFrame: 16 weeks
measure: Compliance with exercise
timeFrame: 16 weeks
measure: Demographic
timeFrame: Baseline
measure: Anthropometrics
timeFrame: Baseline and 16 weeks
Other outcomes:
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 12 months.
measure: Patient-reported treatment failure
timeFrame: 12 months.
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: baseline
measure: Patient expectations
timeFrame: Baseline
Locations:
city: Esbjerg
country: Denmark
facility: GPs and physiotherapists
state: Region Of Southern Denmark
city: Middelfart
country: Denmark
facility: GPs and physiotherapists
state: Region Of Southern Denmark
city: Odense
country: Denmark
facility: GPs and physiotherapist
state: Region Of Southern Denmark
Study officials:
affiliation: University of Sotuhern Denmark
name: Behnam Liaghat, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Birgit Juul-Kristensen, PhD
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark, Næstved-Slagelse-Ringsted Hospitals
name: Søren T Skou, PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Karen Søgaard, PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Jens Søndergaard, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.