Clinical trial NCT04666896: Patient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability
Official title: Effectiveness of a 6-month Home-based Exercise Program for Treating Shoulder Instability in Patients With Hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): A Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypermobile Ehlers-Danlos Syndrome
Hypermobility Syndrome
Multidirectional Subluxation of Shoulder
Keywords: Hypermobile Ehlers-Danlos syndrome
Hypermobility Spectrum Disorder
Mutlidirectional shoulder instability
Telerehabilitation
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 21
Sex: FEMALE
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: For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Consequently, evidence-based treatment approaches for the hEDS/HSD population are scarce. Therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.

Detailed description: The main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (MDI) in patients diagnosed with the hypermobile type of The Ehlers-Danlos syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD). Patients were randomly assigned to either the control group (B: evidence-based tailored care) or the experimental group (A: evidence-based standard care). Both groups received a home-based exercise program of 24 weeks. The primary outcome measure was the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH), Tampa Scale for Kinesiophobia (TSK), Patient-Specific Functional Scale (PSFS), Global Rating of Change (GROC), and pain pressure thresholds (PPTs). Outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).

Eligibility criteria: Inclusion Criteria:

* Female
* 18-65 years
* Patients diagnosed by a medical doctor with generalized HSD or hEDS, according to the diagnostic criteria for hEDS and HSD as stated in the recently published international classification for the Ehlers-Danlos syndromes
* Patients diagnosed with multidirctional shoulder instability (MDI): The diagnosis of MDI was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, Gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study.

Exclusion Criteria:

* pregnancy during study participation
* patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study

Primary outcomes:
measure: Change in Western Ontario Shoulder Instability Index (WOSI)
timeFrame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks, in order to assess the change in WOSI from baseline to 6 weeks, 12 weeks, and 24 weeks
Secondary outcomes:
measure: The Disabilities of the Arm Shoulder and Hand (DASH)
timeFrame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
measure: The Patient-Specific Functional Scale (PSFS)
timeFrame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
measure: The Global Rating of Change (GROC)
timeFrame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
measure: Pain pressure thresholds (PPT)
timeFrame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University, department of rehabilitation sciences
state: Oost-Vlaanderen
Study officials:
affiliation: Centre of Medical Genetics
name: Fransiska Malfait, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: