Patient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability

University Ghent

Status: Terminated

Conditions: Multidirectional Subluxation of Shoulder; Hypermobile Ehlers-Danlos Syndrome; Hypermobility Syndrome

Treatments: Other: Tailored home-based exercise therapy; Other: Standard home-based exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04666896

BOF17/DOC/220 (Other Grant/Funding Number)

B670201939864

Details and patient eligibility

About

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.

Full 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).

Enrollment: 21 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Evidence-based tailored care (group A)

Experimental group

Description:

Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data.

Treatment:

Other: Tailored home-based exercise therapy

Evidence-based standard care (group B)

Active Comparator group

Description:

This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format.

Treatment:

Other: Standard home-based exercise therapy