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

Hypermobile Ehlers-Danlos Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04666896
• Other study ID #: B670201939864
• Secondary ID: BOF17/DOC/220
• Status: Terminated
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: July 9, 2020

Study information

• Verified date: March 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Hypermobile Ehlers-Danlos Syndrome
• Hypermobility Syndrome
• Multidirectional Subluxation of Shoulder
• Syndrome

Intervention

Other:
• Tailored home-based exercise therapy
exercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides.
• Standard home-based exercise therapy
The exercise program consisted of 4 types of exercises for training 1) balance and proprioception; 2) isometric strength; 3) rotator cuff muscles; and 4) open chain elevation

Locations

Country	Name	City	State
Belgium	Ghent University, department of rehabilitation sciences	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Western Ontario Shoulder Instability Index (WOSI)	The WOSI is a responsive patient-reported and disease-specific tool, designed to be used as the primary outcome measure in clinical trials that assess treatments for patients with shoulder instability. Range 0 - 2100 points. Higher scores express worse status.	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	The Disabilities of the Arm Shoulder and Hand (DASH)	The DASH is a region-specific questionnaire of upper extremity disability (range 0-100). Higher scores express worse status	Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Secondary	The Tampa Scale for Kinesiophobia (TSK)	The TSK is one of the most frequently used measures for evaluating general pain-related fear of movement. Range 17 - 68 points. Higher scores express worse status.	Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Secondary	The Patient-Specific Functional Scale (PSFS)	The PSFS is a patient-rated outcome measure designed to evaluate functional change. Patients were asked to identify 3 activities they were having difficulty with as a result of their shoulder instability, and to rate each activity on an 11-point Likert scale (0 = impossible to perform the activity; 10 = able to perform the activity without complaints or help). At each follow-up moment, the same 3 activities were rated. The total PSFS score was calculated by adding the scores for the 3 activities. Range 0-30 points. Higher scores express better status.	Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Secondary	The Global Rating of Change (GROC)	The GROC is a transitional scale used to quantify patient-perceived improvement. It can be used to assess the results of treatment since it defines the change in health status as perceived by the patient. We asked patients to rate whether or how much their shoulder has changed since the beginning of the study on a 11 point numerical scale ('How would you describe the change in your shoulder since the beginning of the treatment program?' with -5= a lot worse; 0 = unchanged; +5= fully recovered). Range -5 to 5 points. Higher scores express better status.	Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Secondary	Pain pressure thresholds (PPT)	PPTs were measured on five locations around the shoulder (local PPTs). Additionally, a distal PPT was measured at the midpoint of the quadriceps muscle.	Measured at baseline, 6 weeks, 12 weeks and 24 weeks