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

March 17, 2021 updated by: University Ghent

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Ghent University, Department of Rehabilitation Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evidence-based tailored care (group A)
Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data.
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.
Active Comparator: Evidence-based standard care (group B)
This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Ontario Shoulder Instability Index (WOSI)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Disabilities of the Arm Shoulder and Hand (DASH)
Time Frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
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
The Tampa Scale for Kinesiophobia (TSK)
Time Frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
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
The Patient-Specific Functional Scale (PSFS)
Time Frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
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
The Global Rating of Change (GROC)
Time Frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
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
Pain pressure thresholds (PPT)
Time Frame: Measured at baseline, 6 weeks, 12 weeks and 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Fransiska Malfait, Prof. Dr., Centre of Medical Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2019

Primary Completion (Actual)

July 9, 2020

Study Completion (Actual)

July 9, 2020

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201939864
  • BOF17/DOC/220 (Other Grant/Funding Number: Bijzonder Onderzoeksfonds (BOF))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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