Back to resultsPatient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability
Primary Purpose
Hypermobile Ehlers-Danlos Syndrome, Hypermobility Syndrome, Multidirectional Subluxation of Shoulder
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Tailored home-based exercise therapy
Standard home-based exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hypermobile Ehlers-Danlos Syndrome focused on measuring Hypermobile Ehlers-Danlos syndrome, Hypermobility Spectrum Disorder, Mutlidirectional shoulder instability, Telerehabilitation
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
Sites / Locations
- Ghent University, department of rehabilitation sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Evidence-based tailored care (group A)
Evidence-based standard care (group B)
Arm Description
Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data.
This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04666896
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19, this pilot study ended prematurely.
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
July 9, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobile Ehlers-Danlos Syndrome, Hypermobility Syndrome, Multidirectional Subluxation of Shoulder
Keywords
Hypermobile Ehlers-Danlos syndrome, Hypermobility Spectrum Disorder, Mutlidirectional shoulder instability, Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evidence-based tailored care (group A)
Arm Type
Experimental
Arm Description
Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data.
Arm Title
Evidence-based standard care (group B)
Arm Type
Active Comparator
Arm Description
This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format.
Intervention Type
Other
Intervention Name(s)
Tailored home-based exercise therapy
Intervention Description
exercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides.
Intervention Type
Other
Intervention Name(s)
Standard home-based exercise therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Western Ontario Shoulder Instability Index (WOSI)
Description
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.
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
Secondary Outcome Measure Information:
Title
The Disabilities of the Arm Shoulder and Hand (DASH)
Description
The DASH is a region-specific questionnaire of upper extremity disability (range 0-100). Higher scores express worse status
Time Frame
Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Title
The Tampa Scale for Kinesiophobia (TSK)
Description
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.
Time Frame
Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Title
The Patient-Specific Functional Scale (PSFS)
Description
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.
Time Frame
Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Title
The Global Rating of Change (GROC)
Description
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.
Time Frame
Measured at baseline, 6 weeks, 12 weeks and 24 weeks
Title
Pain pressure thresholds (PPT)
Description
PPTs were measured on five locations around the shoulder (local PPTs). Additionally, a distal PPT was measured at the midpoint of the quadriceps muscle.
Time Frame
Measured at baseline, 6 weeks, 12 weeks and 24 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender 'female' on ID (passport)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fransiska Malfait, Prof. Dr.
Organizational Affiliation
Centre of Medical Genetics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University, department of rehabilitation sciences
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Patient-based Care Versus Standard Care for Patients With hEDS/HSD and Multidirectional Shoulder Instability
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