STABLE Pilates for Hypermobility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old;
Self-reported hypermobility with confirmed or suspected diagnosis of hEDS/HSD;
Self-reported persistent pain ≥ 3 months;
A minimum of 3/10 self-reported pain intensity in the past week
Disqualifiers
Regular ongoing mind-body practice (e.g. Tai chi, yoga, pilates) defined as a regular weekly practice of at least 20min/week over the past 6 months;
Recent surgery or acute bone, joint or nerve injury (<6 months);
Have a history of a severe or progressive neurological or movement disorder;
Pregnant, planning to become pregnant during the study, or currently breast feeding;
Trial design
Design model
Parallel
Treatments tested in this trial
Pilates
BehavioralPilates is a gentle mind-body exercise with an emphasis on muscular control, postural awareness, and breathing that may be particularly well-suited for managing hypermobility. Exercises are mostly floor-based and focus on developing muscular strength and stability which may improve pain and symptom management
Education
BehavioralEducational seminars pertaining to hypermobility symptom management
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PilatesExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intervention Feasibility
Recruitment, Retention, Attendance
Time frame
Enrollment to end of intervention (week 6) and follow-up (week 12)2
Acceptability
Treatment Helpfulness Questionnaire (THQ): The THQ is a single-item measure that evaluates the perception of helpfulness of an intervention. Participants will be asked to rate the helpfulness of the intervention to which they are randomized on a scale of -5 (extremely harmful) to 5 (extremely helpful) with 0 indicating "neutral."
Time frame
Enrollment to end of intervention (week 6)Secondary outcomes
1
Pain intensity
The Patient Reported Outcomes Measurement Information System Profile (PROMIS-29) will be used to assess pain intensity. Scores range from 8-40 with higher scores indicating a greater presence of the corresponding construct.
Time frame
Baseline, week 6 and week 122
Pain interference
The Patient Reported Outcomes Measurement Information System Profile (PROMIS-29) will be used to assess pain interference. Scores range from 8-40 with higher scores indicating a greater presence of the corresponding construct.
Time frame
Baseline, week 6 and week 123
Bristol Questionnaire
The Bristol Impact of Hypermobility Questionnaire will be used to assess the self-reported functional impact of joint hypermobility. Higher scores indicate more severe functional impact
Time frame
Baseline, week 6 and week 124
WPI
The Widespread Pain Inventory (WPI) will be used to assess the widespreadness of body pain. Scores range from 0-19 with higher scores indicating more widespread pain.
Time frame
Baseline, week 6 and week 12Other outcomes
1
Pain Sensitivity
Pain sensitivity will be assessed using a Quantitative Sensory Testing (QST) battery. The QST assessment will include responses to innocuous stimuli, mechanical pain sensitivity, heat sensitivity, conditioned pain modulation, and temporal summation of pain (a measure of central sensitizability).
Time frame
Baseline testingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Bernard Osher Foundation
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov