Hypermobile Ehlers-Danlos Syndrome Clinical Trial
— EDS-OXYOfficial title:
Oxytocin Treatment for Chronic Pain in Hypermobile Ehlers-Danlos Syndrome
The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 13, 2025 |
Est. primary completion date | May 13, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: 1) Premenopausal Females, Age >18 years 2) Clinical diagnosis of hypermobile EDS according to the 2017 criteria for hEDS 3) Menstrual periods (range from 8 to 42 days) 4) Pain level greater that pain score of 4 out of 10 on a Numeric Rating Scale in at least two of the following locations: back, neck, shoulders, elbows, wrist, hand joints, hips, knees, ankles, on most days over the 3 months preceding enrollment. 5) On a stable regimen for pain control without any expected increase in dose of pain medications during the study period. 6) All participants should have a negative urine pregnancy test and agree to use an acceptable method of contraception (abstinence or barrier methods). Exclusion Criteria: 1) Known allergy to OXT or preservatives in the medication 2) Pregnancy 3) Lactation 4) A confirmed clinical diagnosis of autoimmune disorders that lead to joint inflammation and joint pain such as SLE, RA, psoriatic arthritis, ankylosing spondylitis, scleroderma, and enteropathic arthritis 5) History of known cardiac arrhythmias (except for asymptomatic sinus tachycardia and sinus bradycardia) 6) Heart rate persistently greater than 110/min or less than 50 per minute 7) QTC of > 450 ms from EKG (electrocardiogram) test 8) Taking oral or other hormonal contraceptives 9) Individuals with a clinical condition which, in the view of the investigator compromises safety 10) Participating in another interventional study. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in participant's pain levels assessed by numerical rating | Change in reported pain following treatment with oxytocin compared to treatment with placebo as assessed by using the Numerical pain rating scale. | For each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. This difference will be compared between the two treatment arms. | |
Other | Change in participant's pain levels by evaluating pain experience | Change in reported pain following treatment with oxytocin compared to treatment with placebo as assessed by using the McGill Pain Questionnaire. | For each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. This difference will be compared between the two treatment arms. | |
Primary | Change in participant's subjective reported chronic pain | Change in the individual's subjective reported pain following treatment with oxytocin compared to treatment with placebo evaluated by using Brief Pain Inventory. | For each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. This difference will be compared between the two treatment arms. | |
Secondary | Change in heart rate patterns | Change in heart rate patterns following treatment with oxytocin compared to treatment with placebo for an objective functional outcome of pain as measured by Actiheart device. | For each arm we will compare changes in heart rate reported 3 days before infusion, 3 days of infusion, and 3 days post-infusion. This difference will be compared between the two treatment arms. | |
Secondary | Change in activity level | Change in activity level following treatment with oxytocin compared to treatment with placebo for an objective functional outcome of pain as measured by Actiheart device. | For each arm we will compare changes in activity levels reported 3 days before infusion, 3 days of infusion, and 3 days post-infusion. This difference will be compared between the two treatment arms. | |
Secondary | Changes in depression assessment | Change in reported signs of anxiety following treatment with oxytocin compared to treatment with placebo assessed by using the Hospital anxiety and depression scale. | For each arm we will compare depression levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. This difference will be compared between the two treatment arms. | |
Secondary | Changes in anxiety assessment | Change in reported signs of anxiety following treatment with oxytocin compared to treatment with placebo assessed by using the State-Trait Anxiety Inventory. | For each arm we will compare anxiety levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. This difference will be compared between the two treatment arms. |
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