Using oxytocin to treat chronic pain in women with hypermobile Ehlers-Danlos syndrome
Oxytocin Treatment for Chronic Pain in Hypermobile Ehlers-Danlos Syndrome
This study is testing if oxytocin can help reduce chronic pain in women with hypermobile Ehlers-Danlos syndrome.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05405257 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effects of intravenous oxytocin on chronic pain in female adult patients diagnosed with hypermobile Ehlers-Danlos syndrome (hEDS). The study will be conducted at a single site and will include two treatment periods: one with oxytocin and one with a placebo, with a one-month washout period in between. Participants will be blinded to the treatment order and will undergo daily pain evaluations using a questionnaire during each treatment phase. The study also includes assessments for anxiety and depression, and participants will wear a device to monitor heart rate.
Who should consider this trial
Good fit: Ideal candidates are premenopausal females over 18 years old with a clinical diagnosis of hypermobile EDS and chronic moderate to severe pain.
Not a fit: Patients with known allergies to oxytocin, those who are pregnant or lactating, or those with certain autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing chronic pain in women with hypermobile Ehlers-Danlos syndrome.
How similar studies have performed: While the use of oxytocin for pain management is an emerging area, this specific approach in hypermobile EDS is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Brendan Lee, MD, PhD — Baylor College of Medicine
- Study coordinator: Alyssa Tran, BS
- Email: alyssat@bcm.edu
- Phone: 8328224264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.