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Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome

CompletedPhase 2NCT00001966
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This study will assess the effectiveness of mind-body therapy in relieving pain in patients with Ehlers-Danlos syndrome. This syndrome is a hereditary condition caused by a connective tissue defect and is often associated with chronic pain poorly controlled by medication or physical therapy. Mind-body therapy comprises various complementary or alternative medicine techniques such as meditation, guided imagery, stress management, and group psychotherapy. Adult patients with Ehlers-Danlos syndrome who have chronic pain may be eligible for this 4 1/2 \[Note: if the symbol is unreadable, it is four and one-half\] to 5-month study. Patients not already enrolled in NHGRI's protocol 97-HG-0089 will undergo a history, physical examination, and brief interview before being accepted. Participants will attend 2-hour group sessions of mind-body therapy at NIH each week for at least 10 weeks. They will receive training in meditation, yoga breathing, guided imagery, and stress management in these sessions and will be asked to also practice the treatments at home each day. Patients may continue their regular medications and pain treatment with their private physicians during the course of the study. Participants will fill out a packet of questionnaires about their pain, health, and quality of life at three intervals: when they enroll in the study, at the end of treatment, and 12 weeks after treatment ends. At these same time intervals, patients will come to NIH for a test of their physical ability to walk and climb stairs. Patients will keep a diary and pain symptoms and medications for 1 week before treatment begins and 1 week after it ends, and will fill out questionnaires about pain during the entire study period.

Study details

Official title
A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome
Conditions
  • Ehlers-Danlos Syndrome
  • Pain
Interventions
  • Drug: Mind-body therapy
Sponsor
National Human Genome Research Institute (NHGRI)
Organization
National Institutes of Health Clinical Center (CC)
Start date
2000-01
Sex
All
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Clinical diagnosis of classical or hypermobile EDS based on history and physical examination by a study investigator. Subjectively suffer from chronic pain (defined as pain occurring at least weekly). Must agree to not seek mind-body therapy or other similar interventions outside of this study during the time under investigation. Able to give informed consent. No minors (under 18 years of age). Not currently using formal mind-body or similar therapy for treatment of chronic pain. No major surgical procedure within 90 days or intending to undergo such a procedure during the time course of this study. Not decisionally impaired subjects. No previous diagnosis or hospitalization for a psychotic condition(s). Specifically, no history of illness involving altered perception of reality. Psychiatric diagnoses such as depression or anxiety will not exclude participation.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00001966