Pain Clinical Trial
Official title:
A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome
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.
Ehlers-Danlos Syndrome (EDS) encompasses a spectrum of connective tissue diseases thought to result from defects in collagen formation. People with EDS are often affected by chronic, progressive pain poorly responsive to conventional treatment. We propose to investigate the efficacy of mind-body therapy for treatment of chronic pain in Ehlers-Danlos Syndrome. A cohort of adult subjects will be treated with mind-body therapy in a pilot study to assess the efficacy and acceptability of this treatment modality. The primary outcome measure will be change in pain as scored with a standardized inventory. We will also evaluate general health status, psychological variables, medication usage, and physical performance abilities. ;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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