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Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001966
First received: January 18, 2000
Last updated: March 3, 2008
Last verified: January 2000
  Purpose

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.


Condition Intervention Phase
Ehlers-Danlos Syndrome
Pain
Drug: Mind-body therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 40
Study Start Date: January 2000
Estimated Study Completion Date: January 2001
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001966

Locations
United States, Maryland
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001966     History of Changes
Other Study ID Numbers: 000054, 00-HG-0054
Study First Received: January 18, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adjustment
Alternative
Anxiety
Guided-Imagery
Meditation
Ehlers-Danlos Syndrome

Additional relevant MeSH terms:
Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014