Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome

NCT00001966 | Completed Phase 2

• 2 other identifiers: 00005400-HG-0054
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ehlers-Danlos Syndrome; Pain

Keywords

Adjustment; Alternative; Anxiety; Guided-Imagery; Meditation; Ehlers-Danlos Syndrome

Interventions

Mind-body therapy DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

National Human Genome Research Institute (NHGRI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Ainsworth SR, Aulicino PL. A survey of patients with Ehlers-Danlos syndrome. Clin Orthop Relat Res. 1993 Jan;(286):250-6.

  PMID: 8425354 BACKGROUND

• Beighton P, De Paepe A, Steinmann B, Tsipouras P, Wenstrup RJ. Ehlers-Danlos syndromes: revised nosology, Villefranche, 1997. Ehlers-Danlos National Foundation (USA) and Ehlers-Danlos Support Group (UK). Am J Med Genet. 1998 Apr 28;77(1):31-7. doi: 10.1002/(sici)1096-8628(19980428)77:13.0.co;2-o.

  PMID: 9557891 BACKGROUND

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Pain; Anxiety Disorders

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: December 10, 2002
• Study Start: January 1, 2000
• Study Completion: January 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-01

Locations

US (1)