Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 2:35 AM
Study NCT ID:
NCT00001966
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004535', 'term': 'Ehlers-Danlos Syndrome'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-01', 'completionDateStruct': {'date': '2001-01'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '2000-01-18', 'studyFirstSubmitQcDate': '2002-12-09', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Adjustment', 'Alternative', 'Anxiety', 'Guided-Imagery', 'Meditation', 'Ehlers-Danlos Syndrome'], 'conditions': ['Ehlers-Danlos Syndrome', 'Pain']}, 'referencesModule': {'references': [{'pmid': '8425354', 'type': 'BACKGROUND', 'citation': 'Ainsworth SR, Aulicino PL. A survey of patients with Ehlers-Danlos syndrome. Clin Orthop Relat Res. 1993 Jan;(286):250-6.'}, {'pmid': '9557891', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAdult 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.\n\nParticipants 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinical diagnosis of classical or hypermobile EDS based on history and physical examination by a study investigator.\n\nSubjectively suffer from chronic pain (defined as pain occurring at least weekly).\n\nMust agree to not seek mind-body therapy or other similar interventions outside of this study during the time under investigation.\n\nAble to give informed consent.\n\nNo minors (under 18 years of age).\n\nNot currently using formal mind-body or similar therapy for treatment of chronic pain.\n\nNo major surgical procedure within 90 days or intending to undergo such a procedure during the time course of this study.\n\nNot decisionally impaired subjects.\n\nNo 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.'}, 'identificationModule': {'nctId': 'NCT00001966', 'briefTitle': 'Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome', 'orgStudyIdInfo': {'id': '000054'}, 'secondaryIdInfos': [{'id': '00-HG-0054'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Mind-body therapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Human Genome Research Institute (NHGRI)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}}}}