Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001966
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Mind-Body Therapy for Pain in Ehlers-Danlos Syndrome
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Mind-Body Therapy for Chronic Pain in Ehlers-Danlos Syndrome
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 Note if the symbol is unreadable it is four and one-half to 5-month study Patients not already enrolled in NHGRIs 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
Adult patients with Ehlers-Danlos syndrome who have chronic pain may be eligible for this 4 12 Note if the symbol is unreadable it is four and one-half to 5-month study Patients not already enrolled in NHGRIs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-HG-0054 | None | None | None |