Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010504
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2001-02-02
Brief Title:
Acupuncture in Fibromyalgia
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Pilot Study of Acupuncture in Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2008-03
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:
Fibromyalgia is the second most common rheumatic disorder affecting approximately 8-10 million persons in the US and is characterized by widespread musculoskeletal pain and soft tissue tenderness upon examination This study focuses on the use of acupuncture as a mode of therapy for fibromyalgia The issues under examination are 1 the optimal duration of treatment 2 the independent and synergistic effects of needle placement and needle stimulation and 3 appropriate control strategies The proposal utilizes a randomized blinded sham-controlled design to achieve these aims Subjects are randomly assigned to one of four groups 1active site with stimulation 2 active site without stimulation 3 sham site with stimulation and 4 sham site without stimulation All subjects will receive acupuncture at escalating frequency beginning at once per week and ending at 3 times per week This forced titration design allows for the detection of inter-subject differences in responsiveness to acupuncture as well as the factors which may predict responsiveness or lack thereof Secondary goals of the study are to collect data on the mechanism safety and cost-effectiveness of acupuncture in fibromyalgia and to determine the optimal outcome measures for a full scale research clinical trial
Detailed Description:
None
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 |
|---|---|---|---|
| R01AT000004-01 | NIH | None | httpsreporternihgovquickSearchR01AT000004-01 |