Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010764
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2001-02-02
Brief Title:
Efficacy of Acupuncture in the Treatment of Fibromyalgia
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Efficacy of Acupuncture in the Treatment of 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 FM one of the most common rheumatic conditions is a condition of unknown etiology characterized by widespread muscle pain and stiffness Treatment is generally unsatisfactory and most randomized controlled treatment trials have been unable to demonstrate a sustained effective intervention A single brief trial of electroacupuncture demonstrated remarkable improvement among patients with FM although lasting effects were not evaluated Nonetheless the recently published National Institutes of Health Consensus Development Statement on Acupuncture says musculoskeletal conditions such as fibromyalgia myofascial pain are conditions for which acupuncture may be beneficial Thus 96 patients will be recruited from a referral clinic for fatigue for a 12 week 24 treatments trial These patients will be randomized into 3 control groups and 1 true acupuncture group The control groups will consist of a group receiving acupuncture treatment for an unrelated condition morning sickness a group receiving needle insertion at non-channel non-point locations and a true placebo group This latter group will have acupuncture needle guides tapped on the skin then needles tapped Thus the specific aims of this study are to 1 evaluate the short and long term efficacy and side effects of a 12 week randomized controlled trial of bi-weekly acupuncture in the treatment of FM 2 establish the most useful and scientifically sound control group for studies of acupuncture using FM as a model for conditions characterized by chronic pain 3 use both subjective and objective measures of overall health and pain to determine the optimal time length of treatment and 4 examine the concordance of allopathic and acupuncture-based measures of outcome For the purposes of this study subjects will be asked to complete a unique set of study measures at enrollment at 4 8 and 12 weeks and then again at 1 and 6 months post-treatment Our primary outcomes will be patient global assessment subjective pain and mean number of tender points Secondary outcomes will be pain threshold analgesic use physician global assessment functional status sleep psychological distress and fatigue Thus this trial will have both immediate and longer term implications for the scientific study of acupuncture as well as the clinical care of the estimated 5 million patients with FM in the US From a methodological point of view the proposed trial will establish the most appropriate methods for choosing a control group should larger trials be conducted suggest the optimum duration of treatment and evaluate the utility of diverse allopathic and alternative outcome measures Of equal importance however this research will test and potentially establish the effectiveness of acupuncture
Detailed Description:
See brief summary
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