Efficacy of Acupuncture in the Treatment of Fibromyalgia
| ISRCTN | ISRCTN74259594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74259594 |
| Protocol serial number | R01 AT00003 |
| Sponsor | National Center for Complementary and Alternative Medicine (NCCAM) (USA) |
| Funder | National Center for Complementary and Alternative Medicine (NCCAM) (USA) |
- Submission date
- 20/08/2004
- Registration date
- 21/09/2004
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Washington
Center for Clinical and Epidemiological Research
1730 Minor Ave., Suite 1760
Seattle
98101
United States of America
| Phone | +1 206 543 2260, +1 206 341 4439 |
|---|---|
| dedra@u.washington.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Fibromyalgia (FM) |
| Intervention | One hundred FM patients will participate in a 12-week 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | Male or Female, aged 18 and over with Fibromyalgia |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/09/2002 |
Locations
Countries of recruitment
- United States of America
Study participating centre
98101
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 05/07/2005 | Yes | No |
