Efficacy of Acupuncture in the Treatment of Fibromyalgia
| ISRCTN | ISRCTN74259594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74259594 |
| Secondary identifying numbers | R01 AT00003 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dedra Buchwald
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2001 |
| Completion date | 01/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
University of Washington
Seattle
98101
United States of America
98101
United States of America
Sponsor information
National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Research organisation
Research organisation
6707 Democracy Blvd room 401
Bethesda
20892
United States of America
"ROR" |
https://ror.org/00190t495 |
|---|
Funders
Funder type
Government
National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NCCAM
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
