Contact information
Type
Scientific
Primary contact
Dr Dedra Buchwald
ORCID ID
Contact details
University of Washington
Center for Clinical and Epidemiological Research
1730 Minor Ave.
Suite 1760
Seattle
98101
United States of America
+1 206 543 2260, +1 206 341 4439
dedra@u.washington.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R01 AT00003
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2001
Overall trial end date
01/09/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Male or Female, aged 18 and over with Fibromyalgia
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
01/09/2002
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Washington
Seattle
98101
United States of America
Funders
Funder type
Government
Funder name
National Center for Complementary and Alternative Medicine (NCCAM) (USA)
Alternative name(s)
NCCAM
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15998750
Publication citations
-
Results
Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D, A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia., Ann. Intern. Med., 2005, 143, 1, 10-19.