Condition category
Musculoskeletal Diseases
Date applied
20/08/2004
Date assigned
21/09/2004
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

National Center for Complementary and Alternative Medicine (NCCAM) (USA)

Sponsor details

6707 Democracy Blvd room 401
Bethesda
20892
United States of America

Sponsor type

Research organisation

Website

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

  1. 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.

Additional files

Editorial Notes