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Effects of acupuncture on patients with fibromyalgia
DOI 10.1186/ISRCTN60217348
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of acupuncture on patients with fibromyalgia
Scientific title Effects of acupuncture on patients with fibromyalgia: a multicentre randomised controlled trial
Acronym N/A
Serial number at source CS: PI0436/09; ISCIII-FIS:PI10/00675
Study hypothesis Acupuncture can alleviate the pain experienced by patients with fibromyalgia (FM), either in its simple form or associated with severe depression, to a greater extent than can sham acupuncture. In addition, the application of this technique produces an improvement in patients' well-being, reduces levels of depression, combats dysfunction, enhances health-related quality of life and moderates the consumption of medicaments used as a conventional therapy, by reducing treatment-related disorders, without producing any such disorder itself to any significant degree.
Lay summary
Ethics approval Clinical Trials Ethics Committee of the Andalusian Regional Government approved on the 7th April 2010
Study design Multicentre randomised controlled trial
Countries of recruitment Spain
Disease/condition/study domain Fibromyalgia syndrome
Participants - inclusion criteria 1. Out-patients
2. Aged over 17 years, either sex
3. Diagnosed with fibromyalgia according to American Rheumatology College (ARC) criteria
4. Have not previously received acupuncture
5. The Hamilton Scale (HAMD) is used to classify the patients into two sub-groups (cut-off point: 21), with or without severe depression
Participants - exclusion criteria 1. Suffering pain for a reason other than fibromyalgia
2. Receiving anticoagulant treatment
3. Pregnant or nursing
4. Involved in work-related litigation for reasons concerning fibromyalgia
Anticipated start date 01/10/2010
Anticipated end date 01/04/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 150
Interventions The participants in the study will receive a total of nine acupuncture sessions (one per week), either true or sham.

A. True acupuncture (TA):
Individualised acupuncture, applied in accordance with pain characteristics and the diagnostic criteria of traditional Chinese medicine, to obtain Deqi (the sensation that ensures the correct localisation of the insertion point and its depth).

B. Sham acupuncture (SA):
The patient lies face down, and the insertion of needles into the dorsal and lumbar regions is simulated.

The treatment sessions, both TA and SA, will be performed at a rate of one per week for nine weeks. The healthcare personnel applying the different treatments have taken a training course of at least 300 hours in the subject and have more than three years’ practical experience in its application.
Primary outcome measure(s) Changes in pain intensity, measured on a visual analogue scale (VAS), at the conclusion of treatment (10 weeks)
Secondary outcome measure(s) 1. Changes in levels of depression, measured on the Hamilton Scale (HAMD), at the conclusion of treatment and after six months
2. Changes in the overall indicator value and in the various subscales of the Spanish version of the Fibromyalgia Impact Questionnaire (FIQ), at the conclusion of treatment and at six and twelve months following the start of treatment
3. Changes in pain intensity, measured on the VAS, at six and twelve months following the start of treatment
4. Changes in the pain threshold and the number of painful sites identified by an experienced evaluator, using a pressure algometer. Measured by comparing baseline values with those at end of treatment and at six and twelve months.
5. Changes in health-related quality of life, in accordance with version 2 of the SF-12 questionnaire
6. Consumption of antidepressant medication, analgesics and NSAIDs (prescribed or otherwise) at the time the treatment groups are determined and during follow up (at each treatment session, at the end of treatment and after six and twelve months)
7. Treatment expectations and credibility
8. Control of the treatment
Sources of funding 1. Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: PI10/00675)
2. Andalusian Regional Ministry of Health (Spain) (ref: PI0436/09)
Trial website
Publications 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21356075
Contact name Dr  Jorge  Vas
  Address Pain Treatment Unit
UGC Doña Mercedes
Cl/ Segovia s/n
  City/town Dos Hermanas
  Zip/Postcode 41700
  Country Spain
  Email jorgef.vas.sspa@juntadeandalucia.es
Sponsor Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
  Address C/ Sinesio Delgado, 6
  City/town Madrid
  Zip/Postcode 28029
  Country Spain
Date applied 03/10/2010
Last edited 03/03/2011
Date ISRCTN assigned 19/10/2010
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