Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Jorge Vas


Contact details

Pain Treatment Unit
UGC Doña Mercedes
Cl/ Segovia s/n
Dos Hermanas

Additional identifiers

EudraCT number number

Protocol/serial number

CS: PI0436/09; ISCIII-FIS:PI10/00675

Study information

Scientific title

Effects of acupuncture on patients with fibromyalgia: a multicentre randomised controlled trial


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.

Ethics approval

Clinical Trials Ethics Committee of the Andalusian Regional Government, 07/04/2010

Study design

Multicentre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Fibromyalgia syndrome


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.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Changes in pain intensity, measured on a visual analogue scale (VAS), at the conclusion of treatment (10 weeks)

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Pain Treatment Unit
Dos Hermanas

Sponsor information


Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)

Sponsor details

C/ Sinesio Delgado

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: PI10/00675)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Andalusian Regional Ministry of Health (Spain) (ref: PI0436/09)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2011 protocol in:
2016 results in:

Publication citations

  1. Protocol

    Vas J, Modesto M, Aguilar I, Santos-Rey K, Benítez-Parejo N, Rivas-Ruiz F, Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial., Trials, 2011, 12, 59, doi: 10.1186/1745-6215-12-59.

  2. Results

    Vas J, Santos-Rey K, Navarro-Pablo R, Modesto M, Aguilar I, Campos MÁ, Aguilar-Velasco JF, Romero M, Párraga P, Hervás V, Santamaría O, Márquez-Zurita C, Rivas-Ruiz F, Acupuncture for fibromyalgia in primary care: a randomised controlled trial, Acupunct Med, 2016, doi: 10.1136/acupmed-2015-010950.

Additional files

Editorial Notes

18/02/2016: Publication reference added.