Condition category
Musculoskeletal Diseases
Date applied
03/10/2010
Date assigned
19/10/2010
Last edited
18/02/2016
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 Jorge Vas

ORCID ID

Contact details

Pain Treatment Unit
UGC Doña Mercedes
Cl/ Segovia s/n
Dos Hermanas
41700
Spain
-
jorgef.vas.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Fibromyalgia syndrome

Intervention

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

Other

Phase

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

01/10/2010

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

150

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

01/10/2010

Recruitment end date

01/04/2013

Locations

Countries of recruitment

Spain

Trial participating centre

Pain Treatment Unit
Dos Hermanas
41700
Spain

Sponsor information

Organisation

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

Sponsor details

C/ Sinesio Delgado
6
Madrid
28029
Spain

Sponsor type

Research organisation

Website

Funders

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

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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: http://www.ncbi.nlm.nih.gov/pubmed/21356075
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26879181

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.