Effects of acupuncture on patients with fibromyalgia

ISRCTN	ISRCTN60217348
DOI	https://doi.org/10.1186/ISRCTN60217348
Protocol serial number	CS: PI0436/09; ISCIII-FIS:PI10/00675
Sponsor	Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Funders	Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: PI10/00675), Andalusian Regional Ministry of Health (Spain) (ref: PI0436/09)

Submission date: 03/10/2010
Registration date: 19/10/2010
Last edited: 18/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jorge Vas
Scientific

Pain Treatment Unit
UGC Doña Mercedes
Cl/ Segovia s/n
Dos Hermanas
41700
Spain

Email	jorgef.vas.sspa@juntadeandalucia.es

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of acupuncture on patients with fibromyalgia: a multicentre randomised controlled trial
Study objectives	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(s)	Clinical Trials Ethics Committee of the Andalusian Regional Government, 07/04/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Changes in pain intensity, measured on a visual analogue scale (VAS), at the conclusion of treatment (10 weeks)
Key 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
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/10/2010
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

Spain

Study participating centre

Pain Treatment Unit

Dos Hermanas
41700
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No
Protocol article	protocol	28/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/02/2016: Publication reference added.