Effects of acupuncture on patients with fibromyalgia

ISRCTN	ISRCTN60217348
DOI	https://doi.org/10.1186/ISRCTN60217348
Secondary identifying numbers	CS: PI0436/09; ISCIII-FIS:PI10/00675

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

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/10/2010
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

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

C/ Sinesio Delgado, 6
Madrid
28029
Spain

"ROR"	https://ror.org/00ca2c886

Funders

Funder type

Research organisation

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

18/02/2016: Publication reference added.