Effects of acupuncture on patients with fibromyalgia

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60217348

Enrollment

150

Registered

2010-10-19

Start date

2010-10-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia syndrome Musculoskeletal Diseases Other soft tissue disorders, not elsewhere classified

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026