Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial

Area of Science:

• Integrative and Complementary Medicine
• Rheumatology
• Clinical Trials

Background:

• Fibromyalgia is a chronic condition with unclear treatment efficacy.
• Acupuncture, a Traditional Chinese Medicine therapy, shows potential for various diseases.
• This study protocol addresses the need for evidence on acupuncture's effectiveness in treating fibromyalgia.

Purpose of the Study:

• To assess the effectiveness and safety of acupuncture for patients diagnosed with primary fibromyalgia.
• To evaluate the impact of acupuncture on clinical symptoms and quality of life in fibromyalgia patients.
• To provide clinical evidence for acupuncture as a non-pharmacological treatment for fibromyalgia.

Main Methods:

• A randomized, blinded, placebo-controlled trial involving 68 fibromyalgia patients.
• Allocation to either acupuncture or sham acupuncture groups for 8 weeks, with 16 weeks of follow-up.
• Primary outcomes measured by Visual Analogue Scale (VAS) and Revised Fibromyalgia Impact Questionnaire (FIQR) for pain intensity.

Main Results:

• The study is designed to collect data on pain intensity, fatigue, depression, sleep quality, and tender points.
• Secondary outcomes include SF-36, Beck Depression Inventory, Pittsburgh Sleep Quality Index, and patient satisfaction.
• Adverse events will be monitored throughout the trial.

Conclusions:

• This clinical trial will employ rigorous methods to evaluate acupuncture's efficacy and safety in fibromyalgia.
• Results are anticipated to offer clinical evidence supporting acupuncture's benefits for fibromyalgia symptom management.
• The findings may inform treatment guidelines for fibromyalgia, highlighting acupuncture's therapeutic potential.