Qigong Intervention for Fibromyalgia A Randomized Controlled Study

Study Rationale and Design:

Fibromyalgia is a chronic musculoskeletal condition characterized by widespread pain, debilitating fatigue, and reduced physical functioning, frequently accompanied by marked limitations in spinal mobility. Mind-body movement modalities such as Qigong demonstrate potential in fibromyalgia rehabilitation; however, comparative evidence elucidating the specific efficacy of dynamic mobility-oriented movement sets versus static posture-based regimens remains sparse.

This study is designed as a double-blind (participants and outcome assessors), two-arm randomized controlled pilot trial. A total of 36 female participants meeting the 2010 American College of Rheumatology (ACR) diagnostic criteria are allocated in a 1:1 ratio using computer-generated simple randomization to one of two active interventions: Mobility-Intensive Qigong (Group 1) or Static Posture-Based Qigong (Group 2). Participants are informed that the trial compares two gentle therapeutic exercise programs to maintain participant blinding, while data analysts and outcome assessors remain fully blinded to group allocation.

Sample Size Determination:

The sample size estimation was determined using Hamidiye Ethics Committee Biostatistics Guidelines and relevant literature referencing pain reduction (McGill Pain Questionnaire) with an effect size of Cohen's d = 1.26. Given the comparison of two active interventions, an anticipated large effect size of d = 1.0 was selected. Setting alpha at 0.05 and statistical power at 80% yielded a minimum required sample of 33 participants. To ensure equal distribution across groups and accommodate potential dropouts, the target sample was finalized at 36 participants.

Intervention Protocol:

Both interventions are delivered online under the live supervision of an experienced physiotherapist and certified Qigong instructor over 12 consecutive weeks (2 sessions per week, 45 minutes per session). Each session comprises 5 minutes of structured warm-up and participant check-in, followed by 40 minutes of protocol-specific Qigong exercises. Group 1 performs dynamic, flowing movements focusing on active multi-segmental joint mobility, muscle lengthening, and breath coordination. Group 2 focuses on sustained isometric postures, focused breath regulation, and static stretching to build postural stability and endurance. Participants who miss a live session are provided structured home-practice guidance; an adherence rate of at least 90% is required for per-protocol analysis.

Assessment Protocol and Settings:

Face-to-face outcome evaluations are carried out at baseline (prior to session 1) and post-intervention at the Akdeniz University Department of Physical Medicine and Rehabilitation in a standardized, climate-controlled setting. Each assessment requires approximately 45 minutes per subject.

• Primary Clinical Endpoints: Pain intensity and characteristics are quantified using the Short-Form McGill Pain Questionnaire (SF-MPQ, sensory and affective subscales) and a 100-mm Visual Analog Scale (VAS). Spinal mobility across cervical, thoracic, and lumbar segments (flexion, extension, lateral flexion) is measured objectively using an inclinometer.
• Secondary Clinical Endpoints: Functional exercise capacity is measured using the submaximal 6-Minute Walk Test (6MWT) performed strictly according to 2022 American Thoracic Society (ATS) technical standards. Fatigue severity is assessed via the 9-item Fatigue Severity Scale (FSS), and overall disease-specific functional impact is measured with the Revised Fibromyalgia Impact Questionnaire (FIQR).

Inclusion criteria

• Female patients aged between 30 and 50 years.
• Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology (ACR) criteria.
• Non-obese, defined as Body Mass Index (BMI) < 30 kg/m².
• Lack of clinical improvement despite receiving pharmacological treatment for more than 3 months.
• Willingness to adhere to the 12-week supervised online exercise program.

Exclusion criteria

• Pregnancy or currently breastfeeding.
• Presence of advanced musculoskeletal pathologies (e.g., inflammatory arthritis, severe osteoarthritis).
• Diagnosed neurological disorders or peripheral neuropathy.
• Known severe cardiovascular diseases.
• History of surgical intervention within the past 4 months.
• Participation in any regular physical exercise or rehabilitation program within the past 2 months prior to enrollment.