Qigong Intervention for Fibromyalgia: Improving Spinal Mobility in Fibromyalgia Patients: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
This randomized controlled pilot study investigates the comparative efficacy of mobility-intensive Qigong exercises versus static posture-based Qigong exercises in patients diagnosed with fibromyalgia. Participants are randomly allocated to either a mobility-intensive Qigong intervention group or a static posture-based Qigong intervention group. The primary objectives are to evaluate improvements in spinal mobility and reductions in pain levels. Secondary outcomes include enhancements in functional exercise capacity, reductions in fatigue severity, and improvements in health-related quality of life. All outcome assessments are conducted at baseline and upon completion of the intervention program.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded by presenting the study as a comparison between two gentle therapeutic exercise programs without disclosing experimental designations. Outcome assessors conducting face-to-face evaluations and data analysts remain blinded to group allocations throughout the trial.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1: Mobility-Intensive Qigong
Participants receive dynamic and fluid mobility-intensive Qigong exercises focusing on active range of motion, muscle flexibility, muscle strengthening, and breath coordination under online physiotherapist supervision (12 weeks, 2 sessions/week, 45 minutes/session).
干预措施: Mobility-Intensive Qigong Exercise (Other)
Static Posture-Based Qigong
Participants receive static posture-based Qigong exercises consisting of sustained isometric postures, breath regulation, and alignment control to enhance postural stability, static endurance, and core strengthening under online physiotherapist supervision (12 weeks, 2 sessions/week, 45 minutes/session).
干预措施: Static Posture-Based Qigong Exercise (Other)
结局指标
主要结局
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Baseline and post-intervention at Week 12
Pain intensity is evaluated using a 100-mm Visual Analog Scale (VAS), where 0 mm indicates "no pain" and 100 mm indicates "unbearable pain." Participants mark their perceived pain intensity on a horizontal 100-mm line. Higher scores represent greater pain severity. Changes from baseline to the end of the 12-week intervention are assessed.
次要结局
- Change in Pain Dimensions Assessed by Short-Form McGill Pain Questionnaire (SF-MPQ)(Baseline and post-intervention at Week 12)
- Change in Spinal Mobility Measured by Inclinometer(Baseline and post-intervention at Week 12)
- Change in Fatigue Severity Assessed by Fatigue Severity Scale (FSS)(Baseline and post-intervention at Week 12)
- Change in Disease Impact and Quality of Life Measured by Revised Fibromyalgia Impact Questionnaire (FIQR)(Baseline and post-intervention at Week 12)
- Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)(Baseline and post-intervention at Week 12)
研究者
Meryem Aksarı Gedikli
Physical Therapist, PhD Candidate
Saglik Bilimleri Universitesi