Qigong Intervention for Fibromyalgia
ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-50
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mobility-Intensive Qigong Exercise
Other interventionDynamic 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).
Static Posture-Based Qigong Exercise
Other interventionParticipants 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).
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Group 1: Mobility-Intensive QigongExperimental treatment 1 intervention
Group B: Static Posture-Based QigongActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
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.
Time frame
Baseline and post-intervention at Week 12Secondary outcomes
1
Change in Pain Dimensions Assessed by Short-Form McGill Pain Questionnaire (SF-MPQ)
Qualitative and sensory/affective pain dimensions are evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ). It consists of 15 descriptors (11 sensory, 4 affective) scored on a 4-point intensity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total score ranges from 0 to 45. Higher scores indicate greater pain severity. Changes from baseline to Week 12 are assessed.
Time frame
Baseline and post-intervention at Week 122
Change in Spinal Mobility Measured by Inclinometer
Spinal range of motion is evaluated objectively across cervical, thoracic, and lumbar segments (flexion, extension, and lateral flexion) using a digital/bubble inclinometer. Measurements are recorded in degrees (°). Higher values indicate greater range of motion and improved spinal mobility. Changes from baseline to Week 12 post-intervention are assessed.
Time frame
Baseline and post-intervention at Week 123
Change in Fatigue Severity Assessed by Fatigue Severity Scale (FSS)
Fatigue severity and its impact on daily activities are evaluated using the 9-item self-report Fatigue Severity Scale (FSS). Items are rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The total score represents the mean of all items (range: 1 to 7). Higher scores indicate more severe fatigue. Changes from baseline to Week 12 are assessed.
Time frame
Baseline and post-intervention at Week 124
Change in Disease Impact and Quality of Life Measured by Revised Fibromyalgia Impact Questionnaire (FIQR)
Disease severity, symptom impact, and health-related quality of life are assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The questionnaire comprises 21 questions across three domains (function, overall impact, symptoms) scored on an 11-point numeric scale (0 to 10). The total score ranges from 0 to 100, where higher scores reflect greater disease burden and poorer quality of life. Changes from baseline to Week 12 are assessed.
Time frame
Baseline and post-intervention at Week 12Sponsors and contacts
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Source ClinicalTrials.gov
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