Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorCairo University
About this trial
This randomized controlled trial aims to investigate the effect of foot reflexology on pain and sleep disorders in Egyptian female patients with fibromyalgia. Sixty female participants aged 18 to 65 years diagnosed with fibromyalgia will be randomly assigned into two equal groups. The control group will receive conventional physical therapy, including aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS), while the experimental group will receive the same treatment in addition to foot reflexology. Interventions will be delivered twice weekly for six weeks. Pain, sleep quality, psychological distress, and functional activity will be evaluated at baseline and after treatment using validated Arabic assessment tools and pressure pain threshold measurements. The study aims to determine whether reflexology provides additional benefits when combined with conventional physical therapy in women with fibromyalgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Egyptian female participants aged 18 to 65 years
Diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria
Moderate pain intensity
Poor sleep quality
Disqualifiers
Comorbid conditions affecting pain or sleep, including rheumatoid arthritis and related disorders
Previous reflexology treatment within the previous 6 months
Any medical condition preventing participation in physical therapy or reflexology intervention
Refusal or inability to comply with study procedures and follow-up requirements
Trial design
Design model
Parallel
Treatments tested in this trial
Foot Reflexology
BehavioralFoot reflexology will be delivered twice weekly for six weeks, with each session lasting 30 minutes. Moderate thumb and finger pressure will be applied bilaterally to standardized foot reflex zones associated with fibromyalgia symptom management.
Conventional Physical Therapy
Other interventionConventional physical therapy includes aerobic exercise, stretching, and low-load resistance training administered twice weekly for six weeks. Exercise programs will be individualized and progressively adjusted according to participant tolerance.
Transcutaneous Electrical Nerve Stimulation (TENS)
DeviceHigh-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 2 interventions
Group B: Experimental GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pressure Pain Threshold (PPT)
Pressure pain threshold will be assessed using a digital pressure algometer at predefined tender points. Three measurements will be obtained and averaged for analysis. Higher values indicate reduced pain sensitivity.
Time frame
Baseline and 6 weeks2
Fibromyalgia Symptom Impact (FIQ-A)
Fibromyalgia symptom impact will be assessed using the Arabic version of the Fibromyalgia Impact Questionnaire (FIQ-A). Scores range from 0 to 100, with higher scores indicating greater disease impact and symptom burden.
Time frame
Baseline and 6 weeksSecondary outcomes
1
Sleep Quality (PSQI-A)
Sleep quality will be assessed using the Arabic version of the Pittsburgh Sleep Quality Index (PSQI-A). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality and greater sleep disturbance.
Time frame
Baseline and 6 weeks2
Psychological Distress (HADS)
Psychological distress will be evaluated using the Arabic Hospital Anxiety and Depression Scale (HADS), including anxiety and depression subscales. Each subscale score ranges from 0 to 21 and the total score ranges from 0 to 42. Higher scores indicate greater psychological distress.
Time frame
Baseline and 6 weeks3
Functional Activity and Health-Related Quality of Life (SF-36v2)
Functional activity and health-related quality of life will be assessed using the Arabic version of the Short Form-36 Health Survey Version 2 (SF-36v2). Scores range from 0 to 100, with higher scores indicating better health status, physical functioning, and quality of life.
Time frame
Baseline and 6 weeksSponsors and contacts
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Source ClinicalTrials.gov