Fibromyalgia
Conditions
Keywords
Fibromyalgia, Reflexology, Foot Reflexology, Chronic Pain, Sleep Disorders, Physical Therapy, TENS, Fibromyalgia Syndrome, Pain Management, Women Health, Complementary Therapy, Randomized Controlled Trial
Brief summary
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.
Detailed description
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and impaired quality of life. Women represent the majority of affected individuals, and many patients continue to experience persistent symptoms despite pharmacological treatment. Reflexology is a non-invasive complementary therapy involving pressure application to specific foot reflex zones and has been proposed as an adjunctive intervention for symptom management in fibromyalgia. This study is a prospective single-blinded randomized controlled trial designed to evaluate the effect of reflexology on pain, sleep quality, psychological distress, and functional activity in female patients with fibromyalgia. Sixty Egyptian female participants aged 18-65 years who meet fibromyalgia diagnostic criteria will be recruited and randomly allocated into two equal groups. The control group will receive conventional physical therapy consisting of aerobic exercise, resistance training, and transcutaneous electrical nerve stimulation (TENS). The experimental group will receive the same conventional physical therapy program in addition to foot reflexology. Both groups will receive treatment twice weekly for six weeks. Outcome measures will be assessed at baseline and post-treatment and include pressure pain threshold using algometry, the Arabic Fibromyalgia Impact Questionnaire, Arabic Pittsburgh Sleep Quality Index, Arabic Hospital Anxiety and Depression Scale, and Arabic Short Form-36 Health Survey. The study seeks to determine whether adding foot reflexology to conventional physical therapy improves pain, sleep quality, psychological status, and functional outcomes in women with fibromyalgia.
Interventions
BEHAVIORALFoot Reflexology
Foot 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.
OTHERConventional Physical Therapy
Conventional 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.
DEVICETranscutaneous Electrical Nerve Stimulation (TENS)
High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to participant group assignment throughout the study. Participants and treating therapists will not be blinded due to the nature of the interventions.
Intervention model description
Two-arm parallel randomized controlled trial comparing conventional physical therapy alone versus conventional physical therapy combined with foot reflexology in female patients with fibromyalgia.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Ability and willingness to provide written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Pain Threshold (PPT) | Baseline and 6 weeks | 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. |
| Fibromyalgia Symptom Impact (FIQ-A) | Baseline and 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality (PSQI-A) | Baseline and 6 weeks | 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. |
| Psychological Distress (HADS) | Baseline and 6 weeks | 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. |
| Functional Activity and Health-Related Quality of Life (SF-36v2) | Baseline and 6 weeks | 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. |
Countries
Egypt
Contacts
CONTACTGhada M Mohamed El-Hady Ismaeil, BSc, PT
Outcome results
None listed