Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P.T.REC/012/006040 | Other Identifier | Research Ethical Committee, Faculty of Physical Therapy, Cairo University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Participants will receive conventional physical therapy including aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS) twice weekly for six weeks. |
|
| Experimental Group | Experimental | Participants will receive conventional physical therapy in addition to foot reflexology twice weekly for six weeks. Conventional physical therapy includes aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS). Foot reflexology sessions will be conducted for 30 minutes per session following standardized reflexology protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot Reflexology | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| 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. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| Psychological Distress (HADS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada M Mohamed El-Hady Ismaeil, BSc, PT | Contact | +201005677669 | 10722018823327@pg.cu.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dekernis General Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35744 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27763930 | Background | Akin Korhan E, Uyar M, Eyigor C, Yont GH, Khorshid L. Effects of Reflexology on Pain in Patients With Fibromyalgia. Holist Nurs Pract. 2016 Nov/Dec;30(6):351-359. doi: 10.1097/HNP.0000000000000178. | |
| 22310867 | Background | Lee J, Han M, Chung Y, Kim J, Choi J. Effects of foot reflexology on fatigue, sleep and pain: a systematic review and meta-analysis. J Korean Acad Nurs. 2011 Dec;41(6):821-33. doi: 10.4040/jkan.2011.41.6.821. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| D012893 | Sleep Wake Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Two-arm parallel randomized controlled trial comparing conventional physical therapy alone versus conventional physical therapy combined with foot reflexology in female patients with fibromyalgia.
Not provided
Not provided
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.
| Conventional Physical Therapy | Other | 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. |
|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Device | High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants. |
|
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. |
| Baseline and 6 weeks |
| 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. | Baseline and 6 weeks |
| 27916278 | Background | Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30. |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |