Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia

Official title

The Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia: A Randomized Controlled Trial

Overview

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

• Behavioral Foot 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.
• Other Conventional 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.
• Device Transcutaneous Electrical Nerve Stimulation (TENS)
  High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.

Primary outcome measures

• Pressure Pain Threshold (PPT) [Time frame: Baseline and 6 weeks]
• Fibromyalgia Symptom Impact (FIQ-A) [Time frame: Baseline and 6 weeks]

Secondary outcome measures (3)

• Sleep Quality (PSQI-A) [Time frame: Baseline and 6 weeks]
• Psychological Distress (HADS) [Time frame: Baseline and 6 weeks]
• Functional Activity and Health-Related Quality of Life (SF-36v2) [Time frame: Baseline and 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Dekernis General Hospital — Al Mansurah

Publications

• 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. PMID 27763930
• 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. PMID 22310867
• 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. PMID 27916278

Identifiers

NCT: NCT07614945 · FPT-CU-REFLEX-FM-2026 · P.T.REC/012/006040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗