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NCT Number: NCT07614945

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

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.

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Key information

Conditions

Fibromyalgia Agnosia Chronic Pain Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dekernis General Hospital

Al Mansurah, Dakahlia Governorate, 35744, Egypt

Location status: Recruiting

Location contact

Ghada M Mohamed El-Hady Ismaeil, BSc, PT

CONTACT

[email protected]

+201005677669

Ghada M Mohamed El-Hady Ismaeil, BSc, PT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pressure Pain Threshold (PPT)

    Time frame: 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.

  2. Fibromyalgia Symptom Impact (FIQ-A)

    Time frame: 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 outcomes

  1. Sleep Quality (PSQI-A)

    Time frame: 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.

  2. Psychological Distress (HADS)

    Time frame: 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.

  3. Functional Activity and Health-Related Quality of Life (SF-36v2)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada M Mohamed El-Hady Ismaeil, BSc, PT

CONTACT

[email protected]

+201005677669

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: REFLEX-FM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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