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

NCT07614945 | Recruiting

• 2 other identifiers: FPT-CU-REFLEX-FM-2026P.T.REC/012/006040
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Reflexology; Foot Reflexology; Chronic Pain; Sleep Disorders; Physical Therapy; TENS; Fibromyalgia Syndrome; Pain Management; Women Health; Complementary Therapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Sleep Quality (PSQI-A)

  Baseline and 6 weeks

• Psychological Distress (HADS)

  Baseline and 6 weeks

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

  Baseline and 6 weeks

Study Arms (2)

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.

Other: Conventional Physical Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Behavioral: Foot Reflexology; Other: Conventional Physical Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

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.

Experimental Group

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.

Control Group; Experimental Group

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dekernis General Hospital

Al Mansurah, Dakahlia Governorate, 35744, Egypt

RECRUITING

Related Publications (3)

• 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 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.

  PMID: 22310867 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.

  PMID: 27916278 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Sleep Wake Disorders; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Ghada M Mohamed El-Hady Ismaeil, BSc, PT

CONTACT

+201005677669; 10722018823327@pg.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel randomized controlled trial comparing conventional physical therapy alone versus conventional physical therapy combined with foot reflexology in female patients with fibromyalgia.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

EG (1)