Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia (REFLEX-FM)

3 juni 2026 bijgewerkt door: Ghada Mahmoud Mohamed El-Hady Ismaeil, Cairo University

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Egypte
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypte, 35744
        • Werving
        • Dekernis General Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Ghada M Mohamed El-Hady Ismaeil, BSc, PT

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Control Group
Participants will receive conventional physical therapy including aerobic exercise, resistance training, stretching exercises, and transcutaneous electrical nerve stimulation (TENS) twice weekly for six weeks.
Ander: 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.
Apparaat: 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.
Experimenteel: Experimental Group
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.
Ander: 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.
Apparaat: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pressure Pain Threshold (PPT)
Tijdsspanne: 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.
Baseline and 6 weeks
Fibromyalgia Symptom Impact (FIQ-A)
Tijdsspanne: 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.
Baseline and 6 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sleep Quality (PSQI-A)
Tijdsspanne: 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.
Baseline and 6 weeks
Psychological Distress (HADS)
Tijdsspanne: 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.
Baseline and 6 weeks
Functional Activity and Health-Related Quality of Life (SF-36v2)
Tijdsspanne: 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.
Baseline and 6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Cairo University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

3 juni 2026

Primaire voltooiing (Geschat)

31 oktober 2026

Studie voltooiing (Geschat)

31 oktober 2026

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FPT-CU-REFLEX-FM-2026
  • P.T.REC/012/006040 (Andere identificatie: Research Ethical Committee, Faculty of Physical Therapy, Cairo University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren