Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia (REFLEX-FM)
3. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ghada M Mohamed El-Hady Ismaeil, BSc, PT
- Telefonnummer: +201005677669
- E-post: 10722018823327@pg.cu.edu.eg
Studiesteder
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypt, 35744
- Rekruttering
- Dekernis General Hospital
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Ta kontakt med:
- Ghada M Mohamed El-Hady Ismaeil, BSc, PT
- Telefonnummer: +201005677669
- E-post: 10722018823327@pg.cu.edu.eg
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Hovedetterforsker:
- Ghada M Mohamed El-Hady Ismaeil, BSc, PT
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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.
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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.
High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
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Eksperimentell: 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.
|
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.
High-frequency TENS will be administered twice weekly for six weeks using conventional settings for pain management in fibromyalgia participants.
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pressure Pain Threshold (PPT)
Tidsramme: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Fibromyalgia Symptom Impact (FIQ-A)
Tidsramme: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sleep Quality (PSQI-A)
Tidsramme: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Psychological Distress (HADS)
Tidsramme: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Functional Activity and Health-Related Quality of Life (SF-36v2)
Tidsramme: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
3. juni 2026
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
31. oktober 2026
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Muskel- og skjelettsykdommer
- Sykdommer i nervesystemet
- Muskelsykdommer
- Psykiske lidelser
- Nevromuskulære sykdommer
- Revmatiske sykdommer
- Nevroatferdsmanifestasjoner
- Perseptuelle forstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Fibromyalgi
- Kronisk smerte
- Søvnvåkenforstyrrelser
- Agnosia
- Terapeutikk
- Fysioterapi -modaliteter
- Rehabilitering
- Anestesi og smertestillende
- Elektrisk stimuleringsbehandling
- Analgesi
- Transkutan elektrisk nervestimulering
Andre studie-ID-numre
- FPT-CU-REFLEX-FM-2026
- P.T.REC/012/006040 (Annen identifikator: Research Ethical Committee, Faculty of Physical Therapy, Cairo University)
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