Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia (REFLEX-FM)
3 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ghada M Mohamed El-Hady Ismaeil, BSc, PT
- Número de teléfono: +201005677669
- Correo electrónico: 10722018823327@pg.cu.edu.eg
Ubicaciones de estudio
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egipto, 35744
- Reclutamiento
- Dekernis General Hospital
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Contacto:
- Ghada M Mohamed El-Hady Ismaeil, BSc, PT
- Número de teléfono: +201005677669
- Correo electrónico: 10722018823327@pg.cu.edu.eg
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Investigador principal:
- Ghada M Mohamed El-Hady Ismaeil, BSc, PT
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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.
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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.
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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pressure Pain Threshold (PPT)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep Quality (PSQI-A)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
3 de junio de 2026
Finalización primaria (Estimado)
31 de octubre de 2026
Finalización del estudio (Estimado)
31 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Desordenes mentales
- Enfermedades Neuromusculares
- Enfermedades reumáticas
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Fibromialgia
- Dolor crónico
- Trastornos del sueño y la vigilia
- Agnosia
- Terapéutica
- Modalidades de fisioterapia
- Rehabilitación
- Anestesia y analgesia
- Terapia de estimulación eléctrica
- Analgesia
- Estimulación del nervio eléctrico transcutáneo
Otros números de identificación del estudio
- FPT-CU-REFLEX-FM-2026
- P.T.REC/012/006040 (Otro identificador: Research Ethical Committee, Faculty of Physical Therapy, Cairo University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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