Ice Packs Versus Cold Baths Combined With Standard Exercise Therapy for Plantar Fasciitis
Comparative Efficacy of Ice Packs Versus Cold Baths With Standard Exercise Therapy in the Management of Plantar Fasciitis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Plantar fasciitis is one of the most common causes of plantar heel pain and is associated with functional limitations, reduced mobility, and impaired quality of life. Conservative management is considered the first-line treatment and typically includes therapeutic exercises, stretching, strengthening, patient education, and cryotherapy. Although cryotherapy is widely used to relieve pain and reduce tissue inflammation, there is limited evidence comparing the effectiveness of different cryotherapy modalities in patients with plantar fasciitis.
This study is a prospective, parallel-group, randomized controlled trial designed to compare the clinical effectiveness of ice pack application and cold bath immersion when both are combined with a standardized exercise therapy program.
Eligible adults diagnosed with plantar fasciitis will be randomly allocated into one of two intervention groups:
Group A: Ice pack therapy combined with standard exercise therapy. Group B: Cold bath immersion combined with standard exercise therapy.
Both groups will receive identical exercise therapy consisting of plantar fascia stretching, calf muscle stretching, eccentric heel raises, and balance training. Cryotherapy will be administered for 10 minutes per session, five sessions per week, for two weeks.
The primary outcome will be pain intensity measured using the Visual Analogue Scale (VAS). The secondary outcome will be functional disability measured using the Foot Function Index (FFI). Outcome assessments will be performed at baseline and immediately after completion of the two-week intervention period.
The study hypothesizes that one cryotherapy modality may provide superior pain relief and functional improvement when combined with standard exercise therapy. The results are expected to provide evidence for selecting the most effective, low-cost, and easily applicable cryotherapy intervention for conservative management of plantar fasciitis and may contribute to evidence-based physiotherapy practice.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kaleem Ullah, Master
- Número de teléfono: +92 341 7675683
- Correo electrónico: ukaleem618@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Dr Zahid Mehmood, Master
- Número de teléfono: 03004615611
- Correo electrónico: zahidmehmood8754@gmail.com
Ubicaciones de estudio
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistán
- Reclutamiento
- Shahab Orthopedic and General Hospital
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Contacto:
- Kaleem Ullah, MS
- Número de teléfono: +92 341 7675683
- Correo electrónico: ukaleem618@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 to 65 years.
- Clinical diagnosis of unilateral or bilateral Plantar Fasciitis.
- Heel pain localized to the medial calcaneal tubercle.
- Positive Windlass test.
- Pain intensity of ≥4 on the Visual Analogue Scale (VAS) at baseline.
- Willing and able to provide written informed consent.
- Willing to comply with the study protocol and attend all treatment and assessment sessions.
Exclusion Criteria:
- History of foot or ankle surgery within the previous 6 months.
- Corticosteroid injection for plantar fasciitis within the previous month.
- Neurological disorders affecting the lower limb.
- Peripheral vascular disease or other vascular disorders affecting the lower limb.
- Open wounds, skin infections, or contraindications to cryotherapy.
- Pregnancy.
- Participation in another interventional clinical trial during the study period.
- Inability to follow the study protocol or complete outcome assessments.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Ice Pack + Standard Exercise Therapy
Participants assigned to this arm will receive ice pack therapy in combination with a standardized exercise therapy program.
Ice packs will be applied to the plantar aspect of the affected foot for 10 minutes per session, five sessions per week for two weeks.
The exercise program includes plantar fascia stretching, calf muscle stretching, eccentric heel raises, and balance training.
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Ice pack therapy will be administered by applying crushed ice or a commercial gel ice pack wrapped in a thin towel to the plantar aspect of the heel and medial longitudinal arch of the affected foot.
The intervention will be applied for 10 minutes per session, five sessions per week for two weeks.
Skin integrity will be assessed before and after treatment to minimize the risk of cold-related injury.
All participants will receive the same standardized exercise therapy program consisting of plantar fascia stretching, gastrocnemius and soleus stretching, eccentric heel raises, and balance training.
Supervised sessions will be conducted five times per week for two weeks, with participants instructed to continue home exercises on non-supervised days.
The exercise program is identical for both intervention groups.
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Experimental: Cold Bath + Standard Exercise Therapy
Participants assigned to this arm will receive cold bath immersion in combination with the same standardized exercise therapy program.
The affected foot will be immersed in cold water maintained at 10-15°C for 10 minutes per session, five sessions per week for two weeks.
The exercise program includes plantar fascia stretching, calf muscle stretching, eccentric heel raises, and balance training.
|
All participants will receive the same standardized exercise therapy program consisting of plantar fascia stretching, gastrocnemius and soleus stretching, eccentric heel raises, and balance training.
Supervised sessions will be conducted five times per week for two weeks, with participants instructed to continue home exercises on non-supervised days.
The exercise program is identical for both intervention groups.
Cold water immersion will be administered by immersing the affected foot up to the malleoli in water maintained at 10-15°C for 10 minutes per session, five sessions per week for two weeks.
Water temperature will be monitored before each treatment session, and participants will be observed for discomfort or excessive numbness throughout the intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity Measured by the Visual Analogue Scale (VAS)
Periodo de tiempo: Baseline and at the end of the 2-week intervention period
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Pain intensity will be assessed using the 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Participants will rate heel pain experienced during the first steps in the morning and during daily activities.
A reduction in the VAS score indicates improvement.
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Baseline and at the end of the 2-week intervention period
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Foot Function Measured by the Foot Function Index (FFI)
Periodo de tiempo: Baseline and at the end of the 2-week intervention period
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Functional status will be evaluated using the Foot Function Index (FFI), a validated questionnaire that measures pain, disability, and activity limitation associated with foot disorders.
Scores range from 0% to 100%, with lower scores indicating better foot function.
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Baseline and at the end of the 2-week intervention period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr Zahid Mehmood, Ibadat International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Ref: IIUI/RERC/ADT/2026/02/258
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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