Ice Packs Versus Cold Baths Combined With Standard Exercise Therapy for Plantar Fasciitis

Официальное название

Comparative Efficacy of Ice Packs Versus Cold Baths With Standard Exercise Therapy in the Management of Plantar Fasciitis

Обзор

This randomized controlled trial aims to compare the effectiveness of ice pack therapy and cold bath immersion when combined with standard exercise therapy in adults with plantar fasciitis. Plantar fasciitis is a common cause of heel pain that can limit daily activities and reduce quality of life. Participants will be randomly assigned to receive either ice pack therapy or cold bath therapy in addition to the same standardized exercise program. The primary outcome will be pain intensity measured using the Visual Analogue Scale (VAS), and the secondary outcome will be foot function measured using the Foot Function Index (FFI). The findings of this study may help identify the more effective cryotherapy method for reducing pain and improving function in individuals with plantar fasciitis.

Подробное описание

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.

Вмешательства

• Процедура Ice Pack Therapy
  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.
• Процедура Cold Water Immersion
  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.
• Процедура Standard Exercise Therapy
  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.

Первичные конечные точки

• Pain Intensity Measured by the Visual Analogue Scale (VAS) [Срок оценки: Baseline and at the end of the 2-week intervention period]
• Foot Function Measured by the Foot Function Index (FFI) [Срок оценки: Baseline and at the end of the 2-week intervention period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Shahab Orthopedic and General Hospital — Peshawar

Идентификаторы

NCT: NCT07694999 · Ref: IIUI/RERC/ADT/2026/02/258

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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