Comparative Efficacy of Ice Packs Versus Cold Baths With Standard Exercise Therapy in the Management of Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain Intensity Measured by the Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study because participants and treating physiotherapists will be aware of the assigned intervention. Outcome assessments will be performed using standardized outcome measures (Visual Analogue Scale and Foot Function Index)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ice Pack Therapy (Procedure)
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.
干预措施: Standard Exercise Therapy (Procedure)
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.
干预措施: Cold Water Immersion (Procedure)
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.
干预措施: Standard Exercise Therapy (Procedure)
结局指标
主要结局
Pain Intensity Measured by the Visual Analogue Scale (VAS)
时间窗: Baseline and at the end of the 2-week intervention period
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.
Foot Function Measured by the Foot Function Index (FFI)
时间窗: Baseline and at the end of the 2-week intervention period
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.
次要结局
未报告次要终点