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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIbadat International University, Islamabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ice Pack Therapy

    Procedure/Surgery

    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.

  • Cold Water Immersion

    Procedure/Surgery

    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.

  • Standard Exercise Therapy

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Ice Pack + Standard Exercise TherapyExperimental treatment 2 interventions
Group B: Cold Bath + Standard Exercise TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain Intensity Measured by the Visual Analogue Scale (VAS)

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.

Time frame
Baseline and at the end of the 2-week intervention period
2

Foot Function Measured by the Foot Function Index (FFI)

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.

Time frame
Baseline and at the end of the 2-week intervention period

Secondary outcomes

Other outcomes

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