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

NCT07694999 | Recruiting DMC

• 1 other identifier: Ref: IIUI/RERC/ADT/2026/02/258
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fasciitis

Keywords

Ice Pack; Cold Bath; Foot Function Index; Visual Analogue Scale

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (2)

Ice Pack + Standard Exercise Therapy

EXPERIMENTAL

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.

Procedure: Ice Pack Therapy; Procedure: Standard Exercise Therapy

Cold Bath + Standard Exercise Therapy

EXPERIMENTAL

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.

Procedure: Cold Water Immersion; Procedure: Standard Exercise Therapy

Interventions

Ice Pack Therapy PROCEDURE

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.

Ice Pack + Standard Exercise Therapy

Cold Water Immersion PROCEDURE

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.

Cold Bath + Standard Exercise Therapy

Standard Exercise Therapy PROCEDURE

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 Bath + Standard Exercise Therapy; Ice Pack + Standard Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ibadat International University, Islamabad: lead

Study Sites (1)

Shahab Orthopedic and General Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Dr Zahid Mehmood

  Ibadat International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaleem Ullah, Master

CONTACT

+92 341 7675683; ukaleem618@gmail.com

Dr Zahid Mehmood, Master

CONTACT

03004615611; zahidmehmood8754@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel intervention groups. Group A will receive ice pack therapy combined with standard exercise therapy, while Group B will receive cold bath immersion combined with the same standard exercise therapy. Participants will remain in their assigned group throughout the study, and outcomes will be compared between groups.

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: February 17, 2026
• Primary Completion: July 6, 2026
• Study Completion: July 7, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)