- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694999
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kaleem Ullah, Master
- Phone Number: +92 341 7675683
- Email: ukaleem618@gmail.com
Study Contact Backup
- Name: Dr Zahid Mehmood, Master
- Phone Number: 03004615611
- Email: zahidmehmood8754@gmail.com
Study Locations
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Khyber Pakhtunkhwa
-
Peshawar, Khyber Pakhtunkhwa, Pakistan
- Recruiting
- Shahab Orthopedic and General Hospital
-
Contact:
- Kaleem Ullah, MS
- Phone Number: +92 341 7675683
- Email: ukaleem618@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Measured by the Visual Analogue Scale (VAS)
Time Frame: 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.
|
Baseline and at the end of the 2-week intervention period
|
|
Foot Function Measured by the Foot Function Index (FFI)
Time Frame: 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.
|
Baseline and at the end of the 2-week intervention period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr Zahid Mehmood, Ibadat International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ref: IIUI/RERC/ADT/2026/02/258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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