Plantar FasciitisNCT07694999
Ice Packs Versus Cold Baths Combined With Standard Exercise Therapy for Plantar Fasciitis
A study testing Ice Pack Therapy, Cold Water Immersion and Standard Exercise Therapy in people with Plantar Fasciitis, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Ice Pack Therapy, Cold Water Immersion and Standard Exercise Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Feb 2026to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shahab Orthopedic and General Hospital
Peshawar, Khyber Pakhtunkhwa
Kaleem Ullah, MS, +92 341 7675683, ukaleem618@gmail.com
About this study
Official title: Comparative Efficacy of Ice Packs Versus Cold Baths With Standard Exercise Therapy in the Management of Plantar Fasciitis
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Ice Pack Therapy, Cold Water Immersion, Standard Exercise Therapy
- Keywords
- Ice Pack, Cold Bath, Foot Function Index, Visual Analogue Scale
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice Pack TherapyProcedure or 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 ImmersionProcedure or 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 TherapyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Cold Water Immersion; Procedure: Standard Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and at the end of the 2-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start17 Feb 2026
- Primary completion6 Jul 2026 (estimated)
- Study completion7 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Zahid Mehmood, Principal investigator, Ibadat International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694999
- Sponsor's protocol ID
- Ref: IIUI/RERC/ADT/2026/02/258
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available because the study is an investigator-initiated academic research project, and participant confidentiality and privacy will be protected in accordance with institutional ethical requirements. De-identified aggregate data will be reported in publications and presentations. Requests for additional study information may be considered by the principal investigator and the institutional ethics committee, subject to applicable ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Ice Packs Versus Cold Baths With Standard Exercise Therapy in the Management of Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07694999
- Acronym / sponsor ID
- Ref: IIUI/RERC/ADT/2026/02/258
- Conditions
- Plantar Fasciitis
- Keywords
- Ice Pack, Cold Bath, Foot Function Index, Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 6 Jul 2026 (estimated)
- Study completion
- 7 Jul 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ice Pack + Standard Exercise Therapy | Experimental | Procedure: Ice Pack Therapy, Procedure: Standard Exercise TherapyParticipants 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. |
| Cold Bath + Standard Exercise Therapy | Experimental | Procedure: Cold Water Immersion, Procedure: Standard Exercise TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice Pack TherapyIce 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. | Procedure or surgery | Ice Pack + Standard Exercise Therapy |
| Cold Water ImmersionCold 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. | Procedure or surgery | Cold Bath + Standard Exercise Therapy |
| Standard Exercise TherapyAll 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. | Procedure or surgery | Cold Bath + Standard Exercise Therapy, Ice Pack + Standard Exercise Therapy |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because the study is an investigator-initiated academic research project, and participant confidentiality and privacy will be protected in accordance with institutional ethical requirements. De-identified aggregate data will be reported in publications and presentations. Requests for additional study information may be considered by the principal investigator and the institutional ethics committee, subject to applicable ethical and regulatory requirements.
Related trials for Plantar Fasciitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Recruiting
Extracorporeal Shock Wave Therapy With or Without Kinesiotaping for Plantar Fasciitis
Plantar Fasciitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Zahid Mehmood principal investigator
Ibadat International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice Pack Therapy, Cold Water Immersion and Standard Exercise Therapy in people with Plantar Fasciitis, run by Ibadat International University, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaleem Ullah, Master (+92 341 7675683, ukaleem618@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured by the Visual Analogue Scale (VAS) (time frame: Baseline and at the end of the 2-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.