Plantar FasciitisNCT07233395
Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
A study testing Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in people with Plantar Fasciitis, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 15 Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of plantar fasciitis
- Ages 18 to 75 years
- Both male and female participants
- Heel pain localized to the medial calcaneal tubercle for more than 3 months
- Morning first-step pain and pain increasing with daily loading
- Willingness to participate and provide written informed consent
- Patients presenting to Kanuni Sultan Süleyman Training and Research Hospital
Who cannot join
- Cardiac pacemaker
- Type 1 or Type 2 diabetes mellitus
- History of inflammatory rheumatic disease
- Bleeding disorders
- Use of anticoagulant medications other than aspirin
- Allergy to dextrose
Show all 15Show fewer
- Previous foot or ankle surgery
- Peripheral neuropathy
- S1 radiculopathy in the same extremity
- Local corticosteroid injection to the plantar fascia within the last 3 months
- ESWT applied to the plantar fascia within the last 3 months
- Physical therapy applied to the foot/ankle in the last 3 months
- Cognitive dysfunction
- Active infection at the planned injection site
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.
Read the detailed description
Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.
- Conditions
- Plantar Fasciitis
- Being tested
- Dextrose Prolotherapy, Extracorporeal Shock Wave Therapy (ESWT)
- Keywords
- Dextrose Prolotherapy, Extracorporeal Shock Wave Therapy (ESWT), Physical Medicine and Rehabilitation
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose ProlotherapyProcedure or surgery
Also called Prolotherapy Injection
Participants in this group will receive dextrose prolotherapy twice, at two-week intervals.
A 5 mL syringe containing 2.5 mL of 30% dextrose, 2 mL isotonic saline, and 0.5 mL 2% lidocaine (final 15% dextrose solution) will be injected into seven points around the plantar fascia origin under aseptic conditions.
Extracorporeal Shock Wave Therapy (ESWT)Device
Also called Shock Wave Therapy
Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions.
The treatment will be applied to the plantar fascia insertion area using a standard clinical shock wave therapy device.
Energy level, frequency, and pulse count will be set according to manufacturer recommendations and standard clinical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose Prolotherapy | Experimental | Participants in this group will receive dextrose prolotherapy twice, at two-week intervals.
A 5 mL syringe will be prepared with 2.5 mL of 30% dextrose, 2 mL of isotonic saline, and 0.5 mL of 2% lidocaine (final 15% dextrose solution).
Injections will be administered into seven points around the plantar fascia origin and insertion under aseptic conditions. Receives: Procedure: Dextrose Prolotherapy |
| Extracorporeal Shock Wave Therapy (ESWT) | Active comparator | Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions.
The treatment will be applied to the plantar fascia insertion using a standard clinical ESWT device following manufacturer guidelines. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heel Pain Intensity (VAS Score)
Heel pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) at baseline, 6 weeks, and 12 weeks. The primary outcome is the change in VAS score from baseline to week 12 in each treatment group.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (2)
Change in Foot Function Index (FFI) Total Score
Functional status will be assessed using the Foot Function Index (FFI), which evaluates pain, disability, and activity limitation related to foot function. The total FFI score will be recorded at baseline, 6 weeks, and 12 weeks. The secondary outcome is the change in FFI total score over time.
Measured: Baseline, 6 weeks, 12 weeks
Change in Roles and Maudsley Score
The Roles and Maudsley functional pain score will be used to evaluate treatment response. Patients grade their condition on a 4-point scale from "excellent" to "poor." Scores will be obtained at baseline, 6 weeks, and 12 weeks. Improvement in score indicates better clinical outcome.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Mar 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 groups. One group will receive dextrose prolotherapy and the other will receive extracorporeal shock wave therapy (ESWT). The study aims to compare the effectiveness of these two regenerative treatment methods in patients with plantar fasciitis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- ZEYNEP KARAKUZU GÜNGÖR, MD, Principal investigator, Kanuni Sultan Süleyman Training and Research Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233395
- Sponsor's protocol ID
- KanuniSSTRH-PF-2025
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Data will only be accessible to the research team in accordance with institutional ethical guidelines and patient confidentiality regulations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07233395
- Acronym / sponsor ID
- KanuniSSTRH-PF-2025
- Conditions
- Plantar Fasciitis
- Keywords
- Dextrose Prolotherapy, Extracorporeal Shock Wave Therapy (ESWT), Physical Medicine and Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 18 Nov 2025 (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.
Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.
Detailed description
Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. One group will receive dextrose prolotherapy and the other will receive extracorporeal shock wave therapy (ESWT). The study aims to compare the effectiveness of these two regenerative treatment methods in patients with plantar fasciitis.
| Arm | Type | Receives |
|---|---|---|
| Dextrose Prolotherapy | Experimental | Procedure: Dextrose ProlotherapyParticipants in this group will receive dextrose prolotherapy twice, at two-week intervals. A 5 mL syringe will be prepared with 2.5 mL of 30% dextrose, 2 mL of isotonic saline, and 0.5 mL of 2% lidocaine (final 15% dextrose solution). Injections will be administered into seven points around the plantar fascia origin and insertion under aseptic conditions. |
| Extracorporeal Shock Wave Therapy (ESWT) | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT)Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions. The treatment will be applied to the plantar fascia insertion using a standard clinical ESWT device following manufacturer guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of plantar fasciitis
- Ages 18 to 75 years
- Both male and female participants
- Heel pain localized to the medial calcaneal tubercle for more than 3 months
- Morning first-step pain and pain increasing with daily loading
Key exclusion criteria (15 listed)
- Cardiac pacemaker
- Type 1 or Type 2 diabetes mellitus
- History of inflammatory rheumatic disease
- Bleeding disorders
- Use of anticoagulant medications other than aspirin
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 |
|---|---|---|
| Dextrose ProlotherapyAlso: Prolotherapy InjectionParticipants in this group will receive dextrose prolotherapy twice, at two-week intervals. A 5 mL syringe containing 2.5 mL of 30% dextrose, 2 mL isotonic saline, and 0.5 mL 2% lidocaine (final 15% dextrose solution) will be injected into seven points around the plantar fascia origin under aseptic conditions. | Procedure or surgery | Dextrose Prolotherapy |
| Extracorporeal Shock Wave Therapy (ESWT)Also: Shock Wave TherapyParticipants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions. The treatment will be applied to the plantar fascia insertion area using a standard clinical shock wave therapy device. Energy level, frequency, and pulse count will be set according to manufacturer recommendations and standard clinical protocols. | Device | Extracorporeal Shock Wave Therapy (ESWT) |
Primary outcome
Change in Heel Pain Intensity (VAS Score)
Time frame: Baseline, 6 weeks, 12 weeks
Heel pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) at baseline, 6 weeks, and 12 weeks. The primary outcome is the change in VAS score from baseline to week 12 in each treatment group.
2 secondary outcomes
Change in Foot Function Index (FFI) Total Score
Time frame: Baseline, 6 weeks, 12 weeks
Change in Roles and Maudsley Score
Time frame: Baseline, 6 weeks, 12 weeks
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 18 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Data will only be accessible to the research team in accordance with institutional ethical guidelines and patient confidentiality regulations.
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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.
ZEYNEP KARAKUZU GÜNGÖR, MD principal investigator
Kanuni Sultan Süleyman Training and Research Hospital, Istanbul
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in people with Plantar Fasciitis, run by Kanuni Sultan Suleyman Training and Research Hospital.
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 15 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: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 ZEYNEP KARAKUZU GÜNGÖR (+905077750375, zeynepkarakuzu@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heel Pain Intensity (VAS Score) (time frame: Baseline, 6 weeks, 12 weeks). 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 18 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.