Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

NCT07233395 | Not Yet Recruiting

• 1 other identifier: KanuniSSTRH-PF-2025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 . 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.

Conditions

Plantar Fasciitis

Keywords

Dextrose Prolotherapy; Extracorporeal Shock Wave Therapy (ESWT); Physical Medicine and Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (2)

• Change in Foot Function Index (FFI) Total Score

  Baseline, 6 weeks, 12 weeks

• Change in Roles and Maudsley Score

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

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.

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.

Device: Extracorporeal Shock Wave Therapy (ESWT)

Interventions

Dextrose Prolotherapy PROCEDURE

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.

Also known as: Prolotherapy Injection

Dextrose Prolotherapy

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

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.

Also known as: Shock Wave Therapy

Extracorporeal Shock Wave Therapy (ESWT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Prolotherapy; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Physical Therapy Modalities; Rehabilitation

Study Officials

• ZEYNEP KARAKUZU GÜNGÖR, MD

  Kanuni Sultan Süleyman Training and Research Hospital, Istanbul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZEYNEP KARAKUZU GÜNGÖR

CONTACT

+905077750375; zeynepkarakuzu@hotmail.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to treatment allocation. Participants and care providers will be aware of the intervention due to the nature of the treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: March 15, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share