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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Procedure: Dextrose Prolotherapy; Device: Extracorporeal Shock Wave Therapy (ESWT)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeynep Karakuzu Güngör; Phone Number: +905077750375; Email: zeynepkarakuzu@hotmail.com.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dextrose Prolotherapy; 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; 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.; Other Names: Prolotherapy Injection
Active Comparator: 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.	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 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.; Other Names: Shock Wave Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: ZEYNEP KARAKUZU GÜNGÖR, MD, Kanuni Sultan Süleyman Training and Research Hospital, Istanbul

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Physical Medicine and Rehabilitation; Dextrose Prolotherapy; Extracorporeal Shock Wave Therapy (ESWT)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy; Prolotherapy
• Other Study ID Numbers: KanuniSSTRH-PF-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No