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

NCT ID: NCT07233395

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2026-03-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dextrose Prolotherapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Prolotherapy Injection; Shock Wave Therapy

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Karakuzu Güngör

Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ZEYNEP KARAKUZU GÜNGÖR, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Süleyman Training and Research Hospital, Istanbul

Central Contacts

ZEYNEP KARAKUZU GÜNGÖR

Role: CONTACT

zeynepkarakuzu@hotmail.com.tr

+905077750375

Other Identifiers

KanuniSSTRH-PF-2025

Identifier Type: -

Identifier Source: org_study_id