Pulsed Radiofrequency Versus 5% Dextrose Injection in Chronic Plantar Fasciitis

NCT07688876 | Recruiting

• 1 other identifier: E2-26-14591
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, two-center, randomized controlled clinical trial aims to compare the effectiveness of ultrasound-guided pulsed radiofrequency and 5% dextrose injection in patients with chronic plantar fasciitis. Eligible participants will be randomized into two parallel groups. One group will receive ultrasound-guided pulsed radiofrequency treatment, and the other group will receive ultrasound-guided 5% dextrose injection using the peppering technique. All participants will receive a home-based plantar fascia stretching exercise program. Outcomes will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks after treatment. The primary outcome will be pain intensity measured by the Numeric Rating Scale. Secondary outcomes will include foot function, activity-related pain, ankle-hindfoot function, and health-related quality of life.

Conditions

Chronic Plantar Fasciitis; Chronic Heel Pain; Foot Pain

Keywords

Pulsed radiofrequency; Radiofrequency treatment; Dextrose injection; Prolotherapy; Ultrasound-guided injection; Plantar fascia; Chronic heel pain; Numeric Rating Scale; Foot Function Index; AOFAS score; Nottingham Health Profile

Outcome Measures

Primary Outcomes (1)

• Change in Heel Pain Intensity Assessed by Numeric Rating Scale

  Heel pain intensity will be assessed using the Numeric Rating Scale. Resting pain, pain during plantar fascia stretching, and pain with pressure will be evaluated on an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

  Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

Secondary Outcomes (4)

• Change in Activity-Related Pain Assessed by the Roles and Maudsley Score

  Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

• Change in Foot Function Assessed by the Foot Function Index

  Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

• Change in Ankle-Hindfoot Function Assessed by the American Orthopaedic Foot and Ankle Society Score

  Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

• Change in Health-Related Quality of Life Assessed by the Nottingham Health Profile

  Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

Study Arms (2)

Ultrasound-Guided Pulsed Radiofrequency Treatment

EXPERIMENTAL

Participants in this group will receive ultrasound-guided pulsed radiofrequency treatment at baseline. Clinical follow-up assessments will be performed at 3 weeks, 6 weeks, and 12 weeks. All participants will also receive a home-based plantar fascia stretching exercise program.

Procedure: Ultrasound-Guided Pulsed Radiofrequency Treatment

Ultrasound-Guided 5% Dextrose Injection

ACTIVE COMPARATOR

Ultrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis. Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications.

Procedure: Ultrasound-Guided 5% Dextrose Injection

Interventions

Ultrasound-Guided Pulsed Radiofrequency Treatment PROCEDURE

Ultrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis. Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications.

Ultrasound-Guided Pulsed Radiofrequency Treatment

Ultrasound-Guided 5% Dextrose Injection PROCEDURE

Ultrasound-guided 5% dextrose injection will be applied around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2 mL administered at each entry point. The treatment will consist of three sessions performed at 3-week intervals.

Ultrasound-Guided 5% Dextrose Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic plantar fasciitis based on medical history and physical examination
• Heel pain resistant to conservative treatment for at least 12 weeks
• Age between 18 and 70 years
• Willingness to participate in the study and provide written informed consent

You may not qualify if:

• Congenital or acquired disease that may impair or prevent foot function, such as rheumatoid arthritis, hemiplegia, congenital foot deformity, traumatic foot or leg amputation, or fracture sequelae
• Local infection or skin disease at the treatment site
• Bleeding disorder or use of anticoagulant medication within the last week
• Disease causing mental dysfunction, such as uncontrolled Parkinson disease or Alzheimer disease
• Previous surgery for plantar fasciitis
• Refusal to participate in the study or inability to provide informed consent
• Failure to attend follow-up visits after treatment
• Request to withdraw from the study
• Pregnancy or suspected pregnancy
• Presence of a cardiac pacemaker
• History of epilepsy
• Active or previous malignancy
• Rheumatologic disease

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Glucose

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Esra Ülgen Kıratlıoğlu, MD

CONTACT

+905079614194; esraulgen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to treatment allocation. Blinding of the interventionists will not be possible due to the nature of the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomized into two parallel groups: ultrasound-guided pulsed radiofrequency treatment and ultrasound-guided 5% dextrose injection.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)