Pulsed Radiofrequency Versus 5% Dextrose Injection in Chronic Plantar Fasciitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAnkara City Hospital Bilkent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-Guided Pulsed Radiofrequency Treatment
Procedure/SurgeryUltrasound-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 5% Dextrose Injection
Procedure/SurgeryUltrasound-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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ultrasound-Guided Pulsed Radiofrequency TreatmentExperimental treatment 1 intervention
Group B: Ultrasound-Guided 5% Dextrose InjectionActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatmentSecondary outcomes
1
Change in Activity-Related Pain Assessed by the Roles and Maudsley Score
Activity-related heel pain and functional status will be assessed using the Roles and Maudsley Score. The score ranges from 1 to 4, with lower scores indicating better clinical status and higher scores indicating worse pain and functional limitation.
Time frame
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment2
Change in Foot Function Assessed by the Foot Function Index
Foot-related pain, disability, and activity limitation will be assessed using the Foot Function Index. The scale includes pain, disability, and activity limitation subscales. Scores are converted to a 0-100 scale, with higher scores indicating greater pain, disability, and activity limitation.
Time frame
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment3
Change in Ankle-Hindfoot Function Assessed by the American Orthopaedic Foot and Ankle Society Score
Ankle-hindfoot function will be assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score. The score evaluates pain, function, and alignment. The total score ranges from 0 to 100, with higher scores indicating better ankle-hindfoot function.
Time frame
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment4
Change in Health-Related Quality of Life Assessed by the Nottingham Health Profile
Health-related quality of life will be assessed using the Nottingham Health Profile. The questionnaire includes six domains: energy level, pain, emotional reactions, sleep, social isolation, and physical activity. The total score ranges from 0 to 600, with higher scores indicating worse perceived health status.
Time frame
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatmentSponsors and contacts
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Source ClinicalTrials.gov