Effect of Radiofrequency Treatment in Plantar Fasciitis Patients

Recruiting

• Conditions: Fasciitis, Plantar
• Interventions: Procedure: posterior tibial nerve radiofrequency; Procedure: plantar fasciitis radiofrequency

• Registration Number: NCT06426667
• Lead Sponsor: Ankara University

Brief Summary

In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Numerous randomized and non-randomized studies have demonstrated the effectiveness of radiofrequency as a treatment modality for chronic plantar heel pain.In this study, our objective is to assess the impact of radiofrequency modalities applied to the posterior tibial nerve and/or the calcaneal spur area, guided by ultrasound, on patient satisfaction, pain scores, and functional improvement in individuals with chronic plantar fasciitis

Detailed Description

Chronic plantar fasciitis is the most common cause of chronic heel pain in adults. Typically, patients describe a throbbing pain localized around the origin of the plantar fascia on the calcaneus. This pain is often most severe when taking the first steps in the morning or rising after sitting. It typically improves with activity but worsens with prolonged activity. The primary aim of heel spur treatment is to alleviate pain and restore function. Surgical interventions are recommended for chronic plantar heel pain resistant to conservative options. However, surgery may be associated with prolonged recovery, and in one study, superiority over conservative treatment was not demonstrated. Radiofrequency has been shown to be an effective treatment method for chronic plantar heel pain in many randomized and non-randomized studies. In many studies, most of these procedures are applied blindly based on anatomical landmarks, with attention drawn in many studies to applications targeting the terminal branches of the posterior tibial nerve or the spur region. Only a few studies have been performed using fluoroscopy and ultrasound guidance. Ultrasound guidance offers several advantages over fluoroscopy and blind landmark techniques, especially in interventional procedures targeting neural and soft tissues. These advantages include the ability to visualize vascular and neural structures, very low risk of vascular-neural injury, absence of radiation exposure, and superiority in cases of anatomical variation. However, a common point in many studies related to plantar fasciitis is that applications are either directed to the spur area or to neural structures leading to the heel region. In this study, we aim to compare the effects of radiofrequency modalities applied to the posterior tibial nerve and/or calcaneal spur area under ultrasound guidance on patient satisfaction, pain scores, and patient functionality in cases of chronic plantar fasciitis (heel spur).

Study Timeline

• Study Start: 2024-04-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-18
• Study First Submitted QC: 2024-05-18
• Study First Posted: 2024-05-23
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• 18-65 years old,
• Heel pain for at least 6 months and a diagnosis of plantar fasciitis confirmed by direct radiography and physical examination,
• Visual analog scale is 4 or more
• No response to conservative treatment (medical and physical medicine modalities)

Exclusion Criteria

• History of trauma or calcaneus fracture,
• Osteoarthritis, Diabetes mellitus, chronic heart disease
• Presence of pregnancy,
• Pain due to peripheral neuropathy or ischemia
• Inability to tolerate injections in the heel area,
• Allergy to local anesthetics or steroids,
• Presence of an open wound on the side of the foot that the injection will be performed
• Local or systemic infection at the time of the procedure
• Previous steroid injection, radiofrequency application or ESWT (electroshock wave) treatment into the heel
• History of surgical intervention to the heel
• Presence of any functional limitation in the affected foot
• Presence of neurological, hepatic and/or metabolic diseases; dermatological infections, seronegative spondyloarthropathy, bleeding diathesis
• Failure to discontinue anticoagulant or antiaggregant within the specified periods
• Absence of follow-up throughout the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
posterior tibial nerve radiofrequency	posterior tibial nerve radiofrequency	posterior tibial nerve pulsed radiofrequency treatment
plantar fasciitis radiofrequency	plantar fasciitis radiofrequency	calcaneal spur thermocoagulation radiofrequency treatment
posterior tibial nerve and plantar fasciitis radiofrequency	plantar fasciitis radiofrequency	posterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment
posterior tibial nerve and plantar fasciitis radiofrequency	posterior tibial nerve radiofrequency	posterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment

Primary Outcome Measures

Name	Time	Method
Patient satisfaction after the procedure	1 and 3 months	Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied".
medication use	1 and 3 months	number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated
pain severity	1 and 3 months	pain severity change by using Numeric Rating Scala will be observed before and at 1, 3 months after the procedure.; pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.The 11-point numerical scale ranges from '0', representing "no pain", to '10', representing extreme pain (e.g., "pain as bad as you can imagine" or "worst pain imaginable").
functionallity	1 and 3 months	Functionality of foot will be observed at before the procedure and 1, 3 months after the procedure. Foot functionalliy index will be used. Foot function index consists of 23 items with 3 subgroups: pain, disability and activity limitation. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation. The survey score varies between 0-100, and as the score increases, the disability increases.

Trial Locations

Locations (1)

Ankara University; 🇹🇷 Ankara, Turkey