Effect of Radiofrequency Treatment in Plantar Fasciitis Patients

NCT06426667 | Completed

• 1 other identifier: 2024/202
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Fasciitis, Plantar

Keywords

Fasciitis, Plantar; Radiofrequency Therapy

Outcome Measures

Primary Outcomes (4)

• pain severity

  pain severity change by using Numeric Rating Scala will be observed before and at 1 week, 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").

  1 and 3 months

• Patient satisfaction after the procedure

  Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied".

  1 and 3 months

• functionallity

  Functionality of foot will be observed at before the procedure and 1 week, 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.

  1 and 3 months

• medication use

  number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated

  1 and 3 months

Study Arms (3)

posterior tibial nerve radiofrequency

posterior tibial nerve pulsed radiofrequency treatment

Procedure: posterior tibial nerve radiofrequency

plantar fasciitis radiofrequency

calcaneal spur thermocoagulation radiofrequency treatment

Procedure: plantar fasciitis radiofrequency

posterior tibial nerve and plantar fasciitis radiofrequency

posterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment

Procedure: posterior tibial nerve radiofrequency; Procedure: plantar fasciitis radiofrequency

Interventions

posterior tibial nerve radiofrequency PROCEDURE

pulse radiofrequency at 45 V for 300 seconds at 42 degrees Celsius is applied to the posterior tibial nerve area. During the procedure, the temperature at the electrode tip is kept below 42°C. Following negative aspiration (in the absence of blood), 2 cc of 1% lidocaine + 4 mg dexamethasone is applied to the same area.

posterior tibial nerve and plantar fasciitis radiofrequency; posterior tibial nerve radiofrequency

plantar fasciitis radiofrequency PROCEDURE

the spur area on the calcaneal bone is identified, and sensory and motor stimulations are applied using the RF cannula. If no sensory or motor response is elicited in the area, conventional radiofrequency at 45 V for 60 seconds at 80 degrees Celsius is applied to the spur area after confirming the placement of the RF cannula.

plantar fasciitis radiofrequency; posterior tibial nerve and plantar fasciitis radiofrequency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 18 and 65 who are scheduled to receive radiofrequency tretament due to plantar fasciitis will be included in the study.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (4)

• Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan.

  PMID: 35097359 BACKGROUND

• Li X, Zhang L, Gu S, Sun J, Qin Z, Yue J, Zhong Y, Ding N, Gao R. Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 Oct;97(43):e12819. doi: 10.1097/MD.0000000000012819.

  PMID: 30412072 BACKGROUND

• Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14.

  PMID: 28209507 BACKGROUND

• Orhurhu V, Urits I, Orman S, Viswanath O, Abd-Elsayed A. A Systematic Review of Radiofrequency Treatment of the Ankle for the Management of Chronic Foot and Ankle Pain. Curr Pain Headache Rep. 2019 Jan 19;23(1):4. doi: 10.1007/s11916-019-0745-5.

  PMID: 30661127 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Hanzade A Unal, MD

  Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 23, 2024
• Study Start: April 15, 2024
• Primary Completion: July 30, 2024
• Study Completion: November 30, 2024
• Last Updated: June 13, 2025

Record last verified: 2024-05

Locations

TU (1)