Efficacy of Pulse Radiofrequency Treatment in Patients With Coxarthrosis

February 6, 2024 updated by: Fatıma Korkmaz, Ankara City Hospital Bilkent

The Efficacy of Pulse Radiofrequency Treatment to Articular Branches of Femoral and Obturator Nerves in Patients With Coxarthrosis

Our aim in this interventional study is to investigate the effectiveness of pulsed radiofrequency (PRF) treatment applied to the articular branches of the femoral and obturator nerves on pain, functional level, functional capacity and quality of life in patients with coxarthrosis. We will compare the effects of PRF treatment added to nerve block compared to nerve block alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip pain caused by coxarthrosis is common in the general population and is one of the leading causes of disability in the aging population. Conservative treatments may fail due to side effects or ineffectiveness. Surgery is generally recommended for patients who do not respond to conservative treatment. Surgery is not always an appropriate option for elderly patients and patients with multiple comorbidities. For this reason, nerve block may be an appropriate treatment option for patients who do not respond to conservative treatment, who are not suitable for surgery or who do not want surgery. Pulsed radiofrequency (PRF) is a method of temporarily preventing pain transmission through heat increase in the tissue with the help of an electrode placed near the target nerve. Most of the pain sensation in the hip joint is received by the articular branches of the femoral and obturator nerves. The application of PRF to the nerves innervating the hip joint may be an effective method to reduce pain and disability in these patients.

This study was designed as a prospective, randomized, controlled trial. According to the statistical analysis, 28 patients who met the eligibility criteria were planned to be included in the study. The patients will be divided into 2 groups as the block group (n=14) and the PRF group (n=14). In procedures performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. Nerve block and PRF procedures will be performed in sterile conditions according to their protocols. Patients will be evaluated about pain, functional level, functional capacity and quality of life before treatment, at week 2, week 4, and week 12. If complications develop, they will be recorded.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with unilateral and/or bilateral hip pain for more than 6 months who meet the diagnosis of coxarthrosis according to the American College of Rheumatology(ACR) criteria
  • Pain intensity greater than 3 according to the visual analog pain scale
  • Stage ≥2 hip osteoarthritis according to the Kellgren-Lawrence classification
  • Ambulation with or without support
  • Having the mental competence to express pain scores
  • Signing an informed consent form stating consent to participate in the study

Exclusion Criteria:

  • Other non-degenerative causes of hip pain (Avascular necrosis, femoraacetebular impingement syndrome, thoracenteric bursitis)
  • Concomitant central nervous system and/or peripheral nervous system disease
  • History of lower extremity fracture/surgery in the last 6 months
  • Local infection on the hip or presence of systemic infection
  • Conditions where fluoroscopy-guided injection is contraindicated like pregnancy, contrast material allergy, local anesthetic allergy, coagulopathy
  • Presence of unstable systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulse Radiofrequency Group
Pulse radiofrequency therapy will be applied to each nerve in 2 cycles of 120 seconds for patients in the pulse radiofrequency group. After the pulse radiofrequency procedure, 1 cc betamethasone and 1 cc 1% lidocaine will be injected for each nerve.
Device: Pulse radiofrequency treatment
In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, pulse radiofrequency will be applied to each nerve in 2 cycles of 120 seconds for the patients in this group. The pulse radiofrequency current will be 20 milliseconds wide and 45 volts in size. The tip temperature shall not be more than 42℃.
Drug: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine
In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, patients will be injected with 1 cc betamethasone and 1 cc 1% lidocaine for each nerve. A total of 2 cc volume will be injected for each nerve.
Active Comparator: Block Group
For the patients in the block group, nerve block will be performed by applying 1 cc betamethasone and 1 cc 1% lidocaine for each nerve.
Drug: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine
In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, patients will be injected with 1 cc betamethasone and 1 cc 1% lidocaine for each nerve. A total of 2 cc volume will be injected for each nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: baseline, week 2, week 4 and week 12
Visual Analogue Scale (VAS) is one of the pain rating scales. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (extreme pain). At rest, with movement, nighttime VAS scores and averages of them will be recorded.
baseline, week 2, week 4 and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Range of Motion
Time Frame: baseline, week 2, week 4 and week 12
Active ROM is a joint movement that can be achieved by active muscle contraction without the aid of external forces. It will be measured with a goniometer by physician.
baseline, week 2, week 4 and week 12
Passive Range of Motion
Time Frame: baseline, week 2, week 4 and week 12
Passive ROM is joint motion that can be achieved with the help of external forces. It will be measured with a goniometer by physician.
baseline, week 2, week 4 and week 12
Harris Hip Score (HHS)
Time Frame: baseline, week 2, week 4 and week 12
HHS is a measure of dysfunction for the hip joint. It consists of 4 parts including pain, function, absence of deformity and range of motion. Scores range from 0 to 100. Higher scores mean less dysfunction.
baseline, week 2, week 4 and week 12
Six Minute Walk Test
Time Frame: baseline, week 2, week 4 and week 12
6-minute walk test is used to measure the functional capacity of the person. A 30-meter-long, flat and hard-floored walking path is used. The start and end points are marked with cones. The distance that walked over 6 minutes will be recorded. Higher distance indicates better functional capacity.
baseline, week 2, week 4 and week 12
Short From-36 (SF-36)
Time Frame: baseline, week 2, week 4 and week 12
Sf-36 is a questionare that measure health related quality of life. It includes 36 questions and assesses 8 health domains: physical functionality, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health perceptions. Scores for each domain range from 0 to 100. A higher score identifies a better state of health.
baseline, week 2, week 4 and week 12
Number of analgesics
Time Frame: baseline, week 2, week 4 and week 12
The number of analgesic drugs used daily by the patient is recorded.
baseline, week 2, week 4 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

November 25, 2023

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-FTR-FK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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