Continuous Radiofrequency in Hip Osteoarthritis Pain: A Randomized Clinical Trial.

January 14, 2024 updated by: University of Brasilia

Continuous Radiofrequency in Hip Osteoarthritis Pain: A Protocol of a Randomized Clinical Trial

This will be a prospective, single-center, double-blinded, randomized study designed to compare the efficacy of the intraarticular injection of a corticosteroid and the Conventional Radiofrequency (CRF) of the anterior sensory branches to the hip in controlling pain and improving function related to hip osteoarthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Procedures will be performed in the surgical block of Hospital SARAH, Brasília unit, using an aseptic technique.

All participants will undergo sedation or general anesthesia using a laryngeal mask airway, according to the preference of the anesthetist in the room. The procedure will be performed with the participant positioned in dorsal decubitus, on a radiolucent table, with a small pillow below the knees to promote a slight flexion of 10 to 20 degrees of the hips, leading to relaxation of the joint capsule.

The surgeon will be positioned at the side of the surgical table, facing the affected hip, with the scoping device on the contralateral side, aligned at 90 degrees with the patient, allowing the visualization of anteroposterior images of the affected hip.

For the control group (IAI), a 22G spinal needle will be used, positioned in the anteroposterior direction towards the central portion of the femoral neck, which will be introduced until it trespasses the anterior hip capsule through tactile sensitivity. After verifying the correct positioning with the use of fluoroscopy and infusion of 3 milliliters (ml) of iodinated contrast diluted at 50% (Iomeron® 300, Patheon Italia S.p.A. Ferentino - Italy), an infiltration of 4 ml of 1% Ropivacaine (Ropi®, Cristália, Itapira - São Paulo, Brazil) and 80mg of methylprednisolone 40mg/ml (Predi-Medrol®, União Química, Brasília - Federal District, Brazil) will be performed, totalizing 6 ml of solution.

In the intervention group (IA + CRF), radiofrequency ablation will be performed with the aid of a 22-gauge cannula (Diros Technology Inc, Markham, Ontario, Canada), 10 or 15 cm long, with a 10-mm curved active tip, at a temperature of 90º for 90 seconds. The cannula will be introduced in the region just above the tip of the greater trochanter, lateral to a descending line originating in the anterior superior iliac spine (ASIS), and directed to the medial border of the patella (ASIS - patella). Its introduction will take place in the anteroposterior and lateromedial direction, to reach the region lateral to the anatomical reference known as the teardrop, with an angle of about 20 to 30 craniocaudal degrees about a transverse line on the axis of the thigh. The denervation of the articular branches of the Obturator Nerve (NO) will be performed in 2 cycles, at a temperature of 90 degrees for 90 seconds, starting lateral to the lateral edge of the obturator foramen and inferior to the teardrop, with subsequent repositioning of the cannula about 1 cm lateral to the first point. Both lesions will be preceded by motor stimulation at 2.5 volts (V) to exclude motor branches within the range of action of the active tip followed by the infusion of 2ml of 1% ropivacaine. Then, the cannula will be repositioned in a more cranial location, 2 to 3 cm lateral to the ASIS-patella line, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve (NF), performing three cycles (from medial to lateral) at the 01, 12, and 11 o'clock positions. The most medial lesion will be preceded by motor stimulation at 2.5 V to exclude motor branches within the active tip's range of action. All three cycles will be followed by 2 ml of 1% ropivacaine infusion. After completion of radiofrequency ablation, IAI of the hip will follow as described for the control group above.

Study Type

Interventional

Enrollment (Estimated)

70

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 Contact

Study Contact Backup

Study Locations

  • Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70335901
        • Recruiting
        • Rede Sarah Hospitais de Reabilitação
        • Contact:
        • Contact:
        • Principal Investigator:
          • João S Durigan, PhD

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:

  • Individuals ≥ 18 years of age, with symptomatic unilateral hip osteoarthritis, grades II and III according to the Kellgreen and Lawrance classification, hip pain for more than six months (medial, anterior, anterolateral, and/or lateral region) will be included.

Exclusion Criteria:

  • Individuals with radiculopathy and ipsilateral irradiation, osteonecrosis of the femoral head, previous arthroplasty on the hip to be studied or surgical scar that could lead to changes in the anatomy of the hip, cases of high dislocation of the hip, pain exclusively in the posterior region, symptomatic ipsilateral knee osteoarthritis, intra-articular infiltration of corticosteroids or hyaluronic acid in the hip for less than six months, patients with neurological diseases, peripheral neuropathy or psychiatric diseases, use of a pacemaker or Prothrombin Activity Time (INR) > 3.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
This group will be submitted to an intraarticular infiltration of corticosteroid + anesthetic.
Procedure: Intraarticular Infiltration ( Control group)
For the control group (IA), an epidural anesthesia needle (22G spinal needle) will be used, positioned anteroposteriorly towards the central portion of the femoral neck, which will be introduced until transfixion of the anterior hip capsule through tactile sensitivity. After checking the correct positioning with the use of fluoroscopy and infusion of 3 ml of 50% diluted iodinated contrast, an infusion of 4 ml of 1% Ropivacaine and 80mg of methylprednisolone 40mg/ml will be done.
Experimental: CRF group
This group will be submitted to radiofrequency for sensitive hip branches from the Femoral and Obturator nerves followed by an intraarticular infiltration of corticosteroid + anesthetic similar to the control group.
Procedure: Conventional Radiofrequency (CRF group)
Radiofrequency will be performed with a 22-gauge CRF cannula, 10/15 cm long, 10mm curved active tip, at 90º for 90 seconds, introduced in the anteroposterior and lateromedial directions, to reach the teardrop landmark. Denervation of the articular branches of the Obturator Nerve will be performed in 2 cycles, starting lateral to the lateral edge of the obturator foramen, followed by a point approximately 1cm lateral to the first point. Next, the cannula will be repositioned in a more cranial location, parallel to the superolateral edge of the acetabular dome, to reach the sensory branches of the Femoral Nerve, performing 3 cycles at the 01, 12, and 11 o'clock positions. All lesions will be preceded by motor stimulation at 2,5V and cycles will be followed by the infusion of 2ml of 1% ropivacaine. After concluding the procedure, hip intraarticular infiltration will be performed as described for the control group.
Other Names:
  • Radioablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (WOMAC)
Time Frame: Baseline to 24 weeks ± 1 week.
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
Baseline to 24 weeks ± 1 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Medication Intake
Time Frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
To evaluate pain medication we will use a scale ranging from 0 to 4 (0= no medication; 0 = no medication; 1= use of dipyrone or paracetamol; 2= use of NSAIDs; 3= use of opiate derivatives; 4= routinely scheduled opiate derivatives), considering the last 48 hours.
Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Isometric Peak Force
Time Frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Peak Force of hip flexors, abductors, adductors and extensors.
Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Average Force
Time Frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Average Force of hip flexors, abductors, adductors and extensors. We will also determine intra and inter-rater reliability for isometric force of hip flexors, abductors, adductors and extensors.
Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Incidence of Adverse Effects
Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
To examine the incidence of adverse effects, a questionnaire will be apply to investigate the occurrence of: Hematoma, paresthesia, weakness, worsening of pain, worsening of function or any other adverse effect that participants attribute to the procedure performed.
1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Pain Visual Analogue Scale
Time Frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
The pain visual analogue scale (VAS) is a unidimensional measure of pain intensity, in a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme, "no pain" (score 0) and " worst pain ever" (score 100).
Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
Change in Global Satisfaction
Time Frame: Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week
To evaluate participant satisfaction, we will use 5 points Likert Scale, ranging from 0 to 4 (0= none _ no good at all, ineffective intervention; 1= poor _ some effect but unsatisfactory; 2= fair _ reasonable effect but could be better; 3= good _ satisfactory effect with occasional episodes of pain or stiffness; 4= excellent _ ideal response, virtually pain-free).
Time Frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week

Collaborators and Investigators

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

Sponsor

University of Brasilia

Collaborators

Sarah Network of Rehabilitation Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 14, 2024

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • f3356f

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identified data will be provided for peer revision in an Open database to allow verification of conclusions as well as inclusion in metanalysis studies.

IPD Sharing Time Frame

Data will be available at the moment of publication of the final paper.

IPD Sharing Access Criteria

Open access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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.

Clinical Trials on Hip Pain Chronic

Clinical Trials on Intraarticular Infiltration ( Control group)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe