Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With Hip OA Compared to Intra-articular Steroid Injections

NCT04329884 | Unknown FDA Device

• 1 other identifier: Brigham
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Change in visual analog scale (VAS) pain by 1.5 points

  VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

  up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.

Secondary Outcomes (7)

• visual analog scale (VAS) pain scores at each follow-up time point

  4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure

• Physical performance (hip range of motion)

  4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment

• Physical performance (50 ft walk test)

  4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment

• Hip disability and Osteoarthritis Outcome Score (HOOS)

  4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure

Study Arms (2)

Intra-articular corticosteroid injections

ACTIVE COMPARATOR

The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. Radiology guidance will be used to guide needle placement within the affected hip to administer lidocaine and a corticosteroid intra-articularly.

Drug: intra-articular corticosteroid injection

Cooled radiofrequency ablation

ACTIVE COMPARATOR

The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. The HALYARD\* COOLIEF\* SINERGY\* Cooled Radiofrequency Probe (sterile, single use) is inserted through a COOLIEF\* SINERGY\* Introducer used with fluoroscopy guidance in the AP view to visualize the hip joint and sensory nerve areas over the acetabulum (femoral) and ischium (obturator) where the cooled radiofrequency ablation will be applied to create a focal thermal lesion to encompass and denervate the targeted nerves.

Procedure: Cooled RFA treatment with COOLIEF* device

Interventions

Cooled RFA treatment with COOLIEF* device PROCEDURE

Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.

Also known as: cooled radiofrequency ablation (CRFA)

Cooled radiofrequency ablation

intra-articular corticosteroid injection DRUG

Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.

Also known as: steroid injection

Intra-articular corticosteroid injections

Eligibility Criteria

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

You may qualify if:

• Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4)
• Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves

You may not qualify if:

• Patients who have received any steroid injection in hip within the last 90 days
• Individuals who cannot consent for themselves such as children and subjects with impaired decision making
• Local infection at injection site or active systemic infection
• Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
• Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist
• Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
• Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol
• Negative diagnostic nerve block tests

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Rothman Institute Orthopaedics: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02511, United States

RECRUITING

Related Publications (7)

• Oladeji LO, Cook JL. Cooled Radio Frequency Ablation for the Treatment of Osteoarthritis-Related Knee Pain: Evidence, Indications, and Outcomes. J Knee Surg. 2019 Jan;32(1):65-71. doi: 10.1055/s-0038-1675418. Epub 2018 Nov 5.

  PMID: 30396206 RESULT

• Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

  PMID: 29095245 RESULT

• Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16:rapm-2018-100051. doi: 10.1136/rapm-2018-100051. Online ahead of print.

  PMID: 30772821 RESULT

• Bellini M, Barbieri M. Cooled radiofrequency system relieves chronic knee osteoarthritis pain: the first case-series. Anaesthesiol Intensive Ther. 2015;47(1):30-3. doi: 10.5603/AIT.2015.0003.

  PMID: 25751290 RESULT

• Gupta G, Radhakrishna M, Etheridge P, Besemann M, Finlayson RJ. Radiofrequency denervation of the hip joint for pain management: case report and literature review. US Army Med Dep J. 2014 Apr-Jun:41-51.

  PMID: 24706242 RESULT

• Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. Orthopedics. 2012 Mar 7;35(3):e302-5. doi: 10.3928/01477447-20120222-19.

  PMID: 22385437 RESULT

• Kapural L, Jolly S, Mantoan J, Badhey H, Ptacek T. Cooled Radiofrequency Neurotomy of the Articular Sensory Branches of the Obturator and Femoral Nerves - Combined Approach Using Fluoroscopy and Ultrasound Guidance: Technical Report, and Observational Study on Safety and Efficacy. Pain Physician. 2018 May;21(3):279-284.

  PMID: 29871372 RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Adrenal Cortex Hormones; Steroids

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Antonia F Chen, MD/ MBA

CONTACT

617-535-5935; afchen@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: December 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 1, 2022
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)