Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis

NCT05490355 | Terminated

• 1 other identifier: STU-2022-0337
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine if radiofrequency ablation plus steroid perineural injections at the knee or hip provide longer pain relief and better function to patients than the current standard of care, perineural steroid injections alone. This pilot study is a prospective two arm randomized trail, all participants will be recruited from the University of Texas Southwestern Medical Center (UTSW) outpatient orthopedic clinic. 40 participants (20 hip and 20 knee OA) will be enrolled into the standard of care arm (treated with steroid injections alone) and 40 participants (20 hip and 20 knee OA) will be enrolled into the investigational arm (treatment with a combination of radiofrequency ablation (RFA) plus steroid injections) for a total of 80 enrolled participants. All subjects will complete a function and pain assessment at the time of injection and three additional time points: 2 weeks, 3 months, and 6 months post injection. This study will use the same knee function questionnaire and frequency currently used in clinic per standard of care. In addition, all participant's surgical history and prior injection history will be reviewed via the Electronic Medical Record (EMR).

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Osteoarthritis; perineural steroid injections; radiofrequency ablation

Outcome Measures

Primary Outcomes (8)

• Hip Functional score at baseline (pre-procedure)

  Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at baseline (pre-procedure). Possible scores range from 1-100, where lower scores indicate worse function.

  Baseline (Pre-Procedure)

• Hip Functional score at 2 weeks post procedure

  Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 2 weeks post procedure. Possible scores range from 1-100, where lower scores indicate worse function.

  2 weeks post procedure

• Hip Functional score at 3 months post procedure

  Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 3 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.

  3 months post procedure

• Hip Functional score at 6 months post procedure

  Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 6 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.

  6 months post procedure

• Knee Functional score as measured by standard of care questionnaire for knee OA at baseline (pre-procedure)

  Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at baseline (pre-procedure). Possible scores range from 1-100, where higher scores indicate worse function.

  Baseline (pre-procedure)

• Knee Functional score as measured by standard of care questionnaire for knee OA at 2 weeks post procedure

  Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 2 weeks post procedure. Possible scores range from 1-100, where higher scores indicate worse function.

  2 weeks post procedure

• Knee Functional score as measured by standard of care questionnaire for knee OA at 3 months post procedure

  Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 3 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.

  3 months post procedure

• Knee Functional score as measured by standard of care questionnaire for knee OA at 6 months post procedure

  Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 6 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.

  6 months post procedure

Study Arms (2)

Perineural Steroid Injections Alone

ACTIVE COMPARATOR

Participants assigned to this study arm will receive only Perineural Steroid Injections per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.

Procedure: Perineural Steroid Injection

Perineural Steroid Injections Plus Radiofrequency Ablation

EXPERIMENTAL

Participants assigned to this study arm will receive Perineural Steroid Injections plus Radiofrequency Ablation per clinical standards. Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.

Procedure: Radiofrequency Ablation (RFA); Procedure: Perineural Steroid Injection

Interventions

Radiofrequency Ablation (RFA) PROCEDURE

RFA involves heating of periarticular nerves using continuous RFA (80-90C for 60-90 seconds) that results in electromodulation and denervation reducing pain. It can be done under fluoroscopy or CT guidance. CT guidance has additional benefit of better localization of the nerves, as opposed to simple bony landmarks used in fluoroscopy, since nerve branching variations are common and will be used in this study.

Perineural Steroid Injections Plus Radiofrequency Ablation

Perineural Steroid Injection PROCEDURE

Perineural Steroid Injections involve CT guided injection of Local Anesthetic and Steroid into a nerve root of the spine to provide ongoing pain relief.

Perineural Steroid Injections Alone; Perineural Steroid Injections Plus Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age 18 to 100 years
• Osteoarthritis of the knee Kellgren-Lawrence grade 3-4 OR
• Osteoarthritis of the hip Tonnis grades 2 or higher

You may not qualify if:

• History of knee or hip replacement
• History of intra-articular steroid injections within the past 6 weeks
• Active infection

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (7)

• Chen AF, Mullen K, Casambre F, Visvabharathy V, Brown GA. Thermal Nerve Radiofrequency Ablation for the Nonsurgical Treatment of Knee Osteoarthritis: A Systematic Literature Review. J Am Acad Orthop Surg. 2021 May 1;29(9):387-396. doi: 10.5435/JAAOS-D-20-00522.

  PMID: 32701684 BACKGROUND

• Conger A, McCormick ZL, Henrie AM. Pes Anserine Tendon Injury Resulting from Cooled Radiofrequency Ablation of the Inferior Medial Genicular Nerve. PM R. 2019 Nov;11(11):1244-1247. doi: 10.1002/pmrj.12155. Epub 2019 May 24. No abstract available.

  PMID: 30859692 BACKGROUND

• Kim SY, Le PU, Kosharskyy B, Kaye AD, Shaparin N, Downie SA. Is Genicular Nerve Radiofrequency Ablation Safe? A Literature Review and Anatomical Study. Pain Physician. 2016 Jul;19(5):E697-705.

  PMID: 27389113 BACKGROUND

• Li G, Zhang Y, Tian L, Pan J. Radiofrequency ablation reduces pain for knee osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2021 Jul;91:105951. doi: 10.1016/j.ijsu.2021.105951. Epub 2021 Apr 18.

  PMID: 33882358 BACKGROUND

• 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 BACKGROUND

• Chye CL, Liang CL, Lu K, Chen YW, Liliang PC. Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain. Clin Interv Aging. 2015 Mar 16;10:569-74. doi: 10.2147/CIA.S79961. eCollection 2015.

  PMID: 25834413 BACKGROUND

• Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Hip Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2018 Jan;43(1):72-83. doi: 10.1097/AAP.0000000000000694.

  PMID: 29140960 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Avneesh Chhabra, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

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: Chief, Musculoskeletal Radiology

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: December 20, 2022
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)