Article Text

Bipolar radiofrequency ablation of the superomedial (SM), superolateral (SL) and inferomedial (IM) genicular nerves for chronic osteoarthritis knee pain: a randomized double-blind placebo-controlled trial with 12-month follow-up
  1. Wanwipha Malaithong1,
  2. Nuj Tontisirin2,
  3. Rattaphol Seangrung2,
  4. Siwadol Wongsak3 and
  5. Steven P Cohen2,4,5
  1. 1 Department of Anesthesiology, Phramongkutklao Hospital, Bangkok, Thailand
  2. 2 Department of Anesthesiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  3. 3 Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  4. 4 Departments of Anesthesiology and Critical Care Medicine, Neurology, Physical Medicine & Rehabilitation, and Psychiatry & Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
  5. 5 Departments of Anesthesiology and Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA
  1. Correspondence to Dr Nuj Tontisirin, Anesthesiology, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok 73170, Thailand; doctornuj{at}gmail.com

Abstract

Background Variability in anatomy in the knees supports the use of aggressive lesioning techniques such as bipolar-radiofrequency ablation (RFA) to treat knee osteoarthritis (KOA). There are no randomized controlled trials evaluating the efficacy of bipolar-RFA.

Methods Sixty-four patients with KOA who experienced >50% pain relief from prognostic superomedial, superolateral and inferomedial genicular nerve blocks were randomly assigned to receive either genicular nerve local anesthetic and steroid injections with sham-RFA or local anesthetic and steroid plus bipolar-RFA. Participants and outcome adjudicators were blinded to allocation. The primary outcome was Visual Analog Scale pain score 12 months postprocedure. Secondary outcome measures included Western Ontario and McMaster Universities Arthritis (WOMAC) and Patient Global Improvement-Indexes (PGI-I).

Results Both groups experienced significant reductions in pain, with no significant differences observed at 12 months (reduction from 5.7±1.9 to 3.2±2.6 in the RFA-group vs from 5.0±1.4 to 2.6±2.4 in the control-group (p=0.40)) or any other time point. No significant changes were observed between groups for WOMAC and PGI-I at the primary endpoint, with only the control group experiencing a significant improvement in function at 12-month follow-up (mean reduction from 91.2±38.2 to 67.1±51.9 in the RFA-group (p=0.06) vs from 95.8±41.1 to 60.6±42.8 in the control group (p=0.001); p=0.85 between groups).

Conclusion Our failure to find efficacy for genicular nerve RFA, coupled with evidence showing that a plenitude of nerves supply the knee joint and preliminary studies indicating superiority of lesioning strategies targeting more than three nerves, suggest controlled trials using more aggressive lesioning strategies are warranted.

Trial registration number TCTR20170130003.

  • chronic pain
  • pain measurement
  • treatment outcome

Data availability statement

Data are available on reasonable request. Contact coresponding author to request the data sharing.

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Data availability statement

Data are available on reasonable request. Contact coresponding author to request the data sharing.

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Footnotes

  • Contributors WM, NT and RS contributed to the conception and design of the study. WM, NT, RS and SW were involved in data acquisition. WM, NT and SPC analyzed and interpreted data, drafting the article and revising it critically for important intellectual content. All authors approved the final version of the manuscript and agreed to be accountable for all aspects of the work in ensuring that questions related to the integrity of any part of the work were appropriately investigated and resolved. NT accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

  • Funding Internal funding was used to conduct this study. SPC receives funding from the US Dept. of Defense (MIRROR, HU0001-15-2-0003; Congressionally Directed Medical Research Program, 105637007) and National Institutes of Health (GR101558, R01DA048206-01, U24NS115708, 1UH3135804).

  • Competing interests SPC is a consultant for Avanos (which makes radiofrequency equipment) and receives institutional research funding. WM, NT, RS and SW have no conflicts of interest to declare. Currently, SPC is the editorial board member of RAPM.FundingInternal funding was used to conduct this study. SPC receives funding from the U.S. Dept. of Defense (MIRROR, HU0001-15-2-0003; Congressionally Directed Medical Research Program, 105637007) and National Institutes of Health (GR101558, R01DA048206-01, U24NS115708, 1UH3135804).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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