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Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back PainThe Mint Randomized Clinical Trials

Educational Objective
To learn whether radiofrequency denervation is an effective treatment for patients with chronic low back pain.
1 Credit CME
Key Points

Question  What is the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain?

Findings  In 3 randomized clinical trials including 681 participants with chronic low back pain originating from the facet joints, sacroiliac joints, or a combination of these or the intervertebral disks, radiofrequency denervation combined with exercise compared with exercise alone resulted in either no significant difference in pain intensity, or a difference smaller than the prespecified minimal clinically important difference after 3 months.

Meaning  The study findings do not support the use of radiofrequency denervation for chronic low back pain originating from these sources.

Abstract

Importance  Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking.

Objective  To evaluate the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain.

Design, Setting, and Participants  Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in the Netherlands. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care.

Interventions  All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3.

Main Outcomes and Measures  The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015.

Results  Among 681 participants who were randomized (mean age, 52.2 years; 421 women [61.8%], mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was −0.18 (95% CI, −0.76 to 0.40) in the facet joint trial; −0.71 (95% CI, −1.35 to −0.06) in the sacroiliac joint trial; and −0.99 (95% CI, −1.73 to −0.25) in the combination trial.

Conclusions and Relevance  In 3 randomized clinical trials of participants with chronic low back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a standardized exercise program resulted in either no improvement or no clinically important improvement in chronic low back pain compared with a standardized exercise program alone. The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources.

Trial Registration  trialregister.nl Identifier: NTR3531

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Article Information

Corresponding Author: Esther T. Maas, PhD, School of Population and Public Health, University of British Columbia, 2206 E Mall, Vancouver, BC V6T 1Z3, Canada (esther.maas@ubc.ca).

Accepted for Publication: June 6, 2017.

Correction: This article was corrected for value errors in Figure 3 on September 26, 2017.

Author Contributions: Drs Maas and Juch had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Juch and Maas are shared first author, listed in alphabetical order.

Concept and design: Juch, Maas, Ostelo, Groeneweg, Kallewaard, Koes, Verhagen, Huygen, van Tulder.

Acquisition, analysis, or interpretation of data: Juch, Maas, Koes, van Dongen, Huygen, van Tulder.

Drafting of the manuscript: Juch, Maas, Ostelo, Groeneweg, Koes, Verhagen, Huygen, van Tulder.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Juch, Maas, van Dongen.

Obtained funding: Koes, Huygen, van Tulder.

Administrative, technical, or material support: Juch, Maas, Kallewaard, Huygen.

Supervision: Ostelo, Groeneweg, Huygen, van Tulder.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Ostelo reports receiving grant funding from the Netherlands Organisation for Scientific Research and Scientific Association Physiotherapy. Dr van Tulder reports receiving funding to his institution from professional organizations (eg, the Royal Dutch Association for Physiotherapy; the Netherlands National Chiropractic Association and the European Chiropractic Union); travel expenses by the organizing professional organizations when speaking at conferences; and honoraria for reviewing grant proposals from Swedish and Canadian governmental grant agencies. He has not received any honoraria or travel expenses from the industry. No other disclosures were reported.

Funding/Support: This study was funded by grant 171202013 from the Netherlands Organization for Health Research and Development, by the Dutch Society for Anesthesiology, and the Dutch health insurance companies.

Role of the Funder/Sponsor: The funders played no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.

Additional Contributions: We thank Merel van Raamt, PT, and Robert van Cingel, PhD (both from Sports Medical Centre Papendal [SMCP]), for their help in developing the exercise program. SMCP received financial support from the research grant for the development of the protocol. We also thank all participants, physiotherapists, and everyone working on the Mint study at the participating pain clinics. The participating pain clinics received reimbursement from the research grant for their extra study-related administrative tasks.

Additional Information: The following were in charge of participant recruitment and treatment per clinic: Bernard Lo, MD (Diakonessenhuis Utrecht/Zeist); Harmen Pelleboer, MD (Medisch Centrum Alkmaar); Jasper Kal, MD, PhD, FIPP (Onze Lieve Vrouwe Gasthuis Amsterdam); Dennis Harhangi, MD (Havenziekenhuis Rotterdam); Renate Munnikes, MD, FIPP (Maasstad ziekenhuis Rotterdam); Willem-Jan Hofsté, MD (St Antonius ziekenhuis Nieuwegein); Katja Bürger, MD (Alrijne ziekenhuis Leiderdorp); Michel Wagemans, MD (Reinier de Graaf Gasthuis Delft); Mettje Hanje, MD (Medisch Spectrum Twente Enschede); Michel Terheggen, MD (Rijnstate ziekenhuis Velp); Gilbert Tjiang, MD (Amphia ziekenhuis Breda); Maurice Giezeman, MD (Isala klinieken, Zwolle); Joep Scholten, MD (Gelre ziekenhuis Apeldoorn); Eric van den Bosch, MD (Medisch Centrum Leeuwarden); Antal van der Gaag, MD (Catharina ziekenhuis Eindhoven); Hans Aukes, MD (Albert Schweitzer ziekenhuis Sliedrecht).

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