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PMID- 28672319
OWN - NLM
STAT- In-Process
DA  - 20170703
LR  - 20170703
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 318
IP  - 1
DP  - 2017 Jul 04
TI  - Effect of Radiofrequency Denervation on Pain Intensity Among Patients With
      Chronic Low Back Pain: The Mint Randomized Clinical Trials.
PG  - 68-81
LID - 10.1001/jama.2017.7918 [doi]
AB  - 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.
FAU - Juch, Johan N S
AU  - Juch JNS
AD  - Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, the
      Netherlands.
FAU - Maas, Esther T
AU  - Maas ET
AD  - Department of Health Sciences, Faculty of Earth and Life Sciences, Vrije
      Universiteit Amsterdam, Amsterdam, the Netherlands3The EMGO+ Institute for Health
      and Care Research, Amsterdam, the Netherlands.
FAU - Ostelo, Raymond W J G
AU  - Ostelo RWJG
AD  - Department of Health Sciences, Faculty of Earth and Life Sciences, Vrije
      Universiteit Amsterdam, Amsterdam, the Netherlands3The EMGO+ Institute for Health
      and Care Research, Amsterdam, the Netherlands4Department of Epidemiology and
      Biostatistics, Vrije Universiteit Medical Centre Amsterdam, Amsterdam, the
      Netherlands.
FAU - Groeneweg, J George
AU  - Groeneweg JG
AD  - Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, the
      Netherlands.
FAU - Kallewaard, Jan-Willem
AU  - Kallewaard JW
AD  - Department of Anesthesiology, Rijnstate hospital, Velp, the Netherlands.
FAU - Koes, Bart W
AU  - Koes BW
AD  - Department of General Practice, Erasmus University Medical Centre, Rotterdam, the
      Netherlands.
FAU - Verhagen, Arianne P
AU  - Verhagen AP
AD  - Department of General Practice, Erasmus University Medical Centre, Rotterdam, the
      Netherlands.
FAU - van Dongen, Johanna M
AU  - van Dongen JM
AD  - Department of Health Sciences, Faculty of Earth and Life Sciences, Vrije
      Universiteit Amsterdam, Amsterdam, the Netherlands3The EMGO+ Institute for Health
      and Care Research, Amsterdam, the Netherlands.
FAU - Huygen, Frank J P M
AU  - Huygen FJPM
AD  - Department of Anesthesiology, Erasmus University Medical Centre, Rotterdam, the
      Netherlands.
FAU - van Tulder, Maurits W
AU  - van Tulder MW
AD  - Department of Health Sciences, Faculty of Earth and Life Sciences, Vrije
      Universiteit Amsterdam, Amsterdam, the Netherlands3The EMGO+ Institute for Health
      and Care Research, Amsterdam, the Netherlands.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2017/07/04 06:00
MHDA- 2017/07/04 06:00
CRDT- 2017/07/04 06:00
AID - 2635632 [pii]
AID - 10.1001/jama.2017.7918 [doi]
PST - ppublish
SO  - JAMA. 2017 Jul 4;318(1):68-81. doi: 10.1001/jama.2017.7918.