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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized, Double-Blind, Comparative-Effectiveness Study Comparing Pulsed Radiofrequency to Steroid Injections for Occipital Neuralgia or Migraine with Occipital Nerve Tenderness.
- Steven P Cohen, B Lee Peterlin, Larry Fulton, Edward T Neely, Connie Kurihara, Anita Gupta, Jimmy Mali, Diana C Fu, Michael B Jacobs, Anthony R Plunkett, Aubrey J Verdun, Milan P Stojanovic, Steven Hanling, Octav Constantinescu, Ronald L White, Brian C McLean, Paul F Pasquina, and Zirong Zhao.
- aDepartments of Anesthesiology and Critical Care Medicine, and Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, Baltimore, MD, USA, and Uniformed Services University of the Health Sciences, Bethesda, MD, USA bDepartment of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA cDepartment of Health Organization Management, Texas Tech School of Medicine, Lubbock, TX, USA Departments of dNeurology eSurgery, and fNursing, Walter Reed National Military Medical Center, Bethesda, MD, USA gDepartment of Anesthesiology, Drexel University, Philadelphia, PA, USA hWomack Army Medical Center, Fort Bragg, NC, USA iDepartment of Neurology, Naval Medical Center-San Diego, San Diego, CA, USA Departments of jPhysical Medicine and Rehabilitation and kAnesthesiology, Walter Reed National Military Medical Center, Bethesda, MD, USA lDepartment of Anesthesiology, Boston VA Hospital, Boston, MA, USA mDepartment of Anesthesiology, Naval Medical Center-San Diego, San Diego, CA, USA nDepartment of Surgery, Landstuhl Regional Medical Center, Landstuhl, Germany oDepartment of Surgery, Tripler Army Medical Center, Honolulu, HI, USA pDepartment of Physical Medicine and Rehabilitation, Uniformed Services University of the Health Sciences, Bethesda, MD, USA Departments of qInternal Medicine and rNeurology, DC VA Hospital, Washington, DC, USA.
- Pain. 2015 Dec 1; 156 (12): 2585-94.
AbstractOccipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline -2.743 ± 2.487 vs -1.377 ± 1.970; P < 0.001), than the steroid group, which persisted through the 6-month follow-up. Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline -1.925 ± 3.204 vs -0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline -2.738 ± 2.753 vs -1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures.
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