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Pulsed radiofrequency in peripheral posttraumatic neuropathic pain: A double blind sham controlled randomized clinical trial

  • Ethem Akural , Voitto Järvimäki , Raija Korhonen , Hannu Kautiainen and Maija Haanpää EMAIL logo

Abstract

Background and purpose

Pulsed radiofrequency (PRF) is widely used for the treatment of chronic pain, although its mechanism of action is not known. The evidence of efficacy of PRF for neuropathic pain (NP) conditions is limited. A double-blind, randomized, sham-controlled parallel study was conducted to evaluate the efficacy and safety of PRF in the treatment of peripheral posttraumatic NP.

Methods

Forty-five patients with peripheral posttraumatic NP in their upper or lower limb were randomly assigned to receive PRF or sham treatment to the injured peripheral nerve (s) causing peripheral posttraumatic NP. Only patients whose pain intensity was at least 5 on numerical rating scale (NRS) 0–10 and who had suffered from their NP for at least 6 months were included. All patients had dynamic mechanical allodynia or pinprick hyperalgesia in their painful area. They had achieved temporary pain relief of at least 50% with a local nerve block performed at a previous visit. The primary efficacy variable was the difference in 3-day mean pain intensity score from the baseline to 3 months. Other variables included response defined as ≥30% reduction in mean pain intensity at 3 months compared to baseline, Neuropathic Pain Scale (NPS) results, health related quality of life (SF-36) and adverse effects. The skin was anesthetized with 1% lidocaine. A radiofrequency needle was introduced through the skin, and then guided to a SMK cannula (52, 100 or 144mm depending on the target nerve) with 4 or 5mm active tip (SMK-C5-4, SMK-C10-5, SMK-C15-5, Radionics®, Burlington, MA, USA). The nerve was located accurately by stimulating at 50 Hz (threshold <0.5 V). Sham treatment or PRF was applied for 120s 1–4 times at each treatment point (Radionics®, Burlington, MA, USA). The total treatment time was up to 8 min. Both patients and clinicians were blinded during the whole treatment and follow-up period.

Results

Forty-three patients were included in the analyses. There was no statistically significant difference between PRF and sham treatment for the primary outcome efficacy variable.

Seven patients (3 in PRF group and 4 in sham treatment group) achieved ≥30% pain relief (difference between groups was not significant). There was no statistically significant difference in the NPS or any dimension of SF-36 between the treatments. Eighteen patients reported adverse effects. They were mild and did not necessitate any treatment. Transient pain was reported by 17 patients, local irritation by 5 patients and local inflammation by 1 patient. There was no significant difference between the groups in the presence of adverse effects.

Conclusions

PRF was well tolerated, but this study failed to show efficacy of PRF over sham treatment for peripheral posttraumatic NP.

Implications

Based on our results, we do not recommend PRF for peripheral posttraumatic NP. More research of the possible use of PRF for various pain conditions is needed to determine its role in the management of prolonged pains.


DOI of refers to article: http://dx.doi.org/10.1016/j.sjpain.2012.05.071.



Department of Neurosurgery, Helsinki University Central Hospital, P.O. Box 266, 00029 HUS, Helsinki, Finland. Tel.: +358 50 5837722; fax: +358 9 47187560. .

1These authors contributed equally to the study.


Acknowledgements

The study received financial support from the Health Care Foundation of North Finland and research funds of Rehabilitation ORTON.

References

[1] Jensen TS, Baron R, Haanpää M, Kalso E, Loeser JD, Rice AS, Treede RD. A new definition of neuropathic pain. Pain 2011;152:2204–5.10.1016/j.pain.2011.06.017Search in Google Scholar

[2] Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet 2006;367:1618–25.10.1016/S0140-6736(06)68700-XSearch in Google Scholar

[3] Meyer-Rosberg K, Kvarnström A, Kinnman E, Gordh T, Nordfors L, Kristofferson A. Peripheral neuropathic pain – multidimensional burden for patients. Eur J Pain 2001;5:379–89.10.1053/eujp.2001.0259Search in Google Scholar

[4] Finnerup NB, Sindrup SH, Jensen TS. The evidence for pharmacological treatment of neuropathic pain. Pain 2010;150:573–81.10.1016/j.pain.2010.06.019Search in Google Scholar

[5] Attal N, Cruccu G, Baron R, Haanpää M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2009 revision. Eur J Neurol 2010;17:1113–23.10.1111/j.1468-1331.2010.02999.xSearch in Google Scholar

[6] Kalso E, Tasmuth T, Neuvonen PJ. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain 1996;64: 293–302.10.1016/0304-3959(95)00138-7Search in Google Scholar

[7] Tasmuth T, Hartel B, Kalso E. Venlafaxine in neuropathic pain following treatment of breast cancer. Eur J Pain 2002;6:17–24.10.1053/eujp.2001.0266Search in Google Scholar PubMed

[8] Gordh T, Stubhaug A, Jensen T, Arner S, Biber B, Boivie J, Mannheimer C, Kalliomäki J, Kalso E. Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. Pain 2008;138:355–66.10.1016/j.pain.2007.12.011Search in Google Scholar PubMed

[9] Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin a induces direct analgesic effects in neuropathic pain: a double blind placebo controlled study. Ann Neurol 2008;64:274–83.10.1002/ana.21427Search in Google Scholar PubMed

[10] Cheville AL, Sloan JA, Northfelt DW, Jillella AP, Wong GY, Bearden Iii JD, Liu H, Schaefer PL, Marchello BT, Christensen BJ, Loprinzi CL. Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer 2009;17:451–60.10.1007/s00520-008-0542-xSearch in Google Scholar PubMed PubMed Central

[11] Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications – a review. Acta Neurochir (Wien) 2011;153:763–71.10.1007/s00701-010-0881-5Search in Google Scholar

[12] Kim YH, Lee CJ, Lee SC, Huh J, Nahm FS, Kim HZ, Lee MK. Effect of pulsed radiofrequency for postherpetic neuralgia. Acta Anaesthesiol Scand 2008;52: 1140–3.10.1111/j.1399-6576.2008.01752.xSearch in Google Scholar

[13] Munglani R. The long term effect of pulsed radiofrequency for neuropathic pain. Pain 1999;80:437–9.10.1016/S0304-3959(98)00183-3Search in Google Scholar

[14] Rozen D, Ahn J. Pulsed radiofrequency for the treatment of ilioinguinal neuralgia after inguinal herniorraphy. Mt Sinai J Med 2006;73:716–8.Search in Google Scholar

[15] Shah RV, Racz GB. Pulsed mode radiofrequency lesioning to treat chronic post-tonsillectomy pain (secondary glossopharyngeal neuralgia). Pain Pract 2003;3:232–7.10.1046/j.1533-2500.2003.03028.xSearch in Google Scholar

[16] Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to neuropathic pain: the neuropathic pain scale. Neurology 1997;48:332–8.10.1212/WNL.48.2.332Search in Google Scholar

[17] Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey. Med Care 1992;30:473–83.10.1037/t06708-000Search in Google Scholar

[18] Farrar JT, oung Jr JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–58.10.1016/S0304-3959(01)00349-9Search in Google Scholar

[19] Rohof OJJM. Radiofrequency treatment of peripheral nerves. Pain Pract 2002;3:257–60.10.1046/j.1533-2500.2002.02033.xSearch in Google Scholar

[20] Kalso E, Smith L, McQuay HJ, Andrew Moore R. No pain, no gain: clinical excellence and scientific rigour – lessons learned from IA morphine. Pain 2002;98:269–75.10.1016/S0304-3959(02)00019-2Search in Google Scholar

Received: 2011-10-12
Revised: 2012-04-30
Accepted: 2012-04-30
Published Online: 2012-07-01
Published in Print: 2012-07-01

© 2012 Scandinavian Association for the Study of Pain

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