PAIN
Volume 145, Issue 3 , Pages 279-286 , October 2009

A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy – A 12-month follow-up

  • Gunnvald Kvarstein

      Affiliations

    • Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway
    • Corresponding Author InformationCorresponding author. Address: Department of Anesthesia and Intensive Care, Rikshospitalet University Hospital, Sognsvannsv 20, 0027 Oslo, Norway. Tel.: +47 23070000; fax: +47 23073690.
    • ,
  • Leif Måwe

      Affiliations

    • Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway
    • ,
  • Aage Indahl

      Affiliations

    • Hospital for Rehabilitation, Oslo University Hospital, Rikshospitalet, Norway
    • ,
  • Per Kristian Hol

      Affiliations

    • The Interventional Centre, Oslo University Hospital, Rikshospitalet, Norway
    • ,
  • Bjørn Tennøe

      Affiliations

    • Department of Radiology, Oslo University Hospital, Rikshospitalet, Norway
    • ,
  • Randi Digernes

      Affiliations

    • Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway
    • ,
  • Audun Stubhaug

      Affiliations

    • Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway
    • ,
  • Tor Inge Tønnessen

      Affiliations

    • Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway
    • Oslo University Hospital, Rikshospitalet and Faculty of Medicine, University of Oslo, Norway
    • ,
  • Harald Beivik

      Affiliations

    • Department of Anesthesiology and Intensive Care, Section of Pain Management, Oslo University Hospital, Rikshospitalet, Norway
    • Oslo University Hospital, Rikshospitalet and Faculty of Medicine, University of Oslo, Norway

Received 8 August 2008 ,Revised 23 April 2009 ,Accepted 1 May 2009.

References 

  1. Altman D. Practical statistics for medical research. London: Chapman & Hall/CRC; 1991;
  2. Barendse GA, van Den Berg SG, Kessels AH, Weber WE, van Kleef M. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-s 70°C lesion. Spine. 2001;26:287–292
  3. Bender R, Lange S. Adjusting for multiple testing – when and how?. J Clin Epidemiol. 2001;54:343–349
  4. Breivik EK, Bjørnsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000;16:22–28
  5. Caraceni A, Cherny N, Fainsinger R, Kaasa S, Poulain P, Radbruch L, et al. Pain measurement tools and methods in clinical research in palliative care: Recommendations of an Expert Working Group of the European Association of Palliative Care. J Pain Symptom Manage. 2002;23:239–255
  6. Cleeland CS. Pain assessment in cancer. In: Osoba D, editor. Effect of cancer on quality of life. Boca Raton; 1991.
  7. Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983;17:197–210
  8. Derby R, Eek B, Chen Y, O’neill C, Ryan D. Intradiscal Electrothermal Annuloplasty (IDET): A Novel Approach for Treating Chronic Discogenic Back Pain. Neuromodulation. 2000;3:69–75
  9. Endres S, Bogduk N. Practice guidelines and protocols. Lumbar disc stimulation. In: Syllabus of the ISIS ninth annual scientific meeting, San Fransisco: International Spinal Injection Society; 2001, p. 1456–75.
  10. Ercelen O, Bulutcu E, Oktenoglu T, Sasani M, Bozkus H, Cetin SA, et al. Radiofrequency lesioning using two different time modalities for the treatment of lumbar discogenic pain: a randomized trial. Spine. 2003;28:1922–1927
  11. Erdine S, Yucel A, Celik M. Percutaneous annuloplasty in the treatment of discogenic pain: retrospective evaluation of one year follow-up. Agri. 2004;16:41–47
  12. Fairbank JCT, Couper J, Davies JB. The Oswestry Low Back Pain Questionnaire. Physiotherapy. 1980;66:271–273
  13. Finch PM. The use of radiofrequency heat lesions in the treatment of lumbar discogenic pain. Pain Pract. 2002;2:235–240
  14. Finch PM, Price LM, Drummond PD. Radiofrequency heating of painful annular disruptions: one-year outcomes. J Spinal Disord Tech. 2005;18:6–13
  15. Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2005;30:2369–2377
  16. Freeman BJ, Mehdian R. Intradiscal electrothermal therapy, percutaneous discectomy, and nucleoplasty: what is the current evidence?. Curr Pain Headache Rep. 2008;12:14–21
  17. Goldberg SN, Gazelle GS, Dawson SL, Rittman WJ, Mueller PR, Rosenthal DI. Tissue ablation with radiofrequency: effect of probe size, gauge, duration, and temperature on lesion volume. Acad Radiol. 1995;2:399–404
  18. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials. 1996;17:1–12
  19. Kapural L, Hayek S, Malak O, Arrigain S, Mekhail N. Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the treatment of discogenic pain: a prospective matched control trial. Pain Med. 2005;6:425–431
  20. Karasek M, Bogduk N. Twelve-month follow-up of a controlled trial of intradiscal thermal anuloplasty for back pain due to internal disc disruption. Spine. 2000;25:2601–2607
  21. Klepstad P, Loge JH, Borchgrevink PC, Mendoza TR, Cleeland CS, Kaasa S. The Norwegian brief pain inventory questionnaire: translation and validation in cancer pain patients. J Pain Symptom Manage. 2002;24:517–525
  22. Linton SJ, Götestam KG. A clinical comparison of two pain scales: correlation, remembering chronic pain, and a measure of compliance. Pain. 1983;17:57–65
  23. Linton SJ, Melin L. The accuracy of remembering chronic pain. Pain. 1982;13:281–285
  24. Loge JH, Kaasa S. Short form 36 (SF-36) health survey: normative data from the general Norwegian population. Scand J Social Med. 1998;26:250–258
  25. Mogil JS, Chanda ML. The case for the inclusion of female subjects in basic science studies of pain. Pain. 2005;117:1–5
  26. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–1194
  27. Pauza KJ, Howell S, Dreyfuss P, Peloza JH, Dawson K, Bogduk N. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004;4:27–35
  28. Pengel LH, Refshauge KM, Maher CG. Responsiveness of pain, disability, and physical impairment outcomes in patients with low back pain. Spine. 2004;29:879–883
  29. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcome study with minimum 1-year follow-up. Spine. 2000;25:2622–2627
  30. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain: prospective outcome study with a minimum 2-year follow-up. Spine. 2002;27:966–973
  31. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–412
  32. Stewart M, Maher CG, Refshauge KM, Bogduk N, Nicholas M. Responsiveness of pain and disability measures for chronic whiplash. Spine. 2007;32:580–585
  33. Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003;106:337–345
  34. Unruh AM. Gender variations in clinical pain experience. Pain. 1996;65:123–167
  35. Urrutia G, Kovacs F, Nishishinya MB, Olabe J. Percutaneous thermocoagulation intradiscal techniques for discogenic low back pain. Spine. 2007;32:1146–1154
  36. Ware JE, Kosinski M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston, Boston: Institute Health; 2003;
  37. World Medical Association. World Medical Association Declaration of Helsinki. 18th World Medical Association General Assembly Helsinki, Finland – 29th World Medical Association General Assembly, Tokyo, Japan, October, 1975; 35th World Medical Association General Assembly, Venice, Italy, October, 1983; 41st World Medical Association General Assembly, Hong Kong, September 1989; 48th World Medical Association General Assembly, Somerset West, Republic of South Africa, October, 1996; 52nd World Medical Association General Assembly, Edinburgh, Scotland, October 2000; 2000.

PII: S0304-3959(09)00265-6

doi: 10.1016/j.pain.2009.05.001

PAIN
Volume 145, Issue 3 , Pages 279-286 , October 2009

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