The following non-randomized prospective studies have less than two years of follow-up data on the IDET* procedure:

• Singh 2000
• Lutz 2003
• Gerszten 2002
• Derby 2000
• Mekhail 2004

Singh V. Intradiscal electrothermal therapy: a preliminary report. Pain Physician. 2000;3:367-373.

Of the 23 patients in this prospective pilot study, 21 were available for follow-up. All patients reported significant relief of pain. Statistically significant differences on all pain scales and significant improvements in walking and standing were seen. No complications were reported. The number and percentage of patients reporting different levels of pain relief after the IDET* procedure were as follows:

• Relief < 50%: 7 (33%)
• Relief > 50%: 14 (67%)

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Lutz C, Lutz GE, Cooke PM. Treatment of chronic lumbar diskogenic (discogenic) pain with intradiskal (intradiscal) electrothermal therapy: a prospective outcome study. Arch Phys Med Rehabil. 2003;84:23-35.

In a prospective study of 33 patients with chronic lumbar discogenic pain treated with the IDET procedure, 77% of the patients said they would have the same procedure performed for the same outcome. The outcome measures used in this study were VAS pain scores, Roland Morris Disability Questionnaire (RMDQ), and North American Spine Society Patient Satisfaction Index (NASS). Mean duration of follow-up was 15 months.

• Mean improvement in VAS scores was 3.9 (P<0.001).
• Mean improvement in RMDQ was 7.3 (P<0.001). The threshold for clinically significant improvement in RMDQ in chronic low back pain is 4-5 points.
• The most common complication after the procedure was increased pain, which is an expected outcome that generally resolves within a week. There were no complications of infection, nerve injury, or dural puncture or tear.

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Gerszten PC, Welch WC, McGrath PM, Willis SL. A prospective outcomes study of patients undergoing intradiscal electrothermy (IDET) for chronic low back pain. Pain Physician. 2002;5:360-364.

Assessments were conducted at baseline and 6 weeks, 3 months, and 1 year after the IDET procedure in 27 patients. At 1 year, 45% reported significant improvement (≥ 7 points) on the SF-36, and 75% had improvement of symptoms on the Oswestry low back pain disability questionnaire. No serious complications were reported. Cerebral spinal fluid was visualized in one case.

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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;3:82-89.

In this prospective outcome study in 32 patients, 4 instruments (RMDQ, VAS, PSI and ADL) were combined to create a classification scheme for rating success. A favorable outcome required improvement on 3 of the instruments. Overall results at 1 year were as follows:

• 62.5% had a favorable outcome.
• 12.5 % had an unfavorable outcome.
• 25% had no change.
• 78% of patients said they would undergo same treatment for same outcome.
• One patient had spinal fusion surgery for persistent discogenic back pain.

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Mekhail N, Kapural L. Intradiscal thermal annuloplasty for discogenic pain: an outcome study. Pain Practice. 2004;4:84-90.

Of 34 patients enrolled, 32 were followed over the next 12 months. Pain disability questionnaires were completed at 2 weeks and 2, 3, 6, 9, and 12 months. VAS scores and ADL self-assessment were also used.

• Significant decrease in pain at 2 weeks post-procedure, sustained 3-12 months (P<0.001).
• Significant improvement in ADL after weeks maintained significance through 12 months.
• Average of 78% pain decrease at 12 months.

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