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IDET™

INTRADISCAL ELECTROTHERMAL™ Therapy

More Than Two Years of Follow-up

Prospective Studies More Than Two Years of Follow up
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  • Prospective Studies with Two or More Years of Follow-up
  • Saal 2002
  • Saal 2000
  • Freedman 2003
  • Wetzel 2001
  • Bogduk 2002
  • Karasek 2000
  • Lee 2003

The following non-randomized prospective studies have two or more of years follow-up data on the IDET◊ procedure:

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  • Saal 2002

Saal JA, Saal JS. INTRADISCAL ELECTROTHERMAL◊ treatment for chronic discogenic low back pain: prospective outcome study with minimum 2-year follow-up. Spine. 2002;27:966-974.

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  • Saal 2000

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.

The two published reports above use the same data set. In this prospective study, assessments were conducted at baseline and 6, 12, and 24 months post-procedure in 58 patients:

  • Mean change in VAS at 12 months was 3.0 (P<0.001). A change of 1.8 to 1.9 in patients with chronic low back pain is regarded as clinically significant.
  • Mean change in SF-36 physical function at 12 months was 20.0 (P<0.001). Threshold values for clinically significant change in SF-36 in patients with chronic low back pain vary across studies and by subscale (range: 0.5–24.5).
  • Mean change in SF-36 bodily pain at 12 months was 17 (P<0.001).
  • Symptoms improved in 71% of patients (VAS and SF-36) at 12 months.
  • Twelve patients (19%) did not show any improvement at 12 months.
  • Clinically significant improvement in pain, physical function, and quality of life measured by improvement in VAS and SF-36 scores were noted at 2-year follow-up.
  • No patient treated with the IDET◊ procedure had a complication or adverse event.

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  • Freedman 2003

Freedman BA, Cohen SP, Kuklo TR, Lehman RA, Larkin P, Giuliani JR. INTRADISCAL ELECTROTHERMAL◊ Therapy (IDET◊) for chronic low back pain in active-duty soldiers: 2-year follow-up.Spine J. 2003;3: 502-509.

Thirty-six active-duty soldiers who underwent a single IDET◊ procedure were assessed at 6 months. Thirty-one (86%) were available for a final follow-up 24-46 months after treatment. Data were collected by questionnaire and clinical chart review. Success was defined as ≥ 50% decrease in pain from baseline. Success rates were as follows:

  • 47% (17/36) at 6 months
  • 16% (5/31) at last follow-up

At final follow-up, 16 of 31 (52%) had a persistent decrease in VAS pain score of > 2 points, but early results diminished with time. Nineteen of 31 soldiers were still on active duty at a minimum of 24 months after the procedure. Five transient complications were reported, all within the first month post-procedure.

 

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  • Wetzel 2001

Wetzel FT, Andersson GBJ, Peloza JH, Rashbaum RF, Lee CK, Yuan HA, Phillips FM, An HS. INTRADISCAL ELECTROTHERMAL◊ Therapy (IDET◊) to treat discogenic low back pain: two year results of a multi-center prospective cohort study. Presented at the 16 th Annual Meeting of the North American Spine Society. November 2001. Abstract.

Seventy-eight patients were followed up at 1 and 2 years post-procedure. At 2 years, 75% compliance was reported. Two patients were withdrawn from the study. Results at 2 years were as follows:

  • 88% would definitely or probably choose the same treatment.
  • 61% were performing 100% of their job vs 23% of patients before treatment.
  • Only 18% required subsequent back surgery.

Proven Reduction in Pain

IDET_Procedure_ClinicalStudies_NonrandomizedStudies_ReductioninPain


Proven Increase in Functioning

IDET_Procedure_ClinicalStudies_NonrandomizedStudies_IncreaseinFunctioning

In this multicenter study of 78 patients, the IDET◊ procedure was shown to significantly reduce pain and significantly improve physical function in patients observed 24 months after the treatment1.

1 Wetzel FT, Andersson GBJ, Peloza JH, Rashbaum RF, Lee CK, Yuan HA, Phillips FM, An HS. Intradiscal electrothermal therapy (IDET◊) to treat discogenic low back pain: two year results of a multi-center prospective cohort study. Presented at the 16 th Annual Meeting of the North American Spine Society. November 2001. Abstract.

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  • Bogduk 2002

Bogduk N, Karasek M. Two-year follow-up of a controlled trial of INTRADISCAL ELECTROTHERMAL◊ anuloplasty for chronic low back pain resulting from internal disc disruption. Spine J. 2002;2:343-350.

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  • Karasek 2000

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(20):2601-2607.

The two published reports above use the same data set. Of 53 patients recruited for this study, 17 were refused insurance coverage and acted as a control group for the 36 patients who underwent the IDET◊ procedure. Patients were followed up 3 months and 1 and 2 years post-procedure.

  • The control group showed no significant improvement.
  • The IDET◊ procedure group showed significant improvement in median pain scores at 1 and 2 years. At 2 years post-procedure:
    • 54% of patients had 50% relief of pain, no opioid use, and were back at work
    • 20% were pain free and back at work

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  • Lee 2003

Lee MS, Cooper G, Lutz, GE, Lutz C, Hong HM. INTRADISCAL ELECTROTHERMAL◊ Therapy (IDET◊) for treatment of chronic lumbar discogenic pain: a minimum 2-year clinical outcome study. Pain Physician. 2003;6:443-448.

  • Of the 62 patients who had the IDET◊ procedure, 51 (82%) were available for follow-up a minimum of 24 months later. Statistically significant improvements were reported in low back visual numeric pain scale (VNS), Roland Morris disability evaluation (RM), and lower extremity (LE) pain scores (P<0.001).
  • 53% of patients (27/ 51) had clinically significant improvements in VNS and RM.
  • 63% (32/51) said they would undergo same procedure again for same result.
  • Seven patients (14%) underwent additional therapeutic procedures during follow-up; only 2 had spinal fusion.
  • No complications of dural puncture, infection, or nerve injury were reported.

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