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. Author manuscript; available in PMC: 2015 Jul 15.
Published in final edited form as: Spine (Phila Pa 1976). 2014 Jul 15;39(16):1314–1324. doi: 10.1097/BRS.0000000000000401

Table 5.

Ablative Therapies for Discogenic Low Back Pain.

Study Intervention Outcomes assessed Time
points of
Outcomes
Blinding Study Design Significant Findings
Pauza et al., 2004 IDET VAS Pain, SF-36, ODI, relative changes in pain Baseline, 6 months Subjects and Investigator assessing clinical outcomes were blinded.

Investigator performing the Intervention was not blinded.
Active Therapy: IDET catheter (SpineCath Catheters, Andover, MA, USA) is placed at boundary between AF and NP and heated to 90 C.

Sham Therapy: Only the Introducer Needle was introduced.
Changes in VAS score and ODI between 6 months and baseline significantly favored IDET group over sham.
Relative decreases in pain significantly favored IDET over sham.
Freeman et al., 2005 IDET VAS Pain, LBOS, ODI, SF-36, Zung Depression Index, Modified Somatic Perception Questionnaire, Sitting tolerance, work tolerance, medication, and any neurologic complications. Clinical success defined as improvement in LBOS by ≥7 points and SF-36 by 1 standard deviation. Baseline, 6 months Subjects, Investigator performing the Intervention and Investigator assessing clinical outcomes were all blinded. Active Therapy: IDET catheter was introduced to cover 75% of the posterior annulus or annular tears and then heated from 65 C to 90 C.

Sham Therapy: Catheter was introduced the same manner but never heated.
No post-procedure complications.
No significant differences in change of outcome scores from baseline between sham and IDET groups at 6 months.
Kvarstein et al., 2009 PIRFT Change in pain intensity for worst pain, least pain, average pain and pain (NRS)
Categorical impression of pain, Brief Pain Inventory, SF-36, ODI, and patient specific function scale (number of activities of daily living)
Baseline, 1, 3, 6, and 12 months Subjects, operators and investigators assessing clinical outcomes were all blinded. Active Therapy: discTRODE™ probe (Radionics RFG-3C Valleylab, Tyco Healthcare Group LP 5920 Colorado 80301-3299 USA) was inserted into the intervertebral disc. RF heating started at 50 C and increased by 5 C every second minute until 65 C and then as held at constant temperature for 4 minutes.

Sham Therapy: Probe was inserted in the disc but no RF heating
No significant differences in any of the NRS pain intensity scores between sham and active therapy.
No significant differences in categorical impression of pain, ODI, SF-36 scores at 6 or 12 months.
Barendse et al., 2001 PIRFT VAS Pain (10 point scale), Analgesic intake. ODI, Darmouth COOP Functional Health Assessment Charts/World Organization of Primary Care Physicians, Global Perceived Effects, number of analgesics. Clinical Success defined as ≥ 2 in VAS and ≥ 50% pain reduction on Global Perceived Effects. Baseline and 8 weeks Subjects, investigators performing the intervention and investigators assessing outcomes were all blinded. Active Therapy: RF probe (Radionics, Burlington, MA, USA) was placed in the center of the disc. A 90 second 70 C RF was used.

Sham Therapy: RF probe was placed in center of the disc. No heating was applied.
No significant differences between sham and control for any of the outcomes.
Oh et al., 2004 Ramus Ablation Communicas VAS Pain and SF-36 Bodily Pain and Physical Function Baseline and 4 months No Blinding Active Therapy: Ramus Communicans was ablated by RF probe (Stryker Leibinger GmbH & Co. KG, Freiburg, Germany)

Sham Therapy: No ablation of Ramus Communicans
Significant improvements in VAS Pain scores and SF-36 Bodily pain and Physical Function at 4 months.
Kapural et al. 2012 Intradiscal Biacuplasty SF-36, NRS, ODI, Health Care Utilization Baseline, 1, 3 and 6 months Patient, investigator assessing outcomes were blinded.

Investigator performing intervention was not blinded
Active Therapy:
Two transDiscal probes (Kimberly Clark Health Care, Rosewell, GA, USA) placed in the disc at a posterlateral oblique angle delivered RF energy at 45 C or 50 C. 15 patients also underwent monopolar lesioning at 50 C for 2.5 minutes.

Sham Therapy: Mimic Active therapy except electrodes were positioned just outside the disc
No significant differences in outcomes or improvement in outcomes at 1 or 3 months between sham and active therapy.

Significant differences in SF-36, NRS, ODI scores and improvements in these scores favoring active over sham therapy at 6 months.

Abbreviations: VAS (Visual Analogue Scale), ODI (Oswetry Disability Index), SF-36 (Short Form 36), NRS (Numeric Rating Scale), LBOS (Low Back Pain Outcome Score), IDET (Intradiscal Electrothermal Treatment), RF (Radiofrequency)