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)