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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), also known as intradiscal radiofrequency thermomodulation, RF annuloplasty, or radiofrequency posterior annuloplasty is a minimally invasive method similar to IDET except the catheter, the Radionics RF Disc Catheter Electrode System also called discTRODE RF Catheter Electrode System, is placed into the center of the disc rather than around the annulus. The Radionics catheter system is designed for patients with chronic discogenic back pain for the coagulation and decompression of disk material to treat Discogenic Pain, Treatment - Commercial Medical Management Guideline symptomatic patients with annular disruption of contained herniated disks.

The nucleoplasty technique, also known as percutaneous disc decompression, produces disc decompression in symptomatic patients with contained herniated discs. Nucleoplasty utilizes a proprietary technology called Coblation(TM) for ablating and coagulating soft tissue to accomplish partial disc removal. Coblation ablates tissue via a low-temperature, molecular dissociation process to create small channels within the disc. A special bipolar wand (Perc-D Coblation Channeling Wand) inserted through a percutaneous guided needle allows for treatment of the herniated disc.

Percutaneous endoscopic discectomy is performed under local anesthesia since patient cooperation is required during the procedure. The disc space is punctured with a cannula and the tip of the needle is placed into the center of the disc. A second cannula is placed on the opposite lateral side of the disc. Parts of the nucleus pulposus are removed to allow for examination. The remaining disc material is vaporized using a laser.

Percutaneous sacroplasty is a minimally invasive surgical treatment that attempts to repair sacral insufficiency fractures using polymethylmethacrylate (PMMA) bone cement. For this procedure, 2 thin, hollow tubes are placed in the lower back, over the left half and right half of the sacrum, guided by images from x-rays or computed tomography scans. The surgeon then advances a needle through each tube to the site of the sacral fracture and injects 2 to 5 mL of bone cement, with care taken to avoid allowing cement onto the sacral nerves. (Hayes, Percutaneous Sacroplasty for Treatment of Sacral Insufficiency Fractures, 2009) Clinical Evidence Intradiscal electrothermal therapy (IDET) and intradiscal biacuplasty (IDB) Saal and Saal (2000a) reported the results of 25 consecutive patients with chronic back pain (duration 10 months to 11 years) who were followed at 6 and 12 months post-IDET. The authors reported pre- and post-treatment (minimum, 6 months) means for a 10-point visual analogue pain scale (VAS), sitting tolerance, physical function (SF-36), and bodily pain scale. Statistically significant changes were reported for all four measures. There was a mean reduction in VAS of 3.74, a mean increase of 15 points on the SF-36, and a mean increase of 14 points on the bodily pain scale. Eighteen of 25 patients reported an improvement in sitting tolerance (from 23.6 minutes pretreatment to 47.2 minutes post-treatment).

Weaknesses of the study include the small sample size, that the trial was not blinded or randomized, the short follow-up, and reliance on subjective measures of improvement. In addition, the investigators reported that "co-intervention was kept to a minimum, and consisted of noncreative treatments to which they already had been exposed without success before thermal treatment," but no further description of potentially confounding therapy was provided.

In another study by Saal and Saal, (2000b) results of IDET were reported for 62 consecutive patients with chronic low back pain. Again, outcome measures included visual analogue scale (VAS) pain scores, Short Form (SF-36) Health Status Questionnaire Physical Function subscale and SF-36 Bodily Pain subscale scores at baseline and at least one year later. It appears that there is probable overlap in the subjects reported in the series above and in this series of patients, i.e.

that the results of the above study are not additional to, but are included in these results. Mean preoperative duration of symptoms was reported as 5 years, and mean follow-up as 16 months. Mean changes in VAS score was 3.0, in SF-36 physical function was 20, and in bodily pain was 17. Twelve (19%) of the patients did not show improvement on any scale. The investigators suggested that while a cohort of patients demonstrated statistically significant and clinically meaningful improvement at one year post-operatively, the results should be validated with "placebo-controlled randomized trials and studies comparing IDET with alternative treatments." This study's design and weaknesses were similar to those described in the earlier study.

A prospective study by Derby et al., (2000) reported results for 32 patients with back pain for longer than 6 months, who underwent IDET. One-year results were reported on outcome measures of 1) pain relief, using a 10-point VAS scale, and

2) a 24-point Roland and Morris (RM) Disability Questionnaire. Mean decrease in VAS scores was 1.84 and in RM score was 4.03. Seventy-eight percent of patients reported that they would undergo the procedure again, with 53.1% of patients

Discogenic Pain, Treatment - Commercial Medical Management Guideline

believing their condition was better than before the procedure, 34.4% perceiving no change in condition, and 12.5% believing their condition worse. However, the investigators reported that 62.5% of patients had a favorable outcome, 25% no change, and 12.5%, an unfavorable outcome.

A prospective case series by Lutz et al., (2003) reported results for 33 patients with chronic constant lumbar discogenic pain who have not responded to at least 6 months of aggressive nonoperative care, who underwent IDET (9). Fifteen months results were reported on outcome measures of 1) pain relief, using the Roland and Morris (RM) Disability Questionnaire, 2) visual analog scale (VAS) pain scores for the back and for the lower extremity, and 3) North American Spine Society Patient Satisfaction Index. Relief of pain and improvement in physical function were associated with a mean change in the VAS score of 3.9, a mean change in the lower-extremity VAS score of 3.7, and a mean change in the RMDQ of 7.3. For patient satisfaction, 75.7% reported that they would undergo the same procedure for the same outcome. Complete pain relief was achieved in 24% of the patients, and partial pain relief in 46% of the patients. The authors concluded that IDET offers a safe, minimally invasive treatment option for carefully selected patients with chronic lumbar discogenic pain who have not responded to aggressive nonoperative care.

Karasek and Bogduk (2004) reported results of a case-controlled study of 53 patients with back pain caused by internal disc disruption. 35 of the patients whose insurance would cover the procedure received IDET, and 17 of the patients who did not have insurance that would cover the procedure were deemed "controls," and received physical therapy, education and counseling. Outcomes evaluated were pain using a 10-point VAS scale, return to work, and use of opioid analgesics.

In the control group, at three months, VAS scores were improved in 3, unchanged in 4, and worsened in 9. The remaining measures included reporting of only 15 patients, but the investigators did not explain why 17 three-month VAS scores were reported, but only 15 return-to-work and 16 opioid use scores were obtained. Five patients discontinued opioids, 7 continued to use them, and 4 began use.

Pauza et al., (2004) reported a randomized, placebo-controlled, prospective trial of IDET (3). Of 64 enrolled patients, 37 were treated by IDET and 27 by sham treatment. Patients in both groups showed improvement; however mean improvements in pain, disability and depression were significantly greater in patients treated with IDET. The investigators are the developers of the technology and they have a financial investment in Oratec, the developer of the device, now owned by Smith & Nephew.

A small, double-blind, randomized, controlled trial by Kapural et al., (2005) comparing IDET (n=38) to sham catheter (n=19) found that six months after treatment, neither group had experienced statistically significant improvement from baseline. The investigators concluded that IDET was safe, but not demonstrably better than placebo. Another small, double-blind, randomized, controlled trial comparing IDET (n=37) to sham treatment (n=27) reported that patients in both groups exhibited improvement, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. A prospective, matched, controlled trial comparing IDET (n=21) versus radiofrequency (n=21) demonstrated significant improvement in both groups one year after treatment with improvement being greater in the IDET group.

Tsou et al., (2004) (n=113) reported excellent results in 15% of patients, good results in 28%, fair results in 30% and poor results in 27%.

In a case series (n=33) by Bryce et al., statistically significant improvement of pain and functional capacity was strongly associated with female gender and age. Males did not retain significant improvement beyond six months.

The objective of this meta-analysis by Appleby et al., (2006) was to determine the representative outcomes of the intradiscal electrothermal therapy (IDET) procedure in terms of pain relief, reduction of disability, and risk of complications. The outcomes analyzed were the visual analog scale (VAS) assessment of pain, the bodily pain, and physical functioning subscales of the SF-36 health survey, and the Oswestry disability index. From 1998 to March 2005,

Discogenic Pain, Treatment - Commercial Medical Management Guideline

62 peer-reviewed articles were identified regarding the IDET procedure. The authors concluded that although variation exists in the reported outcomes among the various studies of the IDET procedure, the pooled results of the published studies provide compelling evidence of the relative efficacy and safety of the IDET procedure. However, the studies that were included in this meta-analysis used subjective evaluation of improvement as key outcome measures.

In a study reported by Cohen et al., (2007) nine consecutive patients with discogenic low back pain who obtained excellent pain relief from intradiscal electrothermal therapy were treated with a repeat procedure after the beneficial effects had diminished. Although 4 of 9 patients obtained or =50% pain relief and were satisfied with the results, both the degree and duration of benefit were less pronounced than after the first procedure. Prospective studies are needed to identify the best candidates for repeat intradiscal electrothermal therapy.

A systematic review by Urrutia et al., (2007) included six studies with a total of 283 patients. Two open, nonrandomized trials (95 patients) showed positive results for IDET compared with rehabilitation and percutaneous intradiscal radiofrequency therapy (PIRFT). Results from 2 RCTs showed no differences between PIRFT and placebo, and between different PIRFT techniques. Two RCTs compared IDET with placebo. One suggested differences only in pain and in disability, while the best quality RCT showed no differences. The authors concluded that the available evidence does not support the efficacy or effectiveness of percutaneous thermocoagulation intradiscal techniques for the treatment of discogenic low back pain.

There are no published RCTs assessing Coblation (ArthroCare Spine, Stockholm, Sweden) technology. (Freeman, 2008) National Institute for Health and Clinical Excellence (NICE): NICE evaluated percutaneous intradiscal electrothermal therapy for lower back pain in 2004 and concluded that evidence was insufficient to support the use of this procedure without special arrangements for consent and for audit or research.

Professional Societies American Society of Interventional Pain Physicians (ASIPP): Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain (2007) The American Society of Interventional Pain Physicians (ASIPP) has prepared practice guidelines, and found that the evidence for intradiscal electrothermal therapy (IDET) is moderate in managing chronic discogenic low back pain. (Boswell, 2007) Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT) Ercelen et al. (2003) conducted a prospective randomized trial evaluating the efficacy of percutaneous intradiscal radiofrequency thermocoagulation in 39 patients. Patients were randomly selected and divided into two groups. In the first group, treatment was performed for 120 seconds and in the second group for 360 seconds, both at 80C. Evaluations were performed before, immediately after treatment, at 1 and 2 weeks, and at 1, 3, and 6 months after the procedure.

There were no statistical differences in pain relief and functional improvement between two groups. The immediate, 1week and 2- week, and 1-month visual analogue scale (VAS) scores were decreased significantly in both groups when comparing them with the pretreatment scores. However, the final values after 6 months were similar to those measured at the beginning of the study. The authors concluded that percutaneous intradiscal radiofrequency thermocoagulation has been suggested and performed to relieve discogenic pain. In the previous controlled study, no effective pain relief has been obtained. In this study, the authors increased the duration of radiofrequency thermocoagulation to improve the effectiveness of this method. Yet, the authors have not found any significant differences between the application of lesioning at two different times in percutaneous intradiscal radiofrequency thermocoagulation.

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