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Kapural et al. (2005) performed a prospective matched controlled trial of intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for treatment of discogenic pain. They matched 42 patients with 21 having IDET and 21 having radiofrequency annuloplasty. They reported the IDET group had significantly lower mean pain scores than the radiofrequency annuloplasty group however; there was improvement noted in both groups. VAS pain scores decreased from 6.6 + 2.0 before to 4.4 + 2.4 at one year after radiofrequency annuloplasty, whereas in IDET group the average VAS Discogenic Pain, Treatment - Commercial Medical Management Guideline pain score decreased from 7.4 + 1.9 before IDET to 1.4 + 1.9 at 1-year follow-up. Similarly, pain disability index scores in the IDET group had a significantly larger improvement than those for patients who received radiofrequency annuloplasty.
Finch et al (2005) studied 31 patients by heating of their annular tears with a flexible radiofrequency electrode placed across the posterior annulus and compared 15 patients with conservative management. The visual analog scale decreased significantly after the radiofrequency treatment and this decrease persisted at 12 months follow-up. The VAS did not change over 12 months in untreated controlled subjects. The Oswestry Disability Index also decreased in treated patients but not in controlled subjects.
Barendse et al. (2001) reported on a double-blind trial that randomized 28 patients with chronic low back pain to undergo PIRFT or a sham procedure. The primary outcome was the percentage of success at eight week, as measured by changes in pain level, impairment, Oswestry Disability Scale, and analgesics taken. At the end of the eight weeks, there were two treatment successes in the sham group compared to one in the treatment group. The authors concluded that PIRFT was not better than placebo procedure in reducing pain and disability.
Urrutia et al. (2007) conducted a systematic review to evaluate the evidence for the percutaneous thermocoagulation intradiscal techniques IDET and PIRFT in the treatment of discogenic low back pain. Six studies with a total of 283 patients were included. Two randomized controlled trials, including the Barendse trial described above, showed no differences between PIRFT and placebo and between different PIRFT techniques. The authors stated that, although previous case reports and nonrandomized trials suggested positive results, results from randomized clinical trials show that PIRFT is not effective for the treatment of discogenic low back pain.
National Institute for Clinical Excellence (NICE): NICE evaluated the safety and efficacy of percutaneous intradiscal radiofrequency thermocoagulation for lower back pain and concluded that the evidence does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. (NICE, Interventional Procedures Percutaneous intradiscal thermocoagulation for lower back pain, 2004) Professional Societies American Society of Interventional Pain Physicians (ASIPP): Interventional Techniques: Evidence-based Practice Guidelines in the Management of Chronic Spinal Pain: The ASIPP has prepared practice guidelines, and found that the evidence for radiofrequency posterior annuloplasty was limited for short- term improvement, and indeterminate for long-term improvement in managing chronic discogenic low back pain. (Boswell, 2007) Nucleoplasty Sharps and Isaac (2002) conducted a prospective, single site study that evaluated 49 consecutive patients with complaints of back pain with or without leg pain secondary to a contained focal protrusion. Success was defined as a minimum 2point reduction on a Visual Analog Scale (VAS), patient satisfaction, absence of narcotic use, and return to work if not working secondary to back pain. The pre-procedure and post- procedure VAS differences were 4.28, 4.66, 4.75, and 3.3 at the one-month, 3- month, 6-month, and 12-month intervals respectively. Overall, there was a 79% success rate, with 67% success in the group of patients that had previous surgery and 82% success in the group that had no prior surgical intervention.
Cohen et al., (2003) conducted a nonrandomized controlled trial that evaluated IDET as an adjunct to nucleoplasty for lumbar disc herniations. A total of 7 patients underwent nucleoplasty alone (Nucleoplasty Group) and 9 patients underwent nucleoplasty combined with IDET (IDET Group). Patients were assigned to the IDET Group if they had sitting intolerance, degenerative disc disease on MRI, and concurrent axial discogenic pain during provocative discography. At a mean follow-up of 9 months, mean pain scores had decreased from 6.0 2.0 to 4.8 1.8 in the Nucleoplasty Group and from 7.2 1.8 to 6.3 1.0 in the IDET Group. Using = 50% pain relief as the definition of clinical
Discogenic Pain, Treatment - Commercial Medical Management Guideline
success, only 1 (6%) patient had a successful procedure. Due to the poor results obtained, Cohen et. al. (2005) recommended that future clinical trials enroll patients who have herniations 6 mm, annular integrity confirmed by CT discography, and radicular symptoms confirmed by nerve blocks or neurological studies.
Singh et al., (2003) in a prospective, nonrandomized cohort analysis, demonstrated an improvement in the pain scores of 76 to 82% of 80 patients at 1,3,6, and 12 months after nucleoplasty. Improvements in sitting, standing and walking ability were achieved in 54%, 44%, and 49% of patients, respectively.
The largest available controlled trial of nucleoplasty was performed by Nardi et al., (2005) who assigned 50 patients to nucleoplasty and 20 patients to conventional therapy with anti-inflammatory medications and physical therapy. Unlike most of the other available studies of nucleoplasty, this trial enrolled patients who had herniated or protruding cervical discs rather than damaged lumbar discs. At 60 days post-treatment, complete resolution of cervical and radicular pain was reported by 40 (80%) Nucleoplasty Group patients and by 4 (20%) Conventional Group patients. MRI findings at 4 months after nucleoplasty appeared to correlate with clinical resolution. In contrast, no spontaneous regression of disc herniation was observed in MRI exams of patients in the Conventional Group. Nardi et al. reported that clinical improvements were statistically significant in the Nucleoplasty Group but not in the Conventional Group; however, these investigators do not appear to have performed an intergroup analysis.
The largest available uncontrolled study of nucleoplasty was performed by Alexandre et.al. (2005) who assessed outcomes for 1390 patients treated for lumbalgia or lumbosciatica due to disc bulging or partially contained disc herniation. Alexandre et al. reported few details of demographics and no information concerning fraction of patients lost to follow-up. Based on Japanese Orthopedic Association scores, at 1 year of follow-up, improvements were excellent for 56% of patients, good for 25%, scanty for 12%, and none for 7%. No clear trend was observed when outcomes at 15 days, 1 month, 6 months, and 1 year were compared. Findings on MRI and/or CT at 6 months after nucleoplasty showed the elimination of disc bulging in 34% of patients, a reduction in 48%, and no change in 18%.
Marin (2005) reported on 64 patients treated with nucleoplasty for discogenic low back and/or leg pain. Improvements in pain scores were recorded in 76% to 83% of patients at all follow-ups to 12 months.
Bhagia et al., (2006) reported the short-term side effects and complications after percutaneous disc decompression utilizing coblation technology (Nucleoplasty) in a retrospective study on 53 patients. The authors reported statistically significant reductions in VAS scores for both back and leg pain. The procedure was associated at 24 hours with shortterm increased pain at the needle insertion site (76%), new numbness or tingling (26%), increased preprocedure back pain (15%) and new areas of back pain (15%). By 2 weeks no patients had soreness at injection site or new areas of back pain, and only 2 had increased intensity of preprocedure back pain, while new numbness or tingling was present in 15% of patients.
In a prospective, non-randomized, longitudinal, cohort study, Gerszten et. al., (2006) assessed pain, functioning, and quality of life (QOL) in 67 patients with radicular leg and back pain who underwent Nucleoplasty- based percutaneous disc decompression. Pain relief, functioning, and quality of life (QOL) were evaluated. Patients completed the Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, EuroQol 5D (EQ5D), and a VAS for pain preoperatively, and at 3 and 6 months after surgery. Compared with pre-operative QOL, there was a statistically significant improvement in QOL at 3 months as measured using the SF-36 Physical Component Summary (PCS) scale, the EQ5D and the VAS for pain. Six-month results in 36 patients continued to reflect improvement as measured using the SF-36 PCS and the EQ5D.
The authors concluded that Nucleoplasty-based percutaneous disc decompression in patients with symptomatic contained disc herniations is safe and improves QOL as measured by the SF-36, EQ5D, and VAS for pain, three generic QOL outcome instruments. Nucleoplasty is an effective minimally invasive surgical treatment alternative in patients with symptomatic contained disc herniations. They noted that further follow-up evaluation is underway to determine the durability of QOL improvement after Nucleoplasty.
Discogenic Pain, Treatment - Commercial Medical Management Guideline
The largest improvement in mean VAS score was reported in this follow-up study by Masala et al., (2007) who treated 72 patients affected by lumbar disk herniation were treated with nucleoplasty coblation. Average preprocedural pain level for all patients was 8.2, while the average pain level at 12 months follow-up was 4.1. At the 1 year evaluation, 79% of patients demonstrated a statistically significant improvement in numeric pain scores: 17% (12 patients) were completely satisfied with complete resolution of symptoms, and 62% (43 patients) obtained a good result. a decrease from 8.2 at baseline to 4.1 (4.1 points) at 1-year follow-up.
Mirzai et al., (2007) evaluated outcomes 2 weeks, 6 months, and 1 year after nucleoplasty in 52 consecutive patients with leg pain and MRI evidence of small and medium-sized herniated discs. Thirty-four patients had one and 18 had two discs treated; a total of 70 procedures were performed. Mean VAS reduced from preprocedure 7.5 to 3.1 at postprocedure 6 months and to 2.1 at the latest follow-up. Mean Oswestry index decreased from 42.2 to 24.8 at 6 months and to 20.5 at the latest examination. Analgesic consumption was stopped or reduced in 42 patients (85%) at 6 months and in 46 patients (94%) 1 year after the procedure. Overall patient satisfaction was 81% at 2 weeks, 85% at 6 months, and 88% at the latest follow-up.
Yakovlev et al., (2007) treated 22 patients with radicular or axial low back pain secondary to contained herniated discs with nucleoplasty. Reported pain and medication use were significantly decreased and functional status was improved at 1, 3, 6, and 12 months following nucleoplasty for all outcome measures at all time periods.
Technology Assessment Hayes: Disc Nucleoplasty® (ArthroCare-D® SpineWand) for Percutaneous Disc Decompression (12/2007) Evidence evaluated for this report was obtained by a literature search from 2000 through December 2007. The report concluded that the literature search identified two nonrandomized controlled trials and ten uncontrolled case series that evaluated nucleoplasty. Results of these studies provide preliminary evidence that nucleoplasty is a safe and effective treatment for patients who have small herniations or protrusions of spinal discs. However, most of this evidence comes from uncontrolled studies and all of the available studies assessed results of nucleoplasty for less than one year after treatment. Therefore, the efficacy of nucleoplasty relative to other treatments for disc disease has not been established and the durability of improvements after nucleoplasty has not been investigated adequately. Further controlled studies with long-term measurement of pain and physical function are needed to establish the efficacy of disc nucleoplasty.
National Institute for Health and Clinical Excellence (NICE): NICE evaluated percutaneous disc decompression using coblation for lower back pain in 2006 and concluded that there was some evidence of short-term efficacy; however it 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 clinical effectiveness of nucleoplasty is moderate for short-term and limited to long-term relief. (Boswell, 2007) Automated percutaneous lumbar discectomy (APLD) Percutaneous, radiographically visualized procedures include automated and manual techniques, using forceps, automated suction/cutting devices, and lasers to remove disc material. There were three studies that evaluated automated percutaneous lumbar discectomy, a procedure that involves insertion of a mechanical probe, which cuts herniated disc material and removes this material by suction. Chatterjee et al. (1995) conducted a randomized controlled trial to compare automated percutaneous lumbar discectomy (APLD) with microdiscectomy in 71 patients. In the original study design, the recruitment goal was 160 patients. However, when interim analysis found that results with APLD were inferior to microdiscectomy, further recruitment of subjects to the APLD treatment arm was halted. Of the 31 patients
Discogenic Pain, Treatment - Commercial Medical Management Guideline
treated with APLD, 9 (29%) had a successful outcome, while 32/40 (80%) patients treated with microdiscectomy had a successful outcome. Grevitt et al. (1995) studied the safety and efficacy of APLD in 115 of 137 patients for whom longterm data was available. Excellent to good results were noted in 45% of this group, although approximately 30% of the patients who were initially rated as successful had deterioration in symptoms and increased disability from back pain at long-term follow-up.