«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»
• for further evaluation of demonstrably abnormal discs when required to assess the extent of the abnormality or correlation of the abnormality with clinical symptoms
• for patients with persistent, severe symptoms in whom other diagnostic tests have failed to reveal clear confirmation of a suspected disc as the source of pain
• for assessment of patients who have failed to respond to previous surgical interventions (i.e., to detect pseudoarthrosis or a symptomatic disc in a posteriorly fused segment and to evaluate for recurrent disc herniation)
• for assessment of discs before fusion
• for assessment of minimally invasive surgical candidates to confirm a contained disc herniation or to investigate dye distribution pattern before chemonucleolysis or other percutaneous procedures Interventional Techniques in the Management of Chronic Spinal Pain: Evidence-based Practice Guidelines: The evidence for cervical and thoracic discography is limited. The evidence for lumbar discography was strong for discogenic pain provided that lumbar discography is performed based on the history, physical examination, imaging data, and analysis of other precision diagnostic techniques. There is no evidence to support discography without other non-invasive or less invasive modalities of treatments or other precision diagnostic injections. (Manchikanti, 2003) Washington State Health Care Authority: In the Health Technology Assessment (HTA) prepared by ECRI Institute October 2007 on Spinal Fusion and Discography for Chronic Low Back Pain and Uncomplicated Lumbar Degenerative Disc Disease, the role of lumbar discography in the selection of patients as surgical candidates is controversial. Part II of the report evaluated evidence concerning the role of discography prior to lumbar fusion. Washington State Health Care Authority concluded that the evidence was insufficient to permit conclusions about the reliability of discography for patients with chronic low back pain and uncomplicated lumbar degenerative disc disease. (WSHCA, 2007) Because of low quality and heterogeneous results from three studies (n = 330 patients), the evidence was insufficient to permit conclusions about the use of discography to predict fusion outcomes in patients with chronic low back pain and uncomplicated lumbar degenerative disc disease. No evidence of acceptable quality was available to address this question; thus, the evidence was insufficient to permit conclusions about the influence of discography on fusion outcomes in patients Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline with chronic low back pain and uncomplicated lumbar degenerative disc disease.
Epidural Lysis of Adhesions Heavner et al. performed an early RCT that evaluated 4 variations of percutaneous epidural adhesiolysis (Heavner, 1999). For this study, 59 patients were randomized to and completed adhesiolysis with or without hypertonic saline and with or without hyaluronidase. All treatment groups had similar outcomes, both at discharge and at 12 months follow-up. For instance, pain scores at discharge were decreased at least 3 points on a 10-point scale in 80% to 88% of patients in every treatment group; however, approximately 70% of patients underwent 1 or more additional treatments such as repeat adhesiolysis, lumbar facet injection, hypogastric plexus blocks, muscle injections, nerve root injections, or spinal cord stimulation. The mean time between adhesiolysis and the first additional treatment was approximately 2.3 months for all groups. This study did not include a conservatively treated control group and there was a financial conflict-of-interest for one of the investigators.
Trescot et al. conducted a systematic review utilizing the methodologic quality criteria of the Cochrane Musculoskeletal Review Group for randomized trials and the criteria established by the Agency for Healthcare Research and Quality (AHRQ) for evaluation of randomized and nonrandomized trials (Trescot, 2007). This was done to evaluate and update the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis in managing chronic low back and lower extremity pain due to radiculopathy, with or without prior lumbar surgery, since the 2005 systematic review. The primary outcome measure was significant pain relief (50% or greater). Other outcome measures were functional improvement, improvement of psychological status, and return to work. Short-term relief was defined as less than 3 months, and long-term relief was defined as 3 months or longer. The evidence from the previous systematic review was combined with new studies since November 2004. The authors concluded that there is strong evidence for short-term and moderate evidence for long-term effectiveness of percutaneous adhesiolysis and spinal endoscopy.
Sakai et al. evaluated the effect of adhesiolysis followed by the injection of steroid and local anesthetic during epiduroscopy on sensory nerve function, pain, and functional disability in patients with chronic sciatica in 19 patients with chronic sciatica refractory to lumbar epidural block (Sakai, 2008). At all frequencies, the current perception threshold (CPT) values in the affected legs of patients before the epiduroscopy were significantly higher than those in the unaffected legs. Epidural adhesiolysis was successfully performed in 16 of the 19 patients. In these patients, the CPT values at 2000 and 250 Hz, and the pain and RMDQ scores 1 and 3 months after the epiduroscopy were significantly lower than those before the epiduroscopy, while the CPT value at 5 Hz did change. The authors concluded that epidural adhesiolysis followed by the injection of steroid and local anesthetic during epiduroscopy alleviated pain, and functional disability, and reduced dysfunction of Abeta (the largest in diameter and fastest in sensory conduction of the sensory nerve fibers) and Adelta (smaller in diameter and slower in sensory conduction than A-beta sensory nerve fibers) fibers in patients with chronic sciatica.
Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline In a literature review by Racz et al., primary sources of information included: (1) 2 systematic literature reviews that include literature published through September 2006; (2) expert opinions; and (3) peer-reviewed publications from September 2006 to January 2008 (Racz, 2008). The focus was on percutaneous entry using catheters via the sacral hiatus to treat pain in the lumbosacral region.
The evidence is strong for short-term efficacy (3 months) and moderate for long-term efficacy (greater than 3 months). Complications do occur, but there is limited literature that documents incidence. The authors concluded that the cumulative evidence through January 2008 showed that percutaneous adhesiolysis with targeted drug delivery is an effective treatment for LBP and/or radiculopathy.
Another study of percutaneous epidural adhesiolysis by Manchikanti et al. evaluated this treatment in comparison with conservative, noninvasive treatments for chronic, severe low back pain (Manchikanti, 2001). This study was a quasi-RCT since the 45 patients were assigned to treatment groups based on patient preference and/or insurance coverage of adhesiolysis. For this study, adhesiolysis was combined with epidural injection of steroid and hypertonic saline. Although patient outcomes were assessed over an 18-month period, the true length of follow-up (time elapsed after the final treatment) was not reported and patients assigned to adhesiolysis underwent a mean of 5.8 full adhesiolysis procedures. At the final assessment, the 30 patients who underwent adhesiolysis had a 49% decrease in mean pain score, 42% increase in mean physical health score, 71% increase in mean functional status score, and 52% increase in mean mental health score. All of these improvements were statistically significant compared with conservative treatment, which provided a 10% decrease in mean pain score and no improvement in the other three measures. Compared with conservative treatment, adhesiolysis was also associated with statistically significant improvements in heavy narcotic use. However, these seem to be short-term benefits since the mean duration of 50% or more of pain relief was only 2.1 months after treatment or retreatment.
Manchikanti et al. conducted another study on 75 patients who were randomized into 3 treatment groups (Manchikanti, 2004). Three types of interventions were included, with Group I serving as control with catheterization without adhesiolysis, followed by injection of local anesthetic, normal saline, and steroid. Group II consisted of catheterization and adhesiolysis, followed by injection of local anesthetic, normal saline, and steroid. Group III consisted of adhesiolysis followed by injection of local anesthetic, hypertonic saline, and steroid. Visual Analogue Scale pain scores, Oswestry Disability Index, work status, opioid intake, range of motion measurement, and P-3 was utilized to measure outcomes. Significant pain relief was defined as average relief of 50% or greater. Significant improvement was seen in patients in Group II and III, at 3 months, 6 months, and 12 months, compared to baseline measurements, as well as compared to Group I without adhesiolysis. Seventytwo percent of patients in Group III, 60% of patients in Group II, compared to 0% in Group I showed significant improvement at 12-month follow up. The average number of treatments was 2.1 to 2.8 to obtain the improvements reported. Duration of improvement after the initial treatment was 2.8 +/months in Group II and 3.8 +/- 3.37 months in Group III. The authors concluded that Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline percutaneous adhesiolysis, with or without hypertonic saline neurolysis, is an effective treatment for chronic low back pain.
Veihelmann et al. conducted a study of 99 patients with chronic lower back pain and sciatica to investigate whether minimally invasive techniques for adhesiolysis are superior to conservative treatment with physiotherapy (Veihelmann, 2006). Patients were randomly assigned into either a group with physiotherapy (n=52) or a group undergoing epidural neuroplasty (n=47). Patients were assessed before and 3, 6, and 12 months after treatment by a blinded investigator. After 3 months, the visual analog scale (VAS) score for back and leg pain, was significantly reduced in the epidural neuroplasty group, and the need for pain medication was reduced in both groups. Furthermore, the VAS for back and leg pain as well as the Oswestry disability score were significantly reduced until 12 months after the procedure in contrast to the group that received conservative treatment. The authors concluded that epidural neuroplasty results in significant alleviation of pain and functional disability in patients with chronic low back pain and sciatica based on disc protrusion/prolapse or failed back surgery on a short-term basis as well as at 12 months of follow-up. However, a serious shortcoming of this study is that 13 (25%) of the patients who underwent physical therapy were not available for follow-up at 3 months due to refusal of re-evaluation (n=10) or treatment with open discectomy (n=3). Pain and disability were assessed at 6 and 12 months in patients who remained in the study; however, it is difficult to interpret these data since 12 (23%) of the patients who underwent physical therapy chose to undergo epidural adhesiolysis and they were also excluded from the study.
For patients who underwent adhesiolysis as their initial treatment, improvements were relatively stable over time. Specifically, mean disability score was 54% better at 3 months versus 50% better at 12 months and mean leg and back pain scores were 67% to 68% better at 3 months versus 61% better at 12 months. Parallel improvements were observed in a measure of analgesic use but the statistical significance of change in this outcome measure was not reported.
Manchikanti et al. randomized 83 patients with chronic lower back pain to adhesiolysis with steroid injection (n=50) or steroid injection alone (n=33) (Manchikanti, 2005). These patients had failed to obtain significant relief with conservative treatments including percutaneous adhesiolysis. During this study, patients were not allowed to undergo a second adhesiolysis or other procedure.
Endoscopic adhesiolysis was associated with statistically significant improvements in all outcome measures at 12 months follow-up. For instance, mean pain score was 37% lower for patients who underwent adhesiolysis versus 3% lower for patients who only underwent steroid injection, a statistically significant difference. Improvements were also seen in measures of functional improvement. A 31% improvement in mean Oswestry disability score was seen 12 months after adhesiolysis versus a 3% improvement after steroid injection alone. Similarly, 41% to 86% improvements were seen in three measures of spinal range-of-motion after adhesiolysis versus 5% worsening to 12% improvement for the steroid injection Control Group. For assessments of depression, anxiety, and somatization, mean scores were 14% to 16% lower after adhesiolysis versus 1% higher to 2% lower after steroid injection alone. In addition, employment increased from 2% at baseline to 32% at 12 months after adhesiolysis versus no change after steroid injection alone. An Epiduroscopy, Epidural Lysis of Adhesions and Functional Anesthetic Discography- Commercial Medical Management Guideline analysis of 50% or more of pain relief over time indicated that the average duration of this benefit was 7.6 to 4.7 months. The average duration of other improvements was not reported. A significant shortcoming of this study is that 33 (40%) patients were not available for follow-up at 12 months.