Intradiscal Electrothermal Therapy Research Articles

Minimal-invasive pain procedures are effective in different degenerative pain generators in CLBP: A prospective cohort study.

It is estimated that a significant number of spinal surgeries are performed, but many patients do not often benefit. Our aim was to determine how effective minimally invasive pain procedures (MIP) are in chronic low back pain (CLBP) patients with proven degenerative causes (specific low back pain). 386 eligible patients with CLBP/sciatica resistant to conservative therapy and scheduled for open surgery were screened, and 167 could be enrolled in this study. Indications for MIP in the remaining 150 individuals were made by one experienced spinal surgeon. Before and 6 months after the intervention, the numeric rating scale (NRS) and Oswestry Disability Index (ODI) were recorded. MIP was performed, such as radiofrequency of the facet and SI-joint, intradiscal electrothermal therapy in case of discogenic pain, as well as epidural neuroplasty in patients with disc herniation/epidural fibrosis. There was a statistically significant decrease in NRS (p< 0.05), as well as a significant increase in ODI (p< 0.001) 6 months after the procedures. This was also true for the results of all different pain generators and subsequent performed procedures alone. The indication of MIP should be routinely reviewed in patients with CLBP to avoid potentially open surgery and a burden on healthcare costs.

Distinguishing CT and MR Imaging Features of Postprocedural Inflammation and Infectious Spondylodiscitis After Intradiscal Electrothermal Therapy

Distinguishing CT and MR Imaging Features of Postprocedural Inflammation and Infectious Spondylodiscitis After Intradiscal Electrothermal Therapy

Current Concepts in Intradiscal Percutaneous Minimally Invasive Procedures for Chronic Low Back Pain.

Study Design:A systemic review of thermal annular procedures (TAPs) and percutaneous disk decompression procedures (PDDPs) for the treatment of discogenic chronic low back pain (CLBP) was conducted.Objective:The objective of this review is to evaluate and to compare the effectiveness of TAPs and PDDPs in treating discogenic CLBP and to assess the frequency of complications associated with those procedures.Materials and Methods:English-language journal articles were identified through computerized searches of the PubMed database and bibliographies of identified articles and review papers. Articles were selected for inclusion if percutaneous minimally invasive procedures were the treatment options for patients with CLBP and if follow-up outcome data included evaluations of back pain severity, functional improvement, and/or incidence of complications. For this review, 27 studies were included.Results:Intradiscal electrothermal therapy (IDET) procedure in properly selected patients may eliminate or delay the need for surgical intervention for an extended period, whereas few adverse effects have been reported. In contrast to IDET, there is far less literature on the effectiveness of radiofrequency annuloplasty and intradiscal biacuplasty procedures. Nucleoplasty is a potentially effective treatment option for patients with contained disc herniation, while the procedure is well tolerated. Increased success rates have been found for percutaneous laser disc decompression and automated percutaneous lumbar discectomy in strictly selected patients.Conclusions:These procedures can be effective and may obviate the need for surgery completely. Further prospective randomized sham-controlled trials with higher quality of evidence are necessary to confirm the efficacy of these procedures.

Management of Discogenic Lumbar Pain with Intradiscal Electrothermal Therapy (IDET)

Aim: Evaluate the effectiveness of intradiscal electrothermal therapy in treating discogenic low back pain. Methods: Using three data bases (PubMed, Cochrane and Scopus) we searched for clinical studies evaluating non-operative methods of treating discogenic back pain that were published between 2004-2012. Only systematic reviews and meta-analysis were included. Inclusion criteria: included if they met the following inclusion criteria: patients were at least 18 years of age; they were written in English and involved patients with chronic non-malignant pain who had never been surgical managed, after removal of duplicate citations only 4 articles were selected. Results: The two systematic reviews and two meta-analyzes whose objective were to establish the IDET roll in the improvement of discogenic pain, did not find statistically significant evidence to recommend this treatment. Only one study established a possible improvement of discogenic pain at 6 months with acceptable evidence quality. Conclusion: The current studies provide contradictory evidence of it benefit and it remains unclear whether these interventions confer stable long-term benefit. Thus, physicians must exercise caution in recommending this treatment for patients with discogenic chronic back pain.

Management of Discogenic Lumbar Pain with Intradiscal Electrothermal Therapy (IDET)

Aim: Evaluate the effectiveness of intradiscal electrothermal therapy in treating discogenic low back pain. Methods: Using three data bases (PubMed, Cochrane and Scopus) we searched for clinical studies evaluating non-operative methods of treating discogenic back pain that were published between 2004-2012. Only systematic reviews and meta-analysis were included. Inclusion criteria: included if they met the following inclusion criteria: patients were at least 18 years of age; they were written in English and involved patients with chronic non-malignant pain who had never been surgical managed, after removal of duplicate citations only 4 articles were selected. Results: The two systematic reviews and two meta-analyzes whose objective were to establish the IDET roll in the improvement of discogenic pain, did not find statistically significant evidence to recommend this treatment. Only one study established a possible improvement of discogenic pain at 6 months with acceptable evidence quality. Conclusion: The current studies provide contradictory evidence of it benefit and it remains unclear whether these interventions confer stable long-term benefit. Thus, physicians must exercise caution in recommending this treatment for patients with discogenic chronic back pain.

Combined radiofrequency for the treatment of lumbar discogenic radiculopathy

Introduction. Intervertebral disc degeneration often is a cause of low back pain (LBP) and reactive radicular pain. Thermodiscoplasty, or intradiscal electrothermal therapy (IDET) is used for minimally invasive treatment of discogenic pain. Pulsed radiofrequency (PRF) of the dorsal root ganglion (DRG) is used as an interventional method for radicular pain elimination. Objective. To study the dynamics of pain syndrome and social adaptation in patients undergone combined treatment with the IDET and PRF DRG for chronic discogenic lumbosacral radiculopathies. Materials and methods. A retrospective analysis of 20 patients treated at the Neuromed Clinic in Kyiv and the Pain Medicine Center in Kyiv was conducted. All patients had degenerative-dystrophic disease of intervertebral discs L4–L5 and L5–S1 with L4, L5, S1, S2 radiculopathy. A standard examination included biplane spondylography, MRI, and the neurological status assessment. The character of the pain was confirmed by a provocative contrast discography, the involvement of the corresponding spinal root was established during the selective radicular blockade. The results of the treatment were assessed using the visual-analogue pain scale (VAS) and the Oswestry Disability Index (ODI). Results. No complications were found. Two patients (10 %) had unsatisfactory results in the form of a lack of positive dynamics. They underwent transforaminal endoscopic discotomy for up to 7 days. The rest of patients noted a significant reduction in pain. This tendency was keeping for 6 months. Conclusions. The combined use of IDET and PRF DRG is an effective and safe method for the treatment of chronic lumbosacral discogenic radiculopathies.

Intradiscal electrothermal therapy for chronic discogenic low back pain: a comparison of two heating protocols

Objectives. This study aims to evaluate the effect of intradiscal electrothermal therapy (IDET) applied in patients with chronic low back pain using two heating protocols. Methods. In this study, data of 50 patients who were exposed to percutaneous IDET using two heating protocols were retrospectively analyzed. The patients were divided into two groups: in Group 1 (n=25), maximum 75 0 C catheter tipping was used, while in Group 2 (n=25), maximum 90 0 C catheter tipping was performing. Pre-treatment (M0) and post-treatment results at 3 (M3), 6 (M6), 12 (M12), and 18 months (M18) were evaluated using the visual analogue acale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) scores. Results. There was no statistically significant difference in demografic characteristics and M0 VAS, ODI values and SF-36 dimensions of the patients between the groups ( p > 0.05). It was found that there were statistically significant improvement than baseline values in the M3, M6, M12, and M18 VAS, ODI, and SF-36 scores in both treatment groups ( p < 0.05). Between the group comparison; only the M18 VAS and SF-36 pain values were found statistically significant in the positive direction in Group 2 ( p < 0.05). Conclusion. Similar successful results were obtained in our study involving two different heating procedures up to 12 months of administering IDET treatment. But at the 18 th month the 90 0 C IDET seems to be more effective in improving the pain scores.

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain

Background: Discogenic low back is a distinct clinic entity characterized by pain arising from a damaged disc. The diagnosis is clouded by the controversy surrounding discography. The treatment options are limited, with unsatisfactory results from both conservative treatment and surgery. Multiple interventional therapies have been developed to treat discogenic pain, but most have not yet been validated by high quality studies. The best studied treatment for discogenic pain is the use of heat, which has been labeled as thermal intradiscal procedures (TIPs) by the Centers for Medicare and Medicaid Services (CMS). As the pathology is located in the annulus, we use the term thermal annular procedures (TAPs). Objectives: The aim of this study is to evaluate and update the efficacy of TAPs to treat chronic refractory discogenic pain. Study Design: The design of this study is a systematic review. Methods: The available literature on TAPs in treating chronic refractory discogenic pain was reviewed. The quality of each article used in this analysis was assessed. The level of evidence was classified on a 5-point scale from strong, based upon multiple randomized controlled trials (RCTs) to weak, based upon consensus, as developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2015 and manual searches of the bibliographies of known primary and review articles. The primary outcome measures were pain relief and functional improvement of at least 40%. Short-term efficacy was defined as improvement for less than 6 months; long-term efficacy was defined as improvement for 6 months or more. Results: For this systematic review, 49 studies were identified. Of these, there were 4 RCTs and no observational studies which met the inclusion criteria. Based upon 2 RCTs showing efficacy, with no negative trials, there is Level I, or strong, evidence of the efficacy of biacuplasty in the treatment of chronic, refractory discogenic pain. Based upon one high-quality RCT showing efficacy and one moderate-quality RCT interpreted as showing no benefit, there is Level III, or moderate, evidence supporting the use of intradiscal electrothermal therapy (IDET) in treating chronic, refractory discogenic pain. The evidence supporting the use of discTRODE is level V, or limited. Conclusion: The evidence is Level I, or strong, that percutaneous biacuplasty is efficacious in the treatment of chronic, refractory discogenic pain. Biacuplasty may be considered as a first-line treatment for chronic, refractory discogenic pain.The evidence is Level III, or moderate, that IDET is efficacious in the treatment of chronic, refractory discogenic pain. The evidence is Level V, or limited, that discTRODE is efficacious in the treatment of chronic, refractory discogenic pain.

The effect of intradiscal electrothermal therapy to quality of life and satisfaction of patients in discogenic low back pain

The effect of intradiscal electrothermal therapy to quality of life and satisfaction of patients in discogenic low back pain

Patient selection and efficacy of intradiscal electrothermal therapy with respect to dallas discogram score

Intervertebral disc degeneration can cause severe low back pain. Intradiscal electrothermal therapy (IDET) is a minimally invasive treatment option for patients with symptomatic internal disc disruption unresponsive to conservative medical care. We aimed to evaluate 12-month pain and functional outcomes and predictors of clinical success in patients with discogenic back pain treated with IDET with respect to the Dallas Discogram Scale (DDS). This was a retrospective analysis of patients undergoing IDET for low back pain from 2009 through 2014 at Baskent University, Department of Neurosurgery. A total number of 120 consecutive patients data were collected retrospectively. The degree of disc degeneration was graded using the DDS during discography, and the presence of a high intensity zone (HIZ) on magnetic resonance (MR) imaging was noted. The primary outcome measure was assessment of back pain severity based on the Visual Analogue Scale (VAS); function was assessed by the Oswestry Disability Index (ODI). Follow-up examinations for ODI and VAS scores were assessed at 1, 6, and 12 months post-treatment. Outcomes were discussed with respect to morphological changes in intervertebral discs on discogram. There was an average 57.39% and 47.16% improvement in VAS and ODI scores, respectively, between pretreatment and 12 months follow-up (p < 0.0001 for both comparisons). Predictors of 12-month clinical success was depended on DDS (p < 0.0001), a HIZ on MR imaging (p < 0.0001). Durable clinical improvements can be realized after IDET in select surgical candidates with mild disc degeneration and HIZ, discography, and low-grade DDS, with more effective treatment results.

Comparison of open surgical discectomy versus plasma-laser nucleoplasty in patients with single lumbar disc herniation.

Background:Intervertebral disc herniation is a major cause of low back pain. Several treatment methods are available for lumbar disc herniation including Chemonucleolysis, open surgery, nucleoplasty, laser disc decompression, and intradiscal electrothermal therapy. The high prevalence of lumbar disc herniation necessitates a minimally invasive yet effective treatment method. In this study, we compared the outcomes of open surgery and nucleoplasty method in patients with single lumbar disc herniation.Materials and Methods:This study was a noninferiority randomized clinical trial conducted in one of the University Hospitals of Isfahan Medical University; The Alzahra Hospital. About 200 patients with the diagnosis of lumbar disc herniation were recruited and were assigned to either the treatment or control groups using block randomization. One group received open surgery and the other group received nucleoplasty as the method of treatment. Patients were revisited at 14 days, 1, 2, 3 months, and 1-year after surgery and were assessed for the following variables: Lower back pain, lower limb pain, common complications of surgery (e.g., discitis, infection and hematoma) and recurrence of herniation.Results:The mean (standard deviation) severity of low back pain was reduced from 6.92 (2.5) to 3.43 (2.3) in the nucleoplasty group (P = 0.04) and from 7.5 (2.2) to 3.04 (1.61) in the discectomy group (P = 0.73). Between group difference was not statistically significant (P = 0.44), however, time and treatment interaction was significant (P = 0.001). The level of radicular pain evaluated 1 year after treatment was reduced from 8.1 (1.2) to 2.9 (1.2) (P = 0.004) and from 7.89 (2.1) to 3.6 (2.5) (P =0.04) in the discectomy and the nucleoplasty groups respectively, significant interaction between time and treatment options was observed (P < 0.001) while there was no significant difference between two treatment groups (P = 0.82).Conclusion:Our results show that while nucleoplasty is as effective as open discectomy in the treatment of lumbar disc herniation, it is also less invasive with higher patient compliance. Taking factor such as decreased cost and duration of the surgery, as well as faster recovery in patients into account; we suggest considering nucleoplasty as an effective method of treatment in patients with single-level disc herniation.

Nonoperative management of discogenic back pain: a systematic review.

Systematic review of the literature. A systematic evaluation of the literature was performed to investigate current nonoperative management of the treatment of discogenic low back pain. Back pain is a major health care concern with up to 39% being discogenic in origin according to one study. Nonoperative therapy is likely to be the initial treatment strategy for discogenic low back pain. PubMed, EMBASE, and Cochrane Central Register of Controlled Trials were searched for clinical studies evaluating nonoperative methods of treating discogenic back pain that were published between 2000 and 2012. Only prospective randomized controlled studies that compared a nonsurgical intervention with sham or placebo therapy were included. After removal of duplicate citations, a total of 226 articles were initially identified from the search terms. From these, we identified 11 randomized controlled trials (RCTs) from which data analysis was performed. The 11 RCTs investigated traction therapy, injections, and ablative techniques. Results from 5 RCTs investigating methylene blue injection, steroid injection, ramus communicans ablation, intradiscal electrothermal therapy, and biacuplasty favored intervention over sham therapy. However, results from the study on methylene blue injections have not been replicated in other RCTs. Evaluation of the selection criteria used in the studies on ramus communicans ablation and intradiscal biacuplasty and a stratified analysis of results from the RCTs on intradiscal electrothermal therapy casts doubt on whether the conclusions from these RCTs can be applied to the general patient population with discogenic pain. There are few high-quality studies evaluating nonoperative treatments for reducing discogenic low back pain. Although conclusions from several studies favor intervention over sham, it is unclear whether these interventions confer stable long-term benefit. There is some promise in newer modalities such as biacuplasty; however, more inclusive studies need to be performed.

DIAM Implantation for Degenerative Disc Disease

Introduction Lumbar disc degeneration (LDD) is among the most common causes of low back pain. Typical symptoms include axial low back pain, buttock pain, with or without radiation to posterior thighs or legs, and intolerance to upright positions. Several surgical treatment options are available, including intradiscal injections, intradiscal electrothermal therapy, discectomy, total disc arthroplasty, and fusion. Recently, implantation of interspinous process devices has been shown to decrease low back pain, and provide morphological alterations of the degenerative discs, resulting in satisfactory clinical outcomes. This study was conducted to review our results of using stand-alone DIAM implantation as the treatment for symptomatic LDD. Materials and Methods A total of 24 selected cases of LDD were treated surgically with stand-alone DIAM implantation. In 20 patients, the presenting symptoms were predominantly axial low back/buttock pain with little leg pain, while in 4 patients there was only axial pain. Motor weakness and sensory disturbance involving the corresponding nerve roots were present in eight cases. Three patients had undergone previous lumbar discectomy of the afflicted discs. Typical MRI findings included loss of height, signal changes, and/or annular tear of the discs. On the basis of Pfirrmann grading scale for disc degeneration, three cases were categorized as Grade II, and 21 cases as Grade III. Our exclusion criteria included intermittent claudication due to lumbar spinal stenosis, severe disc space collapse with Modic changes, greater than Grade II spondylolisthesis, facet ankylosis, and L5-S1 pathology. Provocative test with intradiscal injection of normal saline-induced concordant pain in all cases. Results All patients reported significant symptom relief after surgery, as reflected by VAS and ODI improvements. The final outcomes were excellent in 19, good in 2, fair in 2, and poor in 1 cases. Segmental flexion/extension mobility was maintained in 20, and restricted or lost in 2, of 22 cases with preoperative mobility. In the other two cases with no preoperative mobility, DIAM implantation did not change the status. MRI was repeated in the two cases showing fair, and the one case showing poor outcomes. In all of them, enlargement of neuroforamens at the implanted levels were found. In one fair case, disappearance of annular tear was observed. In the other fair case (L4-5 implantation), L5-S1 disc herniation was disclosed, and removed in a second operation. The case with poor outcome was diagnosed with depression, having concomitant multiple joint pain, dysmenorrhea, sleep disorder, despite normal findings on different exams ordered by different specialists. Conclusion In highly selected cases with symptomatic LDD, stand-alone interspinous DIAM implantation is effective for alleviation of symptoms, and stabilization of disc status. Disclosure of Interest None declared References Sandu N, Schaller B, Arasho B, Orabi M. Wallis interspinous implantation to treat degenerative spinal disease: description of the method and case series. Expert Rev Neurother 2011;11(6):799–807 Buric J, Pulidori M, Sinan T, Mehraj S. DIAM device for low back pain in degenerative disc disease : 24 months follow-up. Acta Neurochir Suppl (Wien) 2011;108:177–182 Pfirrmann CW, Metzdorf A, Zanetti M, Hodler J, Boos N. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine 2001;26(17):1873–1878

The Role of (Intra-)Discal Treatments for Discogenic Low Back Pain

The intervertebral disc is believed to be the key pathology behind low back pain (LBP). The pain mechanisms include annular ruptures, fissures in the end plates, neural sensors on the disc surface ...

An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part II: Guidance and Recommendations

Objective: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. Methodology: Systematic assessment of the literature. Evidence: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. Anticoagulation • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There islimited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. Conclusion: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. Disclaimer: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent “standard of care.” Key words: Interventional techniques , chronic spinal pain, diagnostic blocks, therapeutic interventions, facet joint interventions, epidural injections, epidural adhesiolysis, discography, radiofrequency, disc decompression, spinal cord stimulation, intrathecal implantable systems

World Medical Leaders Declare that Pain Treatment Is a Human Right … and It Couldn't Come at a Worse Time

To be a pain specialist during these unpredictable changes in health care delivery is fraught with danger to one's professional existence. The medical management of pain has become so over-regulated by state and federal drug agencies that one step in the wrong direction can result in fines, loss of license, and even imprisonment. Attorneys now have the best possible scenario for suing physicians—if one prescribes too little pain medication or too much pain medication, one can be sued. Interventional pain specialists are constantly being challenged to produce double-blinded, randomized controlled study-equivalent data to justify their invasive procedures. Now, Centers for Medicaid & Medicaid Services (CMS) has teamed up with the Rand Corporation to examine outcome data on certain high-use, high-cost procedures to determine their cost-effectiveness. In some cases such as intradiscal electrothermal therapy (IDET) procedures for Medicare patients, CMS will not pay for the procedure based on lack of objective and positive outcome data. Thus, today's pain specialist must traverse the “Scylla and Charybdis” of multiple government agencies and aggressive attorneys in order to provide care for some of the most miserable and suffering patients in the world. In January 2011, I took part in a multinational, multidisciplinary summit in DeBilt, The Netherlands that addressed the concept of pain treatment being a human right. That's correct; a right to life, liberty, pursuit of happiness, and relief from pain and suffering. On the surface, one might think this group was a throwback to the Haight-Ashbury days of peace and love. On the contrary, world standards for effective pain relief are so varied that many terminally ill cancer patients in certain countries are denied basic opioid analgesics for palliative measures. This cause is appropriate and justified, yet also realistic as to the extent its impact may have …

Results of Intradiscal Pulsed Radiofrequency for Lumbar Discogenic Pain: Comparison with Intradiscal Electrothermal Therapy

BackgroundWe have developed an intradiscal pulsed radiofrequency (Disc PRF) technique, using Diskit II® needles (NeuroTherm, Wilmington, MA, USA), as a minimally invasive treatment option for chronic discogenic low back pain (LBP). The purpose of this study was to compare the representative outcomes of Disc PRF and Intradiscal Electrothermal Therapy (IDET) in terms of pain relief and reduction of disability.MethodsThirty-one patients with chronic discogenic LBP who underwent either Disc PRF (n = 15) or IDET (n = 16) were enrolled in the study. A Diskit II® needle (15-cm length, 20-gauge needle with a 20-mm active tip) was placed centrally in the disc. PRF was applied for 15 min at a setting of 5 × 50 ms/s and 60 V. The pain intensity score on a 0-10 numeric rating scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ) were assessed pretreatment and at 1, 3, and 6 months post-treatment.ResultsThe mean NRS was significantly improved from 7.2 ± 0.6 pretreatment to 2.5 ± 0.9 in the Disc PRF group, and from 7.5 ± 1.0 to 1.7 ± 1.5 in the IDET group, at the 6-month follow-up. The mean RMDQ also showed significant improvement in both the Disc PRF group and the IDET group at the 6-month follow-up. There were no significant differences in the pretreatment NRS and RMDQ scores between the groups.ConclusionsDisc PRF appears to be an alternative to IDET as a safe, minimally invasive treatment option for patients with chronic discogenic LBP.

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain

Background: Persistent low back pain refractory to conservative treatment is a common problem that leads to widespread impairment, resulting in significant costs to society. The intervertebral disc is a major source of persistent low back pain. Technologies developed to treat this problem, including various surgical instrumentation and fusion techniques, have not reliably provided satisfactory results in terms of either pain relief or increased function. Thermal annular procedures (TAPs) were first developed in the late 1990s in an attempt to treat discogenic pain. The hope was that they would provide greater value than fusion in terms of efficacy, morbidity, and cost. Three technologies have been developed to apply heat to the annulus: intradiscal electrothermal therapy (IDET), discTRODE, and biacuplasty. Since nerve ingrowth and tissue regeneration in the annulus is felt to be the source of pain in discogenic low back pain, when describing the 3 above techniques we use the term “thermal annular procedures” rather than “thermal intradiscal procedures.” We have specifically excluded studies treating the nucleus. TAPs have been the subject of significant controversy. Multiple reviews have been conducted resulting in varying conclusions. Study Design: A systematic review of TAPs for the treatment of discogenic low back pain. Objective: To evaluate the effectiveness of TAPs in treating discogenic low back pain and to assess complications associated with those procedures. Methods: The available literature on TAPs in treating discogenic low back pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria for interventional techniques for randomized trials, and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, or limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2011, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief of at least 6 months. Secondary outcome measures were improvements in functional status. Results: For this systematic review, 43 studies were identified. Of these, 3 randomized controlled trials and one observational study met the inclusion criteria. Using current criteria for successful outcomes, the evidence is fair for IDET and limited (or poor) for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic low back pain. Since 2 randomized controlled trials are in progress on that procedure, assessment of biacuplasty may change upon publication of those studies. Limitations: The limitations of this systematic review include the paucity of literature and nonavailability of 2 randomized trials which are in progress for biacuplasty. Conclusion: In summary, the evidence is fair for IDET and limited (or poor) for discTRODE and biacuplasty is being evaluated in 2 ongoing randomized controlled trials. Key words: Spinal pain, chronic low back pain, discogenic pain, thermal procedures, annular procedures, IDET, biaculoplasty, disctrode

Annuloplasty procedures for chronic discogenic back pain

Recently, several new minimally invasive intradiscal annuloplasty techniques for treatment of discogenic lower back pain have been introduced, but clinical evidence of their efficacy and extent of application is lagging behind. However, now we know that discTRODE annuloplasty and conventional intradiscal nuclear radiofrequency are ineffective in reducing pain and improving functional capacity. Intradiscal electrothermal therapy and intradiscal biacuplasty do produce positive therapeutic effect in an appropriately selected patient group. Based on procedural ease of radiofrequency needle placement, recent positive results from sham-randomized, prospective study, and lack of complications, biacuplasty is the only annuloplasty procedure that can be currently recommended as an appropriate minimally invasive lumbar disc annuloplasty.

Experimental Evaluation of the Risk of Extradiscal Thermal Damage in Intradiscal Electrothermal Therapy (IDET)

Background: In 2000 the intradiscal electrothermal therapy (IDET) procedure for the treatment of discogenic pain was introduced. The technique involves the positioning of an intradiscal catheter with a temperature-controlled thermal resistive heating coil at the inner posterior annulus. The therapeutic mechanism of IDET combines the thermocoagulation of native nociceptors and in-grown nonmyelinated nerve fibers with collagen shrinkage, stabilizing annular fissures. Thermal nerve root injuries were described with IDET. The temperature in relation to the distance from the catheter tip was investigated. The intradiscal temperature distribution during treatment with IDET was also described. Objective: To examine the temperature distribution outside the disc near neural structures and the risk of thermal damage to nerve tissue during a correctly performed IDET procedure. Study Design: Experimental study. Setting: Biomechanical laboratory of an academic orthopedic surgery department. Methods: Testing was performed on cadaveric human lumbar spines with 10 intact intervertebral discs in a circulating water bath. Five thermocouples were attached to different locations on the disc. The temperature was recorded for 26 minutes. In addition, surface temperatures were recorded using an infrared camera. For the application of IDET, we used the Electrothermal 20S Spine System by Smith &amp; Nephew and the standard clinical protocol. Results: The shape of the recorded temperature curves was quite heterogeneous. Inside the spinal canal, temperatures as high as 45.2°C were recorded for a very short time. Temperature monitoring with the infrared camera demonstrated a change in temperature clearly restricted to the nucleus of the disc. Limitations: The temperature distribution depends on the exact position of the IDET probe, which will never be 100% identical between individual experiments. Conclusion: This study shows that temperatures generated within the spinal canal during IDET do not appear to be high enough to cause nerve damage. Key words: IDET, thermal nerve damage, thermal complications, intradiscal electrothermal therapy