Clinical guidelines and payer policies on fusion for the treatment of chronic low back pain.
Systematic review. The purpose of this review is to provide a critical appraisal of general and fusion-specific clinical practice guidelines on the treatment of chronic nonradicular low back pain and compare the quality and evidence base of fusion guidelines and select payer policies. SUMMARY OF BACKGROUND DATA.: The treatment of lumbar spondylosis associated with low back pain with lumbar arthrodesis, or fusion, has risen fourfold in the past two decades. Given the significant associated health care costs, there is an increase in clinical guidelines and payer policies influencing patient treatment options. Assessment of the medical necessity of a treatment, such as lumbar fusions, based on medical literature will frequently supersede the determination of the physician in the care of their patient. Concerns regarding the effectiveness and costs of the surgical treatment of spinal disorders presenting with low back pain has placed enormous scrutiny on the value of surgical treatments to our patients. As both clinical guidelines and payer policies have a major impact on the perceived effectiveness, or medical necessity, of lumbar fusions for the treatment of chronic nonradicular low back pain, a review of this topic was undertaken. An electronic literature search of PubMed, the National Guideline Clearinghouse and the International Network of Agencies for Health Technology Assessment was performed to identify clinical practice guidelines on assessment and treatment of chronic nonradicular low back pain, including those on use of lumbar fusion, as well as relevant technology assessments. A Google search for publicly available private and public payer policies related to fusion was also performed. A hand search was used to identify specific studies cited for support of the recommendations made. A modified Appraisal of Guidelines Research and Evaluation instrument was used to provide a standardized assessment method for evaluating the quality of development of the evidence base and recommendations in guidelines and selected health policies. This was combined with appraisal of the evidence base supporting the recommendations. Three systematic reviews of general guidelines from a PubMed search yielding 94 citations were included. A convenience sample of five guidelines with recommendations on fusion was taken from 182 citations identified by the National Guideline Clearinghouse and the International Network of Agencies for Health Technology Assessment searches. Two guidelines were developed by US professional societies, (neurosurgery and pain management), and three were European-based guidelines (Belgium, United Kingdom, and the European Cooperation in Science and Technology). The general guidelines were consistent with their recommendations for diagnosis, but inconsistent regarding recommendations for treatment. All guidelines and payer policies with recommendations on fusion included some set of the primary randomized controlled trials comparing fusion to other treatment options with the exception of one policy. However, no clear pattern with regard to the quality of development was identified based on the modified Appraisal of Guidelines Research and Evaluation tool. There were differences in specialty society recommendations. Three systematic reviews of evidence-based guidelines that provide general guidance for the assessment and treatment of chronic low back pain described consistent recommendations and guidance for the evaluation of chronic low back pain but inconsistent recommendations and guidance for treatment. Five evidence-based guidelines with recommendations on the use of fusion for the treatment of chronic low back pain were evaluated. There is some consistency across guidelines and policies that are government sponsored with regard to development process and critical evaluation of index studies as well as overall recommendations. There were differences in specialty society recommendations. There is heterogeneity in the medical payer policies reviewed possibly due to variations in the literature cited and transparency of the development process. A description of how recommendations are formulated and disclosure of any potential bias in policy development is important. Three-medical payer policies reviewed are of poor quality with one rated as good with respect to their development based on the modified Appraisal of Guidelines Research and Evaluation tool. Medical payer policies influence patient care by defining medical necessity for approving treatments, and should be held to the same standards for transparency and development as guidelines. The spine care community needs to develop (or update) high-quality treatment guidelines. The process should be transparent, methodologically rigorous, and consistent with the Appraisal of Guidelines Research and Evaluation and Institute of Medicine recommendations. This effort should be collaborative across specialty/society groups and would benefit from patient and public input. Payer policies and treatment guidelines need to be transparent and based on the highest quality evidence available. Clinicians from specialty/society groups, guideline developers and policy makers should collaborate on their development. This process would also benefit from public and patient input.
- Research Article
42
- 10.1016/j.annemergmed.2014.11.011
- Jan 9, 2015
- Annals of Emergency Medicine
Managing Nontraumatic Acute Back Pain
- Research Article
99
- 10.36076/ppj/2016.19.e245
- Feb 14, 2016
- Pain physician
Chronic refractory low back and lower extremity pain is frustrating to treat. Percutaneous adhesiolysis and spinal endoscopy are techniques which can treat chronic refractory low back and lower extremity pain.Percutaneous adhesiolysis is performed by placing the catheter into the tissue plane at the ventrolateral aspect of the foramen so that medications can be injected. Adhesiolysis is used both for pain caused by scarring which is not resistant to catheter placement and other sources of pain, including inflammation in the absence of scarring.Mechanical lysis of scars with a catheter may or may not be necessary for percutaneous adhesiolysis to be effective. Spinal endoscopy allows direct visualization of the epidural space and has the possibility to use laser energy to treat pathology. A systematic review of the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis to treat chronic refractory low back and lower extremity pain. To evaluate and update the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis to treat chronic refractory low back and lower extremity pain. The available literature on percutaneous adhesiolysis and spinal endoscopic adhesiolysis in treating persistent low back and leg 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 to weak, based upon consensus, as developed by the U.S. Preventive Services Task Force (USPSTF) and modified by 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. Pain relief of at least 50% and functional improvement of at least 40% were the primary outcome measures. Short-term efficacy was defined as improvement of 6 months or less; whereas, long-term efficacy was defined more than 6 months. For this systematic review, 45 studies were identified. Of these, for percutaneous adhesiolysis there were 7 randomized controlled trials and 3 observational studies which met the inclusion criteria. For spinal endoscopy, there was one randomized controlled trial and 3 observational studies. Based upon 7 randomized controlled trials showing efficacy, with no negative trials, there is Level I or strong evidence of the efficacy of percutaneous adhesiolysis in the treatment of chronic refractory low back and lower extremity pain. Based upon one high-quality randomized controlled trial, there is Level II to III evidence supporting the use of spinal endoscopy in treating chronic refractory low back and lower extremity pain. The evidence is Level I or strong that percutaneous adhesiolysis is efficacious in the treatment of chronic refractory low back and lower extremity pain. Percutaneous adhesiolysis may be considered as a first-line treatment for chronic refractory low back and lower extremity pain. The evidence is Level II to III that spinal endoscopy is effective in the treatment of chronic refractory low back and lower extremity pain. Spinal pain, chronic low back pain, post lumbar surgery syndrome, epidural scarring, adhesiolysis, endoscopy, radicular pain.
- Research Article
1
- 10.56238/isevjhv3n1-006
- Jan 11, 2024
- International Seven Journal of Health Research
Low back pain is defined as any pain that occurs between the last costal arch and the lower gluteal fold, and may have different intensities and durations, being considered chronic if it lasts for more than 12 weeks, becoming non-specific if its cause is not identified, compromising the quality of life of affected individuals. Currently, Strength Training (TF) has been included in the treatment of chronic non-specific low back pain, in order to improve the condition of people suffering from this condition. Thus, the objective of this research was to verify the impact of PT on the treatment of low back pain, highlighting the main aspects based on the inclusion of this practice in everyday life, showing the benefits arising from this method. For the present study, a review of scientific articles was carried out using the PubMed, Scielo and Google Scholar databases to complement information on low back pain and PD. Several evidences were found that positively contribute to the improvement of low back pain with the use of PT in pain conditions, increased functional capacity, improvement in activities of daily living (ADL), gain in muscular resistance, strength and hypertrophy, in addition to individuals showing themselves more active. It is concluded that TF proved to be effective in the treatment of non-specific chronic low back pain, improving its symptoms such as pain and disability, however, if applied by an unqualified professional and incorrectly, it can be harmful to health.
- Supplementary Content
119
- 10.2147/jpr.s132769
- May 10, 2017
- Journal of Pain Research
Back pain is the second leading cause of disability among American adults and is currently treated either with conservative therapy or interventional pain procedures. However, the question that remains is whether we, as physicians, have adequate therapeutic options to offer to the patients who suffer from chronic low back pain but fail both conservative therapy and interventional pain procedures before they consider surgical options such as discectomy, disc arthroplasty, or spinal fusion. The purpose of this article is to review the potential novel therapies that are on the horizon for the treatment of chronic low back pain. We discuss medications that are currently in use through different phases of clinical trials (I–III) for the treatment of low back pain. In this review, we discuss revisiting the concept of chemonucleolysis using chymopapain, as the first drug in an intradiscal injection to reduce herniated disc size, and newer intradiscal therapies, including collagenase, chondroitinase, matrix metalloproteinases, and ethanol gel. We also review an intravenous glial cell-derived neurotrophic growth factor called artemin, which may repair sensory nerves compressed by herniated discs. Another new drug in development for low back pain without radiculopathy is a subcutaneous monoclonal antibody acting as nerve growth factor called tanezumab. Finally, we discuss how platelet-rich plasma and stem cells are being studied for the treatment of low back pain. We believe that with these new therapeutic options, we can bridge the current gap between conservative/interventional procedures and surgeries in patients with chronic back pain.
- Research Article
393
- 10.1097/00007632-200002151-00001
- Feb 1, 2000
- Spine
The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back Pain.
- Research Article
- 10.32385/rpmgf.v26i3.11180
- May 1, 2010
- Revista Portuguesa de Clínica Geral
Objectives: To review the available evidence on the effectiveness of acupuncture in the treatment of low back pain. Data Sources:MEDLINE, National Guideline Clearinghouse, Guidelines Finder, Cochrane Library, DARE, Bandolier, UpToDate and Index of Portuguese Medical Magazines. Review Methods: Research using the MeSH terms acupuncture and low back pain and the DeCS terms acupuntura e dor lombar. The search was limited to articles published between January 2000 and May 2009 in english, portuguese and spanish. American Family Physicians Strength of Recommendation Taxonomy (SORT) was used to assess the level of evidence. Results: Two meta-analysis, six systematic reviews, three randomised controlled trials and three guidelines met inclusion criteria. Guidelines say that acupuncture might be helpful in the treatment of low back pain. Unspecific chronic low back pain: the meta-analysis, systematic reviews and randomised controlled trials demonstrated that acupuncture is more effective than notreatment and that the association of acupuncture with conventional treatment is more effective than isolated conventional treatment. The studies didnt demonstrate that acupuncture was more effective than placebo or conventional therapies. Acute low back pain: data are inconclusive. Conclusions: Acupuncture is effective in the treatment of unspecific chronic low back pain, isolated or in addition to other interventions (SORT A); it was not proved that acupuncture was superior to other interventions. In the treatment of acute low back pain, there was no evidence of effectiveness of acupuncture. It would be advisable to do high quality, long-term, controlled and randomised studies, addressing its cost-benefit.
- Research Article
24
- 10.1007/s004820100091
- Feb 1, 2002
- Schmerz (Berlin, Germany)
Treatment for chronic low back pain in primary care has a poor-quality outcome. There is evidence that multimodal therapy is the most successful approach to its management. We tried to evaluate whether giving primary care physicians evidence-based recommendations on therapy of chronic back pain or directly implementing a multimodal program would improve the outcome of patients with low back pain treated in primary care. In the first phase, physicians were asked to document the course of patients suffering from low back pain of at least 4 weeks' duration with no decrease in intensity, noting pain intensity before and after 6 months of conventional, nonsurgical treatments. In the present, second, phase of the study, recommendations issued by the Medicines Committee of the German Medical Profession and the U.S. Agency for Health Care Policy and Research for the management of back pain were presented to doctors in printed form and at conferences. In parallel with this, a multimodal program for the treatment of chronic low back pain (4 h/day for 20 days: medical training therapy, cognitive-behavioral therapy, physiotherapy, and patient education) was organized in a private health-oriented sports center in cooperation with three private physiotherapy practices, and a psychologist and a pain specialist from the outpatient pain clinic at the University Hospital in Erlangen. We examined how physicians changed the therapy and how effective it was, the latter as reflected in the mean sum value of the percent pre- to posttreatment changes in pain intensity, how much pain interfered with daily living, depressivity, and quality of life. Data after interventions were compared with baseline data from the first phase. Data relating to 36 patients following treatment by 14 primary care physicians who had been given information about therapy recommendations and to 51 patients who had participated in the multimodal therapy program were compared with baseline data recorded in 157 patients. Recommendations changed neither the therapy preferred by primary care physicians nor the quality of outcome of conventional treatment. In contrast, the multimodal program of therapy for chronic low back pain improved the outcome significantly more than conventional therapy (mean improvement in general outcome score 22 vs. 7%, respectively, compared with baseline data; P<0.001). Giving primary care physicians information on the therapy recommended for treatment of low back pain does not lead to any change in physicians' preferred therapy. Multimodal programs for treatment of chronic low back pain should be organized locally, with existing health care providers joining forces to improve the quality of outcome in chronic low back pain managed in primary care.
- Research Article
18
- 10.1136/bmjebm-2024-112974
- Mar 3, 2025
- BMJ Evidence-Based Medicine
ObjectivesTo investigate the efficacy of non-surgical and non-interventional treatments for adults with low back pain compared with placebo.Eligibility criteriaRandomised controlled trials evaluating non-surgical and non-interventional treatments compared with placebo or...
- Research Article
94
- 10.36076/ppj.2014/17/e525
- Jul 14, 2014
- Pain Physician
Background: Chronic low back pain is one of the major causes of disability and thus has a major socioeconomic impact. Intervertebral disc degeneration is the main cause of chronic low back pain. Treatment for chronic discogenic low back pain has traditionally been limited to either conservative management or surgical fusion. If conservative treatment fails, then surgical fusion is commonly considered. Current treatments are limited to treat the symptoms and not the underlying biologic alterations of the disc. Objective: Human umbilical cord tissue-derived mesenchymal stem cells (HUC-MSCs) contain stem cells and possess the ability to regenerate degenerative discs. Based on the results of previous in vitro and animal experiments, we conducted a preliminary study to test the feasibility and safety and to obtain an early indication for the therapeutic value of HUC-MSC transplantation in patients with chronic discogenic low back pain. Study Design: This is the first study involving treatment of chronic low back pain using HUCMSC transplantation. Setting: The study was performed at a spine center in China. Methods: Two patients with chronic discogenic low back pain were treated with HUC-MSC transplantation. An 11-point visual analog scale (VAS, 0 – 10) and Oswestry Disability Index (ODI, 0 – 100) were used to assess the back pain symptoms and the lumbar function, respectively. Results: After transplantation, the pain and function improved immediately in the 2 patients. The VAS and ODI scores decreased obviously during a 2-year follow-up period. Limitations: The shortcoming of this study is that it is a preliminary study with only 2 patients. Conclusion: The clinical outcomes indicated that HUC-MSC transplantation is a favorable alternative method for the treatment of chronic discogenic low back pain. Key words: Intervertebral disc degeneration, discogenic low back pain, chronic low back pain, lumbar discography, mesenchymal stem cells, human umbilical cord mesenchymal stem cells, transplantation
- Research Article
6
- 10.3389/fpain.2023.1092158
- May 5, 2023
- Frontiers in Pain Research
Chronic low back pain is a debilitating condition that impacts millions of individuals around the world, and also has an enormous economic impact. The impact of chronic pain does not only involve physical health, but can also play a detrimental role in a patient's mental health. Consequently, it is critical to approach these patients with multimodal management. Initially, a treatment plan which includes medications, psychotherapy, physical therapy, and invasive interventions can be utilized for chronic back pain. However, many patients experience refractory low back pain to these initial treatments, which can result in non-resolving chronic pain. As a result, many new interventions have been developed in recent years to treat refractory low back pain, including non-invasive transcranial magnetic stimulation. In recent years, there has been some limited and preliminary evidence for the treatment of chronic low back pain with transcranial magnetic stimulation, as further investigation on this intervention is warranted. After reviewing analytically high impact studies, our objective is to provide a narrative review of the treatment of chronic low back pain with repetitive transcranial magnetic stimulation (rTMS). We performed a comprehensive database search on PubMed, Embase, PsychInfo, Web of Science, and CINAHL for literature that pertains to the treatment of chronic low back pain with transcranial magnetic stimulation using these terms: "Chronic Low Back Pain and Transcranial Magnetic Stimulation", "Low Back Pain and Transcranial Magnetic Stimulation", "Chronic Back Pain and Transcranial Magnetic Stimulation", "Chronic Low Back Pain and TMS", "Low Back Pain and TMS", and "Chronic Back Pain and TMS". We aim to provide a narrative review of the role of rTMS in CLBP. Initial search results from September to November 2021 using the above-mentioned search criteria included 458 articles, of which 164 duplicates were removed and 280 were further excluded by a three-person (CO, NM and RA) screening process. Articles were further filtered based on various exclusion and inclusion criteria. The resulting 6 studies are discussed. The studies reviewed suggest the potential benefit in chronic lower back pain symptoms after various rTMS protocols and sites of stimulation. However, the included studies are not without issues in design for example: not randomized, not blinded, or have small sample size. This review highlights the need for scaled, better controlled research studies and standardization of treatment protocols to determine if rTMS for chronic lower back pain will be accepted as a standard treatment option for patients with chronic lower back pain symptoms.
- Research Article
- 10.1590/0103-5150.028.001.ao12
- Mar 1, 2015
- Fisioterapia em Movimento
Introduction Chronic low back pain is conceived of as a multifactorial syndrome that results in the loss of functional capacity. It affects the quality of life of an individual and its treatment requires a comprehensive therapeutic approach. Objective The aim of this study is to assess the efficacy of the Santhiflex™ Method in the treatment of chronic low back pain, as well as its effects on functional capacity, health-related quality of life and body posture. Materials and methods 20 patients with chronic low back pain were randomly distributed into two groups of 10: an experimental group, which was treated with the Santhiflex™ Method of psychomotor postural re-education; and a control group, which was given a lecture on postural orientation after the first evaluation. Results The obtained data were analyzed using standard statistical software, SPSS-17 for Windows (SPSS, Chicago, IL, USA) and the results were expressed as absolute and relative frequencies, and median with first and third quartiles. The nonparametric Wilcoxon test was used for within-group samples. Intergroup comparison was performed using the Mann-Whitney test. A value of p < 0.05 was considered statistically significant. There were significant differences in the main factors assessed. Discussion The findings demonstrated a significant total improvement in low back pain scores in the EG, whereas there was no significant change in the CG. Conclusion The Santhiflex™ Method is effective in the treatment of low back pain and has positive effects on functional capacity and health-related quality of life.
- Research Article
46
- 10.1007/s11916-019-0763-3
- Mar 14, 2019
- Current Pain and Headache Reports
The purpose of the present investigation is to summarize supporting evidence for novel sub-perception spinal cord stimulation (SCS) therapy over traditional paresthesia inducing low-frequency waveforms for the treatment of chronic pain. The focus of this review is to summarize key studies comparing traditional low-frequency tonic waveforms to modern high frequency and burst stimulation for the treatment of patients with chronic intractable low back pain and/or leg pain. Several recent studies have demonstrated the benefit of novel SCS therapies over traditional low-frequency SCS for the treatment of patients with chronic low back and/or leg pain. SENZA-RTC showed that paresthesia-free high-frequency SCS was superior to low-frequency stimulation for treatment of chronic low back pain with leg pain. The SUNBURST crossover trial recently found that high-frequency burst stimulation was preferred over low-frequency tonic SCS with patients citing better pain relief and a preference for paresthesia-free SCS. The new ongoing EVOLVE workflow retrospective multicenter study uses technology that can deliver both low-dose and high-dose SCS. Further, the wavewriter technology addresses patient variability with its ability to layer sub-perception waveforms and paresthesia inducing low-frequency stimulation tailored to patient needs via an interactive feedback feature. Neuromodulation for the treatment of chronic pain is rapidly evolving with technology at its forefront. Modern SCS systems use novel waveforms, frequencies, and stimulation modes to deliver paresthesia-free pain relief to patients suffering from chronic low back pain and/or leg pain with better results than traditional tonic low-frequency SCS. As the field advances, new studies are needed comparing new waveform and delivery systems to optimize patient selection and treatment response.
- Research Article
96
- 10.1155/2010/252695
- Jan 1, 2010
- Pain Research and Management
To ascertain knowledge gaps in the diagnosis and treatment of acute and chronic low back pain (LBP) in the primary care setting to prepare a scoping survey for identifying knowledge gaps in LBP management among Alberta's primary care practitioners, and to identify potential barriers to implementing a multidisciplinary LBP guideline. English language studies, published from 1996 to 2008, comparing the clinical practice patterns of primary care practitioners with guideline recommendations were identified by systematically searching literature databases, the websites of various health technology assessment agencies and libraries, and the Internet. Data were synthesized qualitatively. The literature search identified 14 relevant studies. Knowledge gaps were reported among various primary care practitioner groups in the assessment of red flags, use of diagnostic imaging, provision of advice regarding sick leave and continuing activity, administration of some medications (muscle relaxants, oral steroids and opioids) and recommendation of particular treatments (acupuncture, physiotherapy, spinal manipulation, traction, ultrasound, transcutaneous electrical nerve stimulation and spinal mobilization). A know-do gap clearly exists among primary care practitioners with respect to the diagnosis and treatment of LBP. The information on know-do gaps will be used to construct a survey tool for unearthing the local knowledge gaps extant among Alberta's primary care practitioners, and to develop a dissemination strategy for a locally produced multidisciplinary LBP guideline, with the aim of ensuring that the know-do gaps inherent within each primary practice discipline are specifically targeted.
- Abstract
- 10.1016/j.spinee.2022.07.020
- Aug 19, 2022
- The Spine Journal
P64. Intradiscal injection of autologous bone marrow aspirate concentrate improves low back pain at one year
- Research Article
12
- 10.1111/pme.12346
- May 1, 2014
- Pain Medicine
Dear Editor, Discogenic pain affects approximately 45% of patients suffering from chronic low back pain, and it is caused by chemical and mechanical changes of the intervertebral disc [1]. Many different minimally invasive techniques have been used for the treatment of this condition, with various results. We report the combination of intradiscal pulsed radiofrequency combined to gelified ethanol application for the treatment of chronic discogenic low back pain. Pulsed radiofrequency mechanism of action has been well discussed [2,3]. Gelified ethanol is an implantable medical device in which an opaque agent in X-rays (the tungsten) was added [4,5]. The implant is administered within the affected intervertebral disc's nucleus pulposus, via a fine needle that is guided into the center of the disc, transdermally, under fluoroscopic guidance [4,5]. To our knowledge, this is the first report of the combination of the two methods via the same radiofrequency needle, for the treatment of chronic discogenic low back pain. The patients enrolled suffered from discogenic low back pain, refractory to conservative treatment and physiotherapy for at least 6 months, and reported concordant pain during provocative discography. Pain scores (numeric rating scale 0–10) and satisfaction rates (visual analogue scale 0–10, where 0: “worst” satisfaction and …