A prospective,randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain

BACKGROUND CONTEXTCurrent literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN).PURPOSEThe purpose of this RCT was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology.STUDY DESIGN/SETTINGA prospective, parallel, open label RCT was conducted at 20 U.S. sites.PATIENT SAMPLEA total of 140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care.OUTCOME MEASURESOswestry Disability Index (ODI) was collected at baseline, 3, 6, 9, and 12-months postprocedure. Secondary outcome measures included a 10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment.METHODSPatients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their 3-month primary endpoint visit.RESULTSThe interim analysis showed clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm. This resulted in a data management committee recommendation to halt enrollment in the study and offer early cross-over to the control arm. These results are comprised of the outcomes of the 104 patients included in the intent-to-treat analysis of the 3-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm. Baseline ODI was 46.1, VAS was 6.67, and mean age was 50 years. The percentage of patients with LBP symptoms ≥5 years was 67.3%. Comparing the RF ablation arm to the standard care arm, the mean changes in ODI at 3 months were −25.3 points versus −4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<.001). Mean changes in VAS were −3.46 versus −1.02, respectively, an adjusted difference of 2.44 cm (p<.001). In the RF ablation arm, 74.5% of patients achieved a ≥10-point improvement in ODI, compared with 32.7% in the standard care arm (p<0.001).CONCLUSIONSMinimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.     

A prospective, randomized 5-year follow-up study of functional restoration in chronic low back pain patients

A functional restoration (FR) program, dealing with a combination of intensive physical and ergonomic training, psychological pain management, and patient education, was tested in two randomized, parallel group studies. In one of these patients following the FR program were compared with a non-treated control group (project A), and in the other with patients on two less intensive treatment programs (project B). A total of 238 chronic low back pain patients participated in the two studies, 106 entering project A and 132 project B. Patients from the two projects were comparable except that the patients in project A were recruited from all over the country, whereas patients in project B all were living in and around Copenhagen. Thirteen patients never started any treatment, and 20 patients (9%) dropped out during the treatment period. Of the 207 who completed treatment, 89% returned a mailed questionnaire 5 years later. This was the case for 55% of the drop-outs. The questions referred to work situation, pain level, activities of daily living, days of sick leave, contact with health care professionals, physical activity, use of medication, and a subjective overall assessment. The results show that in project A the treated group reported significantly fewer contacts with the health care system and significantly fewer days of sick leave over the 5-year follow-up period compared to the control group. In all other parameters, including work ability, there was no statistically significant difference between the two groups. In project B, patients treated in the FR program did significantly better in most measured parameters, except in leg pain, use of pain medication and sport activity, where no significant differences were found between groups. The overall result shows a positive long-term effect of the FR program, but it also shows the necessity of testing a given treatment in different projects and designs, among other things due to statistical variations. Received: 7 May 1997 Revised: 20 October 1997 Accepted: 5 November 1997     

Ablation of the basivertebral nerve for treatment of back pain: a clinical study

Background Content

Lumbar axial back pain arising from degenerative disc disease continues to be a challenging clinical problem whether treated with nonsurgical management, local injection, or motion segment stabilization and fusion.

Acupuncture for chronic low back pain: protocol for a multicenter,randomized, sham-controlled trial

Background  

Use of acupuncture has widely increased in patients with chronic low back pain. However, the evidence supporting its efficacy remains unclear. In this article, we report the design and the protocol of a multi-center randomized sham-controlled trial to treat chronic low back pain. Our goal is to verify the effect of acupuncture on chronic low back pain.     

Active treatment programs for patients with chronic low back pain: a prospective,randomized, observer-blinded study

Summary Several new studies have indicated that an active approach to patients with chronic disabling low back pain (LBP) seems effective. Some of these studies emphasize the importance of dealing with the patient's total situation in comprehensive multidisciplinary programs — the bio-psycho-social model. However, these programs are expensive. The aim of this study was to evaluate the rehabilitation outcome from three different active programs in terms of: (1) return-to-work rate, (2) days of sick leave, (3) health-care contacts, (4) pain and disability scores, and (5) staying physically active. The subjects included 132 patients randomized to the study, of whom 123 started one of the treatment programs. They had all had at least 6 months of chronic LBP. The patients were randomized into one of three programs: group 1 — a full-time, intensive 3-week multidisciplinary program, including active physical and ergonomic training and psychological pain management, followed by 1 day weekly for the subsequent 3 weeks; group 2 — active physical training, twice a week for 6 weeks, for a total of 24h; group 3 — psychological pain management combined with active physical training, twice a week for 6 weeks, also for a total of 24h. The results presented here are based on data collected 4 months following treatment, which shows an 86% response rate. The initial examination and the follow-up evaluation were performed by a blinded observer. The results show that 4 months after treatment, the intensive multidisciplinary program is superior to the less intensive programs in terms of return-to-work rate, health-care contacts, pain and disability scores, and staying physically active. In conclusion, it seems that although the multidisciplinary program is initially expensive compared to the less intensive programs, the savings in sick pay, early retirement pensions, and health care contacts make it economically worthwhile. Long-term follow-up will show whether this effect continues.     

Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcome study with minimum 1-year follow-up

STUDY DESIGN: Prospective case series. OBJECTIVE: To determine the outcome of patients with chronic low back pain whose symptoms did not improve with aggressive nonoperative care and who chose (intradiscal electrothermal anuloplasty) IDET as an alternative to chronic pain management or interbody fusion surgery. SUMMARY OF BACKGROUND DATA: Patients with unremitting chronic discogenic low back pain are faced with the choice of long-term pain management or fusion surgery. Intradiscal electrothermal anuloplasty (IDET) was developed as an alternative minimally invasive treatment. MATERIALS AND METHODS: Sixty-two patients from the author's practice who had chronic low back pain unresponsive to nonoperative care, no evidence of compressive radiculopathy, and concordant pain reproduction at one or more disc levels on provocative discography were enrolled in the study. Visual analog scale (VAS) pain scores and Short Form (SF)-36 Health Status Questionnaire Physical Function subscale and SF-36 Bodily Pain subscale scores were assessed at baseline and at least 1 year later. RESULTS: Mean follow-up was 16 months, and mean preoperative duration of symptoms was 60 months. Baseline and follow-up outcome measures demonstrated a mean change in VAS score of 3.0 (P < 0.001), mean change in SF-36 physical function of 20 (P < 0.001), and mean change in SF-36 bodily pain of 17 (P < 0.001). Symptoms improved in 44 (71%) of 62 of the study group on the SF-36 physical function subscale, in 46 (74%) of 62 on the SF-36 Bodily Pain subscale, and in 44 (71%) of 62 on the VAS scores. Twelve (19%) of 62 of the patients did not show improvement on any scale. CONCLUSION: A cohort of patients with chronic unremitting low back pain of discogenic origin whose symptoms had failed to improve with aggressive nonoperative care demonstrated a statistically significant and clinically meaningful improvement on the SF-36 and the VAS scores at a minimum follow-up of 1 year after IDET. The positive results should be validated with placebo-controlled randomized trials and studies that compare IDET with alternative treatments.-     

Radiotherapy for pain in chronic, degenerative low back pain syndrome--results of a prospective randomized study

AIM OF STUDY: A low-dose radiotherapy with 5 Gy on the lumbar spine in patients with chronic low back pain was investigated. METHOD: 31 patients with non-radicular low back pain since three years at the age of at least 50 years (64.3 years on average) were treated. A psychosomatic etiology of pain was excluded. 5 Gy or 0.5 Gy (placebo dose) were applied in five fractions to the lumbar spine including the facet joints. The pain was evaluated by means of the Oswestry-Disability-Score before, six weeks after therapy, and every three months during the follow-up (22.4 months on average). Drug therapy, physiotherapy, and physical treatment were continued. RESULTS: According to the randomised distribution, 18 patients were treated with 5 Gy and 13 patients with 0.5 Gy. The Friedman-Test did not reveal any significant difference (p > 0.05) of the Oswestry-Disability-Index before and after therapy for both single questions and the sum of questions in both groups. CONCLUSION: No significant decrease of the Disability Index after radiotherapy on the lumbar spine with 5 Gy could be demonstrated in the verum and placebo group. The authors do not recommend radiotherapy in cases of chronic low back pain. Individual successes have to be attributed to conservative treatment or placebo effects.     

Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study

We conducted a double-blind randomized placebo-controlled study to investigate the effects of short-term 890-nm light therapy in patients with chronic low back pain in a rehabilitation clinic. Thirty-eight women and 22 men with chronic low back pain (mean age, 60.3 years; range, 32–80 years) received 40-min sessions of hot-pack therapy combined with active or placebo 890-nm light therapy (wavelength?=?890 nm, radiant power output?=?6.24 W, power density?=?34.7 mW/cm² for 40 min, total energy?=?83.2 J/cm²) over the lower back three times weekly for 2 weeks. Participants were assessed before and after treatment by using a range of motion measurements, a visual analog scale evaluation of pain, the Multidimensional Fatigue Inventory, the Biodex Stability System, the Fear-Avoidance Beliefs Questionnaire, repeated chair-rising times, the Frenchay Activity Index, the Oswestry Disability Questionnaire (ODQ), and the Osteoarthritis Quality of Life Questionnaire. The severity of disability based on the ODQ score was used as the primary clinical outcome measurement. Compared to the baseline measurements, participants in the treatment group reported significant reductions in fear-avoidance beliefs regarding physical activity (P?=?0.040) and work (P?=?0.007) and in the severity of disability (P?=?0.021). Treatment with hot-pack therapy and 890-nm light therapy was associated with reductions in the severity of disability and fear avoidance beliefs in patients with chronic low back pain.     

Exercise as a treatment for chronic low back pain.

BACKGROUND CONTEXT: Exercise is a widely prescribed treatment for chronic low back pain, with demonstrated effectiveness for improving function and work. PURPOSE: The goal of this article is to review several key aspects about the safety and efficacy of exercise that may help clinicians understand its utility in treating chronic back pain. STUDY DESIGN/SETTING: A computerized literature search of MEDLINE was conducted using "exercise," "fitness," "back pain," "backache" and "rehabilitation" as search words. Identified abstracts were scanned, and useful articles were acquired for further review. Additional references were acquired through the personal collections of research papers possessed by the authors and by reviewing prior review articles on this subject. These final papers were scrutinized for data relevant to the key aspects about exercise covered in this article. RESULTS: For people with acute, subacute or chronic low back pain, there is no evidence that exercise increases the risk of additional back problems or work disability. To the contrary, current medical literature suggests that exercise has either a neutral effect or may slightly reduce risk of future back injuries. Exercise can be prescribed for patients with chronic low back pain with three distinct goals. The first and most obvious goal is to improve or eliminate impairments in back flexibility and strength, and improve performance of endurance activities. There is a large body of evidence confirming that this goal can be accomplished for a majority of patients with chronic low back pain. The second goal of exercise is to reduce the intensity of back pain. Most studies of exercise have noted overall reduction in back pain intensity that ranges from 10% to 50% after exercise treatment. The third goal of exercise is to reduce back pain-related disability through a process of desensitization of fears and concerns, altering pain attitudes and beliefs and improving affect. The mechanisms through which exercise can accomplish this goal have been the subject of substantial research. CONCLUSIONS: Exercise is safe for individuals with back pain, because it does not increase the risk of future back injuries or work absence. Substantial evidence exists supporting the use of exercise as a therapeutic tool to improve impairments in back flexibility and strength. Most studies have observed improvements in global pain ratings after exercise programs, and many have observed that exercise can lessen the behavioral, cognitive, affect and disability aspects of back pain syndromes.     

Efficacy of a functional restoration program for chronic low back pain: Prospective 1-year study

ObjectiveTo evaluate the efficacy of a functional restoration program for patients with chronic low back pain, using overall disability and work ability as the primary evaluation criteria.Patients and methodsWe prospectively studied patients aged 18 years or older who had been on sick leave because of nonspecific low back pain for at least 3 months and whose job position was still open. The program was delivered on a day-hospital basis 5 days a week for 5 weeks. Patients were followed up for 1 year.ResultsWe included 39 patients, 11 females and 28 males with a mean (± SD) age of 43 ± 8 years and a mean sick-leave duration of 10 ± 7 months. After 1 year, 26 (67%) patients reported improvements and 25 (64%) had returned to work. Compared to the year before the program, the number of sick leave days was decreased by 51% (120 ± 140 vs. 244 ± 114, P < 0.05). The work-and-leisure-activities subscore of the validated French version of the Dallas Pain Questionnaire (DRAD) was significantly improved (57 ± 24 vs. 70 ± 17 at baseline, P < 0.05). The patients still on sick leave after 1 year were older and had greater alterations in baseline DRAD subscores for anxiety/depression and daily activities, compared to the patients who had returned to work.ConclusionsOur functional restoration program was effective and allowed two-thirds of patients to resume work. Factors associated with failure to resume work were well-known correlates of chronicity. Our results support the use of functional restoration programs in patients with incapacitating low back pain. They suggest that functional restoration may deserve to be started earlier, after only 3 months with chronic pain, in patients who are unable to work.