STUDY DESIGN: A group of surgical candidates with chronic low back pain was compared with a random sample of the general population. OBJECTIVES: To compare the sociodemographic, physical, and psychological characteristics of patients enrolled in a randomized trial of fusion surgery for chronic low back pain with those of an age- and gender-matched general population, and to assess whether the results of the current study can be generalized to other groups of subjects with chronic low back pain. SUMMARY OF BACKGROUND DATA: The patients with low back pain in industry, primary care, and rehabilitation clinics are well described, with evidence of increased psychological distress, social disturbance, and occupational dissatisfaction. The characteristics of surgical candidates with chronic low back pain are less well described and not compared with the general population. METHODS: Social, occupational, psychological, and physical data from self-administered questionnaires completed by 294 consecutive surgical candidates with chronic low back pain were compared with the same data from 278 subjects in an age- and gender-matched random sample of the Swedish general population. Data were analyzed with the general population sample divided in two subgroups: subjects with and those without back pain. RESULTS: The surgical candidates with chronic low back pain differed significantly from the control subjects free of back pain by demonstrating more smoking, general morbidity, and depressive symptoms as well as heavier occupation and self-assessed workload. However, they did not differ from the control subjects with back pain in these respects. In a multiple logistic regression analysis, physical disability was the only variable that independently discriminated between all three groups. The groups did not differ in terms of depressive symptoms. Differences were more obvious between the two general population groups than between the two groups with back pain. The rate of major depression was lower (9%) among the surgical candidates than in other reported groups with chronic low back pain. CONCLUSIONS: The surgical candidates in the current study resembled the average Swedish citizen with back pain. Although selected for treatment because of symptom severity, they did not otherwise differ substantially from the general population with back pain. On the contrary they unexpectedly were affected only a little by depressive symptoms, distinguishing them from patients with chronic low back pain in pain clinics and rehabilitation centers. Therefore, the results of the this outcome study are not generally applicable to every patient with chronic low back pain.
Comment In: Spine. 2002 Jun 1;27(11):1230-112045522
STUDY DESIGN: A multicenter randomized study with a 2-year follow-up period and an independent observer was conducted. OBJECTIVE: To compare three commonly used surgical techniques to achieve lumbar fusion primarily in terms of their ability to reduce pain and decrease disability in patients with severe chronic low back pain. SUMMARY OF BACKGROUND DATA: Lumbar fusion can be used to reduce pain and decrease disability in patients with chronic low back pain, and different surgical techniques are available. The reported results after fusion surgery vary considerably, but most studies are retrospective and/or performed on heterogeneous patient groups. Spine surgeons commonly use the techniques presented in this report. However, in the absence of randomized trials it is difficult to know whether any one of them is better than the others for these patients. METHODS: From 1992 through 1998, 294 patients referred to 19 spinal centers were blindly randomized into four treatment groups: three surgical groups (n = 222) and one nonsurgical group (n = 72). The sociodemographic and clinical characteristics did not differ among the groups. Eligibility included patients 25 to 65 years of age with therapy-resistant chronic low back pain that had persisted for at least 2 years and radiologic evidence of disc degeneration (spondylosis) at L4-L5, L5-S1, or both. Only patients randomized to one of three surgical groups were analyzed in the current study: Group 1 (posterolateral fusion; n = 73), Group 2 (posterolateral fusion combined with variable screw placement, an internal fixation device; n = 74), and Group 3 (posterolateral fusion combined with variable screw placement and interbody fusion; n = 75). The "circumferential fusion" in Group 3 was performed either as an anterior lumbar interbody fusion (n = 56) or as a biomechanically similar posterior lumbar interbody fusion (n = 19). The groups were composed of 51%, 58%, and 40% men respectively, and the respective mean ages were 44, 43, and 42 years. The patients had experienced low back pain for at least 2 years (mean, approximately 8 years). They had been on sick leave for approximately 3 years. Pain was measured by a visual analog scale, and disability was assessed by the Oswestry Low Back Pain Questionnaire, the Million Visual Analogue Score, and the General Function Score. Depressive symptoms were measured by the Zung Depression Scale. The global overall rating of the result was assessed by the patient and an independent observer after 2 years. Hospitalization data including operation time, blood loss, blood transfusion, and days of hospitalization in connection with surgery were reported, along with complications and the fusion rate. Records from the Swedish Social Insurance Board providing information on sick leave and economic compensation for Swedish residents were used to evaluate the patients' work status. RESULTS: An independent observer examined 201 (91%) of 222 patients after 2 years, after 18 "group changers" and 3 dropouts had been excluded from the analyses. All surgical techniques were found to reduce pain and decrease disability substantially, but no significant differences were found among the groups. In all three groups, the patients rated the overall outcome similarly, as did the independent observer. The more demanding techniques in Groups 2 and 3 consumed significantly more resources in terms of operation time, blood transfusions, and days in hospital after surgery. The early complication rate was 6% in Group 1, 16% in Group 2, and 31% in Group 3. The fusion rate, as evaluated by plain radiograph, was 72% in Group 1, 87% in Group 2, and 91% in Group 3. CONCLUSIONS: All the fusion techniques used in the study could reduce pain and improve function in this selected group of patients with severe chronic low back pain. There was no obvious disadvantage in using the least demanding surgical technique of posterolateral fusion without internal fixation.
Cost-effectiveness of lumbar fusion and nonsurgical treatment for chronic low back pain in the Swedish Lumbar Spine Study: a multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group.
A cost-effectiveness study was performed from the societal and health care perspectives.
To evaluate the costs-effectiveness of lumbar fusion for chronic low back pain (CLBP) during a 2-year follow-up.
A full economic evaluation comparing costs related to treatment effects in patients with CLBP is lacking.
A total of 284 of 294 patients with CLBP for at least 2 years were randomized to either lumbar fusion or a nonsurgical control group. Costs for the health care sector (direct costs), and costs associated with production losses (indirect costs) were calculated. Societal total costs were identified as the sum of direct and indirect costs. Treatment effects were measured using patient global assessment of improvement, back pain (VAS), functional disability (Owestry), and return to work.
The societal total cost per patient (standard deviations) in the surgical group was significantly higher than in the nonsurgical group: Swedish kroner (SEK) 704,000 (254,000) vs. SEK 636,000 (208,000). The cost per patient for the health care sector was significantly higher for the surgical group, SEK 123,000 (60,100) vs. 65,200 (38,400) for the control group. All treatment effects were significantly better after surgery. The incremental cost-effectiveness ratio (ICER), illustrating the extra cost per extra effect unit gained by using fusion instead of nonsurgical treatment, were for improvement: SEK 2,600 (600-5,900), for back pain: SEK 5,200 (1,100-11,500), for Oswestry: SEK 11,300 (1,200-48,000), and for return to work: SEK 4,100 (100-21,400).
For both the society and the health care sectors, the 2-year costs for lumbar fusion was significantly higher compared with nonsurgical treatment but all treatment effects were significantly in favor of surgery. The probability of lumbar fusion being cost-effective increased with the value put on extra effect units gained by using surgery.
The Quality of Life Scale (QOLS), developed originally by John Flanagan in the 1970's, has been adapted for use in chronic illness groups. Evidence for reliability and validity has been published over the years for both English and translations. This paper presents further evidence of construct validity for persons with chronic conditions as well as across two languages, and gender.
A sample of 1241 chronically ill and healthy adults from American and Swedish databases was used to generate factor analyses for both the 15-item original QOLS and the 16-item chronic illness adaptation.
Analysis of the data suggested that the QOLS has three factors in the healthy sample and across chronic conditions, two languages and gender. Factors that could be labeled (1) Relationships and Material Well-Being, (2) Health and Functioning, and (3) Personal, Social and Community Commitment were identified.
The QOLS is a valid instrument for measuring domains of quality of life across diverse patient groups.
Current literature suggests that in the long-term, fusion of the lumbar spine in chronic low back pain (CLBP) does not result in an outcome clearly better than structured conservative treatment modes.
This study aimed to assess the long-term outcome of lumbar fusion in CLBP, and also to assess methodological problems in long-term randomized controlled trials (RCTs).
A prospective randomized study was carried out.
A total of 294 patients (144 women and 150 men) with CLBP of at least 2 years' duration were randomized to lumbar fusion or non-specific physiotherapy. The mean follow-up time was 12.8 years (range 9-22). The follow up rate was 85%; exclusion of deceased patients resulted in a follow-up rate of 92%.
Global Assessment (GA) of back pain, Oswestry Disability Index (ODI), visual analogue scale (VAS) for back and leg pain, Zung depression scale were determined. Work status, pain medication, and pain frequency were also documented.
Standardized outcome questionnaires were obtained before treatment and at long-term follow-up. To optimize control for group changers, four models of data analysis were used according to (1) intention to treat (ITT), (2) "as treated" (AT), (3) per protocol (PP), and (4) if the conservative group automatically classify group changers as unchanged or worse in GA (GCAC). The initial study was sponsored by Acromed (US$50,000-US$100,000).
Except for the ITT model, the GA, the primary outcome measure, was significantly better for fusion. The proportion of patients much better or better in the fusion group was 66%, 65%, and 65% in the AT, PP, and GCAC models, respectively. In the conservative group, the same proportions were 31%, 37%, and 22%, respectively. However, the ODI, VAS back pain, work status, pain medication, and pain frequency were similar between the two groups.
One can conclude that from the patient's perspective, reflected by the GA, lumbar fusion surgery is a valid treatment option in CLBP. On the other hand, secondary outcome measures such as ODI and work status, best analyzed by the PP model, indicated that substantial disability remained at long-term after fusion as well as after conservative treatment. The lack of objective outcome measures in CLBP and the cross-over problem transforms an RCT to an observational study, that is, Level 2 evidence. The discrepancy between the primary and secondary outcome measures prevents a strong conclusion on whether to recommend fusion in non-specific low back pain.
Comment In: Spine J. 2016 May;16(5):588-9027261844
Today there is growing awareness among spine surgeons of the advantages in using registers to facilitate the analyses and reporting of treatment outcome. The Swedish Spine register is among the first to be used on a national scale and annual reports are published in international journals. In this paper we discuss our experiences and lessons learned from a paper-based version in 1993, to an online web-based solution in 2005. We emphasise the advantages of registers being owned by the national spine society, a support function available during working hours, online feedback to participating departments and professional assistance in designing a register program for web use. Hopefully, our experiences will be of help to colleagues who are planning to start registering.
*Quantify Research, Stockholm, Sweden †LIME/MMC, Karolinska Institutet, Stockholm, Sweden ‡Futurum-Academy for Health and Care Ryhov Jönköping and Capio St Göran Hospital, Stockholm, Sweden §Spine Center Göteborg, Gothenburg, Sweden.
Spine (Phila Pa 1976). 2017 Sep 01; 42(17):1302-1310
Analysis of Swedish national and regional register data.
The aim of this study was to characterize healthcare resource utilization, productivity loss, and costs of patients with low back pain (LBP) with or without leg pain, who have been referred from primary care settings to orthopedic specialist care.
Register data on outpatient and inpatient care, work absence, drug prescriptions, socioeconomics, and mortality were extracted for patients visiting orthopedic specialists for LBP in the Swedish region Västra Götaland (1.6 million inhabitants in 2015) in 2008 to 2011 (4 years).
Patients were followed with regard to resource use and costs during "LBP episodes," defined as the time period from the first visit to an orthopedic specialist ("index-point") until the last observed resource use registered with an LBP diagnosis. Patients were also followed during fixed time periods of 2 years before and 2 years after the index-point.
In total, 16,329 LBP episodes were identified (13,931 unique patients), in six diagnosis groups. Mean societal cost per LBP episode was estimated at &OV0556;6466 (SD 21,884), where indirect cost constituted 74% and half of the 26% remaining direct costs were owing to hospital inpatient care. Patients underwent surgery in 10% of the episodes (n?=?1583). Cost per LBP episode varied between diagnosis groups, with a range of &OV0556;18,668 to &OV0556;40,774 in episodes with surgery and &OV0556;978 to &OV0556;10,379 in episodes without surgery. Assessment of the fixed time period of 2 years before and after index-point showed that costs increased gradually during the year before in all groups and declined the year after in all groups.
The marked decline in total costs the year after referral to an orthopaedic specialist indicates that the treatment provided, regardless of treatment, has an effect and also likely improves the quality of life for the patient.
Re: Brox JI, Sörensen R, Friis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine. 2003; 28:1913-1921.
Lumbar disc herniation (LDH) is a common indication for lumbar spine surgery. The proportion of patients having a second surgery within 2?years varies in the literature between 0.5% and 24%, with recurrent herniation being the most common cause. Several studies have not found any relevant outcome differences between patients undergoing surgery for primary LDH and patients undergoing reoperation for a recurrent LDH, but these studies have limitations, including small sample size and retrospective design.
We (1) compared patient-reported outcomes between patients operated on for primary LDH and patients reoperated on for recurrent LDH within 1?year after index surgery and (2) determined risk factors for worse outcomes.
We obtained data from the Swedish National Spine Register, Swespine, where patient-reported outcomes are collected using mailed protocols at 1, 2, 5, and 10?years after surgery. Of the 13,562 patients identified who underwent LDH between January 2000 and May 2011, 13,305 (98%) underwent primary surgery for LDH and 257 (2%) underwent reoperation for a recurrent LDH within the first year. Patient-reported outcomes at 1 to 2?years were available for 8497 patients (63%), 8350 of 13,305 (63%) in the primary LDH group and 147 of 257 (57%) in the recurrent LDH group (p?=?0.068). We compared leg and back pain (VAS: 0-100), function (Oswestry Disability Index [ODI]: 0-100), quality of life (EQ-5D: -0.59 to 1.0), patient satisfaction, and global assessment of leg pain between groups. We also analyzed rsik factors for worse global assessment and satisfaction.
Mean (95% CI) differences in improvement between groups favoring patients with primary LDH were VAS leg pain 9 (4-14), ODI 6 (3-9), and EQ-5D 0.09 (0.04-0.15). While statistically significant, these effect sizes may be lower than the minimal clinically important differences often referred to. Percentage of satisfied patients was 79% and 58% in the primary and recurrent LDH groups, respectively (p?
Swespine, the Swedish National Spine Register, has existed for 20 years and is in general use within the country since over 10 years regarding degenerative lumbar spine disorders. Today there are protocols for registering all disorders of the entire spinal column.
Patient-based pre- and postoperative questionnaires, completed before surgery and at 1, 2, 5 and 10 years postoperatively. Among patient-based data are VAS pain, ODI, SF-36 and EQ-5D. Postoperatively evaluation of leg and back pain as compared to preoperatively ("global assessment"), overall satisfaction with outcome and working conditions are registered in addition to the same parameters as preoperatively evaluation. A yearly report is produced including an analytic part of a certain topic, in this issue disc prosthesis surgery. More than 75,000 surgically treated patients are registered to date with an increasing number yearly. The present report includes 7,285 patients; 1-, 2- and 5-year follow-up data of previously operated patients are also included for lumbar disorders as well as for disc prosthesis surgery.
For the degenerative lumbar spine disorders (disc herniation, spinal stenosis, spondylolisthesis and DDD) significant improvements are seen in all aspects as exemplified by pronounced improvement regarding EQ-5D and ODI. Results seem to be stable over time. Spinal stenosis is the most common indication for spine surgery. Disc prosthesis surgery yields results on a par with fusion surgery in disc degenerative pain. The utility of spine surgery is well documented by the results.
Results of spine surgery as documented on a national basis can be utilized for quality assurance and quality improvement as well as for research purposes, documenting changes over time and bench marking when introducing new surgical techniques. A basis for international comparisons is also laid.
Cites: Acta Orthop. 2013 Feb;84(1):7-1123368746
Cites: Spine (Phila Pa 1976). 2013 Mar 1;38(5):435-4122941097