Sexual function in men and women after anterior surgery for chronic low back pain.

Sexual dysfunction after anterior lumbar fusion has mainly been focused on male biological function (retrograde ejaculation). The aim of the present study is to assess the effect of fusion surgery for chronic low back pain on the sex-related quality of life. Apart from routine prospective questionnaires, additional gender-specific mailed questionnaires produced retrospective data on sexual enjoyment and function after 2 years of follow-up. Patients randomised to non-surgical treatment and anterior or posterior fusion were compared. We found that surgically treated patients had a significantly better sex life than those non-surgically treated. The improved sex life was significantly associated with the reduced back pain. The improvement after anterior fusion, however, was counteracted by a trend towards disturbed orgasm and genital sensation in women, and a significant disturbance of ejaculation and genital sensation in men. In view of the increased frequency of anterior lumbar surgery with the strong promotion of disc replacement, the findings in the present small retrospective pilot study should be tested in larger prospective trials.

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.

STUDY DESIGN: A cost-effectiveness study was performed from the societal and health care perspectives. OBJECTIVE: To evaluate the costs-effectiveness of lumbar fusion for chronic low back pain (CLBP) during a 2-year follow-up. SUMMARY OF BACKGROUND DATA: A full economic evaluation comparing costs related to treatment effects in patients with CLBP is lacking. PATIENTS AND METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Complications in lumbar fusion surgery for chronic low back pain: comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group.

The reported complication rates after various surgical techniques used to create a lumbar fusion vary within wide ranges. In a previous paper, the Swedish Lumbar Spine Study Group have reported on the clinical outcome of lumbar spine fusion for chronic low back pain in a comparably homogeneous patient population where there were no significant differences between baseline sociodemographic, clinical and paraclinical characteristics. In this report we compared the complication rates of the surgical procedures used in that study and analyzed the association between complications and baseline variables, and between outcome results and complications. A multicenter randomized study was conducted where 211 patients aged 25-65 were treated with lumbar fusion according to three different surgical techniques: noninstrumented posterolateral fusion (PLF, n=71), instrumented posterolateral fusion (VSP, n=68), and in the third procedure we added an interbody fusion with solid autogenous bone grafts ("360", n=72). We categorized complications as: early/late, major/minor. The association between complications and sociodemographic characteristics (age, gender, comorbidity, previous surgery, smoking), and technical variables (surgical technique, levels fused, hospital category) was analyzed. The association between outcome variables (patient global assessment, pain, disability, depressive symptoms) and complications was analyzed. A literature review was conducted. There was no mortality. There was no significant difference in clinical outcome between the surgical groups after 2 years, although the power to detect such a difference was low. The total complication rate after 2 years in the PLF group was 12%, compared with 22% in the VSP group, and 40% in the "360" group (P=0.0003). After exclusion of complications, there was still no difference in outcome between the groups. The odds ratio (confidence intervals) of having a complication was 5.3 (2.2-12.7) when "360" was used compared with PLF, and 2.4 (1.1-5.3) for "360" compared with VSP. There was no association between clinical outcome and complications on a group level. The reintervention rate was 6% in the PLF group, 22% in the VSP, and 17% in the "360" group (P=0.020). The odds ratio (confidence intervals) of having a reintervention was 4.0 (1.3-11.9) when instrumentation was used compared with non-instrumented fusion. In this prospective randomized study comparing three lumbar fusion techniques in a comparably homogeneous patient population, complications increased significantly with increasing technicality of the surgical procedure. Even though we did not find a significant association between clinical outcome and complications after 2 years, the increased morbidity inflicted on an individual patient was not negligible. In this light, and as no fusion technique produced superior clinical outcome irrespective of whether complications were included or excluded in the analyses, the patient and the treating physician should carefully discuss the possible advantages and drawbacks of the different surgical options before making a decision. In order to make valid comparisons of both complication and reintervention rates after lumbar fusion, there is a need for a consensus in the spinal society regarding the definition of these entities.

Chronic low back pain and fusion: a comparison of three surgical techniques: a prospective multicenter randomized study from the Swedish lumbar spine study group.

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.

Simplifying outcome measurement: evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain.

STUDY DESIGN: A comparative evaluation of outcome instruments and global assessment was performed. OBJECTIVE: To test patient global assessment as a substitute for the use of more comprehensive outcome instruments in treatment trials of chronic low back pain. SUMMARY OF BACKGROUND DATA: Treatment outcome can be measured with pain scales and functional instruments. In the absence of a gold standard, the patient him- or herself is the basic reference for outcome, for which the instruments give a more or less exact measurement. Global assessment, which is a retrospective recording, may overestimate improvement as a result of recall or motivational bias. METHODS: In this study, 294 patients treated for chronic low back pain were evaluated with a visual analog scale for back pain, the Oswestry Disability Index, the Million Score and general function score for disease-specific disability, and the Zung Depression Scale for depressive symptoms. The correlation between the pretreatment and posttreatment scores for the outcome instruments (Delta scores) and the global assessment scores was calculated; effect sizes were compared; sensitivity and specificity with receiver operating characteristics (ROC) curves were estimated; and associations of global assessment with pretreatment and posttreatment scores were determined. RESULTS: All the Delta scores showed significant correlations with patient global assessment and with each other. The effect size of global assessment tended to be greater than that of the outcome instruments. The specificity and sensitivity of the disability instruments and pain scale were approximately 75%, whereas they were lower for depression. The associations between global assessment and outcome instrument scores did not produce evidence that global assessment was biased. CONCLUSION: Patient global assessment is a valid and responsive descriptor of overall effect in randomized controlled trials of treatment for chronic low back pain.

Characteristics of patients with chronic low back pain selected for surgery: a comparison with the general population reported from the Swedish lumbar spine study.

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.