Case manager-assisted rehabilitation for lumbar spinal fusion patients: an economic evaluation alongside a randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the cost-effectiveness of case manager-assisted rehabilitation as an add-on to usual physical rehabilitation after lumbar spinal fusion, given the lack of any clinical benefits found on analysing the clinical data. DESIGN: Economic evaluation alongside a randomized controlled trial with two-year follow-up. SETTING: Patients from the outpatient clinics of a university hospital and a general hospital. SUBJECTS: A total of 82 lumbar spinal fusion patients. INTERVENTIONS: Patients were randomized one-to-one to case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation. MAIN MEASURES: Oswestry Disability Index and EuroQol 5-dimension. Danish preference weights were used to estimate quality-adjusted life years. Costs were estimated from micro costing and national registries. Multiple imputation was used to handle missing data. Costs and effects were presented with means (95% confidence interval (CI)). The incremental net benefit was estimated for a range of hypothetical values of willingness to pay per gain in effects. RESULTS: No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed. Intervention cost was Euros 3984 (3468; 4499), which was outweighed by average reductions in inpatient resource use and sickness leave. A cost reduction of Euros 1716 (-16,651; 20,084) was found in the case manager group. Overall, the probability for the case manager-assisted rehabilitation programme being cost-effective did not exceed a probability of 56%, regardless of willingness to pay. Sensitivity analysis did not change the conclusion. CONCLUSION: This case manager-assisted rehabilitation programme was unlikely to be cost-effective.

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients.

BACKGROUND: Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF). METHODS: Ninety patients undergoing LSF due to degenerative spinal disorders were randomly allocated to either the CBT group or the control group. Both groups received surgery and postoperative rehabilitation. In addition, the CBT group received a preoperative intervention focussed on pain coping using a CBT approach. Primary outcome was back pain during the first week (0-10 scale). Secondary outcomes were mobility, analgesic consumption, and length of hospitalisation. Data were retrieved using self-report questionnaires, assessments made by physical therapists and from medical records. RESULTS: No difference between the groups' self-reported back pain (p = 0.76) was detected. Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days. Analgesic consumption tended to be lower in the CBT group, whereas length of hospitalisation was unaffected by the CBT intervention. CONCLUSION: Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase, despite equally high levels of self-reported acute postsurgical pain in the two groups, and a slightly lower intake of rescue analgesics in the CBT group. This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention. TRIAL REGISTRATION: The study was approved by the Danish Protection Agency (2011-41-5899) and the Ethics Committee of the Central Denmark Region (M-20110047). The trial was registered in Current Controlled Trials ( ISRCTN42281022 ).

Preoperative Cognitive-Behavioral Patient Education Versus Standard Care for Lumbar Spinal Fusion Patients: Economic Evaluation Alongside a Randomized Controlled Trial.

STUDY DESIGN: A cost-effectiveness analysis conducted alongside a randomized clinical trial. OBJECTIVE: To assess the cost-effectiveness of a preoperative cognitive-behavioral therapy (CBT) intervention compared to usual care for patients undergoing lumbar spinal fusion surgery (LSF). SUMMARY OF BACKGROUND DATA: The clinical effectiveness of a preoperative CBT intervention for patients undergoing LSF has been investigated in a randomized clinical trial. Economic evaluation is however essential for decision makers to make informed choices regarding allocation of scarce resources. METHODS: 90 patients undergoing LSF were randomly allocated to usual care (control group) or usual care plus a preoperative CBT intervention (CBT group). Outcome parameters included quality-adjusted life years (QALY), based on the EQ-5D, and pain-related disability, based on the Oswestry disability index (ODI). Health care use and productivity loss were estimated from national registers. RESULTS: One year after LSF the estimated QALY was significantly better for the CBT group with 0.710 (95% CI 0.670; 0.749) versus 0.636 (95% CI 0.5573; 0.687). For the ODI, the CBT group reported significantly larger disability reductions at 3 months (P = 0.003) and 6 months (P = 0.047), but not at 1 year (P = 0.082). There was no difference in the overall costs of the two groups (-€89 (95% CI -12,080; 11,902)), leading to a 70% probability of the CBT intervention being cost-effective at a willingness-to-pay of €40,000 for one additional QALY. For an additional gain of 15 ODI points the probability was 90% at a threshold of €10,000. These results remained largely unaffected by relevant sensitivity analyses, confirming the robustness of findings. CONCLUSION: Preoperative CBT appears to be more effective and cost neutral when considering the overall health care sector and labor market perspective, supporting the implementation of preoperative CBT in the course of treatment for LSF surgery in a Danish context.

Does a preoperative cognitive-behavioral intervention affect disability, pain behavior, pain, and return to work the first year after lumbar spinal fusion surgery?

STUDY DESIGN: A randomized clinical trial including 90 patients. OBJECTIVE: To examine the effect of a preoperative cognitive-behavioral intervention (CBT) for patients undergoing lumbar spinal fusion (LSF) surgery. SUMMARY OF BACKGROUND DATA: Few published studies have looked at the potential of rehabilitation to improve outcomes after LSF. Rehabilitation programs using CBT are recommended. Furthermore, initiating interventions preoperatively seems beneficial, but only limited data exist in the field of spine surgery. METHODS: Patients with degenerative disc disease or spondylolisthesis undergoing LSF were randomized to usual care (control group) or preoperative CBT and usual care (CBT group). Primary outcome was change in Oswestry Disability Index from baseline to 1-year follow-up. Secondary outcomes were catastrophizing, fear avoidance belief, work status, and back and leg pain. RESULTS: At 1-year follow-up, there was no statistically significant difference between the CBT group and the control group in Oswestry Disability Index score (P = 0.082). However, the CBT group had achieved a significant reduction of -15 points (-26; -4) already at 3 months (between group difference P = 0.003), and this reduction was maintained throughout the year. There were no differences between groups at 1-year follow-up with regard to any of the secondary outcomes. CONCLUSION: Participating in a preoperative CBT intervention in addition to usual care did not produce better outcomes at 1-year follow-up for patients undergoing LSF. Although the reduction in disability was achieved much faster in the CBT group, resulting in a significant difference between groups already 3 months after surgery, it did not translate into a faster return to work. Our findings support the need for further research into the use of targeted rehabilitation interventions among patients with elevated levels of catastrophizing and fear avoidance beliefs. LEVEL OF EVIDENCE: 2.

Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery.

BACKGROUND: The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. METHODS/DESIGN: The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. DISCUSSION: It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42281022.

The Canadian Occupational Performance Measure's semi-structured interview: its applicability to lumbar spinal fusion patients. A prospective randomized clinical study.

BACKGROUND: Although lumbar spinal fusion has been performed for more than 70 years, few studies have examined rehabilitation strategies for spinal fusion patients, and there is only sparse information about the patient's activity level after surgery. The Canadian Occupational Performance Measure (COPM) is a standardized semi-structured interview, developed to identify patients' problems in relation to activities of daily living (ADL). The COPM has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients. We aimed to examine whether or not the use of the semi-structured interview COPM during in-hospital rehabilitation could: (1) identify more ADL-related problems of importance to the patients after discharge from the hospital, (2) enhance the patients' ADL performance after discharge from hospital METHOD: Eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the COPM or to standard treatment. RESULTS AND CONCLUSION: Use of the COPM during hospitalization helped in identifying more ADL problems encountered by patients during the first 3 months post-discharge period as COPM served to identify more treatment goals and plans of action. Use of the COPM had no impact on the patients' ADL performance, and the difference is so small that COPM may be of little clinical consequence.

Interchangeability of the EQ-5D and the SF-6D in long-lasting low back pain.

OBJECTIVES: The objective of this study was to investigate the interchangeability of the EuroQol 5D (EQ-5D) and the Short Form 6D (SF-6D) in individuals with long-lasting low back pain to guide the optimal choice of instrument and to inform decision-makers about any between-measure discrepancy, which require careful interpretation of the results of cost-utility evaluations. METHODS: A cross-sectional study was conducted across 275 individuals who had spinal surgery on indication of chronic low back pain. EQ-5D and SF-6D were mailed to respondents for self-completion. Statistical analysis of between-measure agreement (using English weights) was based on Bland and Altman's limits of agreement and a series of linear regressions. RESULTS: A moderate mean difference of 0.085 (SD 0.241) was found, but because it masked more severe bidirectional variation, the expected variation between observations of EQ-5D and SF-6D in future studies was estimated at 0.546. The EQ-5D's N3 term alone explained a factor of 0.79 of the variation in between-measure differences, while the explanatory value of adding variables of age, sex, diagnosis, previous surgery, and occupational status was basically zero. A final model including only dummy variables for the N3 term and five identified framing effects explained a factor of 0.86 of the variation in between-measure differences. CONCLUSIONS: Although the EQ-5D and the SF-6D are both psychometrically valid for generic outcome assessment in long-lasting low back pain, it appears that they cannot generally be used interchangeably for measurement of preference values. Sensitivity analysis examining the impact of between-measure discrepancy thus remains a necessary condition for the interpretation of the results of cost-utility evaluations.

Microdialysis of paraspinal muscle in healthy volunteers and patients underwent posterior lumbar fusion surgery.

Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study was to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD). The basic interstitial metabolisms of the paraspinal muscle and the deltoid muscle were monitored using the MD technique in eight patients, who underwent posterior lumbar fusion surgery (six male and two female, median age 57.7 years, range 37-74) and eight healthy individuals for different positions (five male and three female, age 24.1 +/- 0.8 years). Concentrations of glucose, glycerol, and lactate pyruvate ratio (L/P) in both tissues were compared. In the healthy group, the glucose and glycerol concentrations and L/P were unchanged in the paraspinal muscle when the body position changed from prone to supine. The glucose concentration and L/P were stable in the paraspinal muscle during the surgery. Glycerol concentrations increased significantly to 243.0 +/- 144.1 microM in the paraspinal muscle and 118.9 +/- 79.8 microM in the deltoid muscle in the surgery group. Mean glycerol concentration difference (GCD) between the paraspinal muscle and the deltoid tissue was 124.1 microM (P = 0.003, with 95% confidence interval 83.4-164.9 microM). The key metabolism of paraspinal muscle can be monitored by MD during the conventional posterior lumbar fusion surgery. The glycerol concentration in the paraspinal muscle is markedly increased compared with the deltoid muscle during the surgery. It is proposed that GCD can be used to evaluate surgery related paraspinal muscle damage. Changing body position did not affect the paraspinal muscle metabolism in the healthy subjects.

Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain.

Although cost-effectiveness is becoming the foremost evaluative criterion within health service management of spine surgery, scientific knowledge about cost-patterns and cost-effectiveness is limited. The aims of this study were (1) to establish an activity-based method for costing at the patient-level, (2) to investigate the correlation between costs and effects, (3) to investigate the influence of selected patient characteristics on cost-effectiveness and, (4) to investigate the incremental cost-effectiveness ratio of (a) posterior instrumentation and (b) intervertebral anterior support in lumbar spinal fusion. We hypothesized a positive correlation between costs and effects, that determinants of effects would also determine cost-effectiveness, and that posterolateral instrumentation and anterior intervertebral support are cost-effective adjuncts in posterolateral lumbar fusion. A cohort of 136 consecutive patients with chronic low back pain, who were surgically treated from January 2001 through January 2003, was followed until 2 years postoperatively. Operations took place at University Hospital of Aarhus and all patients had either (1) non-instrumented posterolateral lumbar spinal fusion, (2) instrumented posterolateral lumbar spinal fusion, or (3) instrumented posterolateral lumbar spinal fusion + anterior intervertebral support. Analysis of costs was performed at the patient-level, from an administrator's perspective, by means of Activity-Based-Costing. Clinical effects were measured by means of the Dallas Pain Questionnaire and the Low Back Pain Rating Scale at baseline and 2 years postoperatively. Regression models were used to reveal determinants for costs and effects. Costs and effects were analyzed as a net-benefit measure to reveal determinants for cost-effectiveness, and finally, adjusted analysis (for non-random allocation of patients) was performed in order to reveal the incremental cost-effectiveness ratios of (a) posterior instrumentation and (b) anterior support. The costs of non-instrumented posterolateral spinal fusion were estimated at DKK 88,285(95% CI 81,369;95,546), instrumented posterolateral spinal fusion at DKK 94,396(95% CI 89,865;99,574) and instrumented posterolateral lumbar spinal fusion + anterior intervertebral support at DKK 120,759(95% CI 111,981;133,738). The net-benefit of the regimens was significantly affected by smoking and functional disability in psychosocial life areas. Multi-level fusion and surgical technique significantly affected the net-benefit as well. Surprisingly, no correlation was found between treatment costs and treatment effects. Incremental analysis suggested that the probability of posterior instrumentation being cost-effective was limited, whereas the probability of anterior intervertebral support being cost-effective escalates as willingness-to-pay per effect unit increases. This study reveals useful and hitherto unknown information both about cost-patterns at the patient-level and determinants of cost-effectiveness. The overall conclusion of the present investigation is a recommendation to focus further on determinants of cost-effectiveness. For example, patient characteristics that are modifiable at a relatively low expense may have greater influence on cost-effectiveness than the surgical technique itself--at least from an administrator's perspective.

Outcome in adolescent idiopathic scoliosis after brace treatment and surgery assessed by means of the Scoliosis Research Society Instrument 24.

A retrospectively designed long-term follow-up study of adolescent idiopathic scoliosis (AIS) patients who had completed treatment, of at least 2 years, by means of brace, surgery, or both brace and surgery. This study is to assess the outcome after treatment for AIS by means of the Scoliosis Research Society Outcome Instrument 24 (SRS 24). One hundred and eighteen AIS patients (99 females and 19 males), treated at the Aarhus University Hospital from January 1, 1987 to December 31, 1997, were investigated with at least 2 years follow-up at the time of receiving a posted self-administered questionnaire. Forty-four patients were treated with Boston brace (B) only, 41 patients had surgery (S), and 33 patients were treated both with brace and surgery (BS). The Cobb angles of the three treatment groups did not differ significantly after completed treatment. The outcome in terms of the total SRS 24 score was not significantly different among the three groups. B patients had a significantly better general (not treatment related) self-image and higher general activity level than the total group of surgically treated patients, while surgically treated patients scored significantly better in post-treatment self-image and satisfaction. Comparing B with BS we found a significantly higher general activity level in B patients, while the BS group had significantly higher satisfaction. There were no significant differences between BS and S patients in any of the domain scores. All treatment groups scored "fair or better" in all domain scores of the SRS 24 questionnaire, except in post-treatment function, where all groups scored worse than "fair". Improvement of appearance by means of surgical correction increases mean scores for post-treatment self-image and post-treatment satisfaction. Double-treatment by brace and surgery does not appear to jeopardize a good final outcome.

Healing properties of allograft from alendronate-treated animal in lumbar spine interbody cage fusion.

This study investigated the healing potential of allograft from bisphosphonate-treated animals in anterior lumbar spine interbody fusion. Three levels of anterior lumbar interbody fusion with Brantigan cages were performed in two groups of five landrace pigs. Empty Brantigan cages or cages filled with either autograft or allograft were located randomly at different levels. The allograft materials for the treatment group were taken from the pigs that had been fed with alendronate, 10 mg daily for 3 months. The histological fusion rate was 2/5 in alendronate-treated allograft and 3/5 in non-treated allograft. The mean bone volume was 39% and 37.2% in alendronate-treated or non-treated allograft (NS), respectively. No statistical difference was found between the same grafted cage comparing two groups. The histological fusion rate was 7/10 in all autograft cage levels and 5/10 in combined allograft cage levels. No fusion was found at all in empty cage levels. With the numbers available, no statistically significant difference was found in histological fusion between autograft and allograft applications. There was a significant difference of mean bone volume between autograft (49.2%) and empty cage (27.5%) (P<0.01). In conclusion, this study did not demonstrate different healing properties of alendronate-treated and non-treated allograft for anterior lumbar interbody fusion in pigs.

Lumbar spinal fusion. Outcome in relation to surgical methods, choice of implant and postoperative rehabilitation.

Chronic low back pain (CLBP) has become one of the most common causes of disability in adults under 45 years of age and is consequently one of the most common reasons for early retirement in industrialised societies. Accordingly, CLBP represents an expensive drain on society's resources and is a very challenging area for which a consensus for rational therapy is yet to be established. The spinal fusion procedure was introduced as a treatment option for CLBP more than 70 years ago. However, few areas of spinal surgery have caused so much controversy as spinal fusion. The literature reveals divergent opinions about when fusion is indicated and how it should be performed. Furthermore, the significance of the role of postoperative rehabilitation following spinal fusion may be underestimated. There exists no consensus on the design of a program specific for rehabilitation. Ideally, for any given surgical procedure, it should be possible to identify not only possible complications relative to a surgical procedure, but also what symptoms may be expected, and what pain behaviour may be expected of a particular patient. The overall aims of the current studies were: 1) to introduce patient-based functional outcome evaluation into spinal fusion treatment; 2) to evaluate radiological assessment of different spinal fusion procedures; 3) to investigate the effect of titanium versus stainless steel pedicle screws on mechanical fixation and bone ingrowth in lumbar spinal fusion; 4) to analyse the clinical and radiological outcome of different lumbar spinal fusion techniques; 5) to evaluate complications and re-operation rates following different surgical procedures; and 6) to analyse the effect of different rehabilitation strategies for lumbar spinal fusion patients. The present thesis comprises 9 studies: 2 clinical retrospective studies, 1 clinical prospective case/reference study, 5 clinical randomised prospective studies and 1 animal study (Mini-pigs). In total, 594 patients were included in the investigation from 1979 to 1999. Each had prior to inclusion at least 2 years of CLBP and had therefore been subjected to most of the conservative treatment leg pain, due to localized isthmic spondylolisthesis grades I-II or primary or secondary degeneration. PATIENT-BASED FUNCTIONAL OUTCOME: Patients' self-reported parameters should include the impact of CLBP on daily activity, work and leisure time activities, anxiety/depression, social interests and intensity of back and leg pain. Between 1993 and 2003 approximately 1400 lumbar spinal fusion patients completed the Dallas Pain Questionnaire under prospective design studies. In 1996, the Low Back Pain Rating scale was added to the standard questionnaire packet distributed among spinal fusion patients. In our experience, these tools are valid instruments for clinical assessment of candidates for spinal fusion procedures. RADIOLOGICAL ASSESSMENT: It is extremely difficult to interpret radiographs of both lumbar posterolateral fusion and anterior interbody fusion. Plain radiographs are clearly not the perfect media for analysis of spinal fusion, but until new and better diagnostic methods are available for clinical use, radiographs will remain the golden standard. Therefore, the development of a detailed reliable radiographic classification system is highly desirable. The classification used in the present thesis for the evaluation of posteroalteral spinal fusion, both with and without instrumentation, demonstrated good interobserver and intraobserver agreement. The classification showed acceptable reliability and may be one way to improve interstudy and intrastudy correlation of radiologic outcomes after posterolateral spinal fusion. Radiology-based evaluation of anterior lumbar interbody fusion is further complicated when cages are employed. The use of different cage designs and materials makes it almost impossible to establish a standard radiological classification system for anterior fusions. BONE-SCREW INTERFACE: Mechanical binding at the bone-screw interface was significantly greater for titanium pedicle screws than it was for stainless steel. This could be explained by the fact that the titanium screws had superior bone on-growth. There was no correlation between screw removal torques and pull-out strength. Clinically, the use of titanium and titanium-alloy pedicle screws may be preferable for osteoporotic patients and those with decreased osteogenesis. OUTCOME: The present series of studies observed significant long-term functional improvement for approximately 70% of patients who had undergone lumbar spinal fusion procedure. Solid fusion as determined from radiographs ranged from 52% to 92% depending on the choice of surgical procedure. The choice of surgical procedure should relate to the diagnosis, as patients with isthmic spondylolisthesis (Grades I and II) are best served with posterolateral fusion without instrumentation, and patients with disc degeneration seem to gain most from instrumented posterolateral fusion or circumferential fusion. COMPLICATIONS: The number of perioperative complications increased with the use of pedicle screw systems to support posterolateral fusions and increased further with the use of circumferential fusions. There was no significant association between outcome result and perioperative complications. The risk of reoperation within 2 years after the spinal fusion procedure was, however, significantly lower for those who had received circumferential fusion in comparison to posterolateral fusion with instrumentation. Furthermore, the risk of non-union was found to be significantly lower for patients who had received circumferential fusion as compared to posterolateral fusion with and without instrumentation. The complications of sexual dysfunction and fusion at non-intended levels were found to be significant but without influence on the overall outcome. REHABILITATION: The patients in the Back-café group performed a succession of many daily tasks significantly better and moreover had less pain compared with both the Video and Training groups 2 years after lumbar spinal fusion. The Video group had significantly greater treatment demands outside the hospital system. This study demonstrates the importance of the inclusion of coping schemes and questions the role of intensive exercises in a rehabilitation program for spinal fusion patients.