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1.  Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients 
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).
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.
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.
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).
PMCID: PMC4875713  PMID: 27206497
Lumbar spinal fusion; Low back pain; Cognitive-behavioural therapy; Acute postsurgical pain; Mobility; Randomised controlled trial
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 
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.
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.
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.
PMCID: PMC3973885  PMID: 24581321
Spine surgery; Chronic low back pain; Rehabilitation; Cognitive-behavioural therapy; Randomized clinical trial
3.  The Canadian Occupational Performance Measure’s semi-structured interview: its applicability to lumbar spinal fusion patients. A prospective randomized clinical study 
European Spine Journal  2011;21(1):115-121.
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
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.
PMCID: PMC3252452  PMID: 21863462
Activities of daily living (ADL); Canadian Occupational Performance Measure (COPM); Occupational therapy; Rehabilitation; Lumbar spinal fusion
4.  Microdialysis of paraspinal muscle in healthy volunteers and patients underwent posterior lumbar fusion surgery 
European Spine Journal  2009;18(11):1604-1609.
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 μM in the paraspinal muscle and 118.9 ± 79.8 μM in the deltoid muscle in the surgery group. Mean glycerol concentration difference (GCD) between the paraspinal muscle and the deltoid tissue was 124.1 μM (P = 0.003, with 95% confidence interval 83.4–164.9 μM). 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.
PMCID: PMC2899392  PMID: 19418074
Glucose; Lactate pyruvate ratio; Glycerol; Paraspinal muscle; Microdialysis
5.  Early Clinical & Radiographic Results of NFix II Posterior Dynamic Stabilization System 
SAS Journal  2008;2(2):69-75.
Complications associated with rigid posterior instrumented fusions of the lumbar spine include pseudarthrosis, accelerated adjacent-segment disease, hardware failure, and iatrogenic fixed sagittal imbalance. Posterior pedicle screw/rod-based dynamic stabilization systems, in which semirigid rods or cords are used to restrict or control, rather than completely eliminate spinal segmental motion, aim to reduce or eliminate these fusion-associated drawbacks. In this study, we analyzed the early radiographic and clinical outcomes of patients treated with the NFix II System (N Spine, Inc., San Diego, California), a novel pedicle screw/ rod-based system used as a nonfusion posterior dynamic stabilization system, and compared our results to those of similar systems currently in use.
Seven sites participated in a retrospective assessment of 40 consecutive patients who underwent dynamic stabilization of the lumbar spine with the NFix II System at a single level. (One patient underwent 2 single-level dynamic constructs at noncontiguous levels (L3-4 and L5-S1).) Patients were included based on the presence of spinal stenosis, degenerative spondylolisthesis, adjacent segment degeneration, recurrent disc herniation, symptomatic degenerative disc disease, and degenerative scoliosis requiring dynamic stabilization at 1 level with or without instrumented rigid fusion at a contiguous level. Participants were evaluated preoperatively, with planned postoperative assessments at 3 and 6 weeks (1 center assessed patients at 4 weeks), 3 months, 6 months, and 12 months. The primary clinical outcome measures at each assessment were visual analogue scale (VAS) scores to measure back pain, and Oswestry Disability Index (ODI)1 scores to measure function. Radiographic outcome measurements included evidence of instrumentation failure and range of motion (ROM) based on postoperative flexion-extension radiographs at 3, 6, and 12 months.
Forty patients (15males, 25 females) with a mean age of 55 years (range 21–81) were included. Average follow-up was 8.1 months (range 6–12). The mean VAS score improved from 7.6 preoperatively to 3.3 postoperatively (P < .001), and the ODI score from 47.3 to 22.8 (P < .001). Eighty percent of patients were severely disabled or worse (ODI ≥ 41) preoperatively, which was reduced to 13% postoperatively. Of the 10 patients with more than 6 months’ follow-up, only 4 demonstrated adequate flexion/extension effort. ROM measurements in those 4 patients showed that on average 53% of preoperative segmental motion was retained at the dynamically stabilized level 6 months postoperatively. There were no instrumentation-related complications.
Results of this limited study indicate that the NFix II System when used as a nonfusion device for dynamic stabilization produces significant improvements in pain and function at short-term follow-up with outcomes comparable to other dynamic stabilization systems. The use of this system was not associated with an increased risk of instrumentation failure. The small number of patients with postoperative severe disability or worse compares favorably to long-term published data on posterolateral fusion. Lastly, in this small sample, ROM was preserved at 6-month follow-up.
Clinical Relevance
Posterior pedicle screw/rod dynamic stabilization using the NFix II System seems very effective in improving pain and function scores, at least in the short term (mean postoperative ODI of 22.8). Preservation of ROM is also possible. Longerterm follow-up is necessary to assess sustained clinical improvement, hardware complications, and maintenance in segmental ROM. The NFix II System may be considered an effective alternative to existing dynamic stabilization systems. This device is cleared by the US Food and Drug Administration for use as an adjunct to fusion and has the European CE Marking for use in both fusion and nonfusion applications.
PMCID: PMC4365829  PMID: 25802605
Lumbar spine; posterior dynamic stabilization; spinal fusion
6.  Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain 
European Spine Journal  2006;16(5):657-668.
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.
PMCID: PMC2213550  PMID: 16871387
Economic evaluation; Cost-effectiveness; Lumbar spinal fusion; Methods; Low back pain
7.  Outcome in adolescent idiopathic scoliosis after brace treatment and surgery assessed by means of the Scoliosis Research Society Instrument 24 
European Spine Journal  2005;15(7):1108-1117.
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.
PMCID: PMC3233940  PMID: 16308724
Scoliosis; Quality of life; Functional outcome; Brace; Surgery
8.  Healing properties of allograft from alendronate-treated animal in lumbar spine interbody cage fusion 
European Spine Journal  2004;14(3):222-226.
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.
PMCID: PMC3476744  PMID: 15248057
Anterior lumbar interbody fusion (ALIF); Bisphosphonate; Bone graft; Cage; CT

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