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1.  Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study 
BMJ Open  2014;4(3):e004651.
This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. At present, many spine surgeons perform microdecompression for central lumbar spinal stenosis.
Methods and analysis
Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery. The primary outcome measure is change in Oswestry disability index between baseline and 12-month follow-up. Secondary outcome measures are changes in health-related quality of life measured by the Euro-Qol-5D between baseline and 12-month follow-up, perioperative complications, and duration of surgical procedures and length of hospital stay.
Ethics and dissemination
The study has been evaluated and approved by the regional committee for medical research in central Norway and all participants provided written informed consent. The findings of this study will be disseminated through peer-reviewed publications.
Trial registration number (NCT02006901).
PMCID: PMC3963092  PMID: 24650809
2.  Modic type I changes and recovery of back pain after lumbar microdiscectomy 
European Spine Journal  2012;21(11):2252-2258.
To investigate whether the presence of Modic changes type I (MC I) found on preoperative MRI scans represent a risk factor for persistent back pain 12 months after surgery amongst patients operated for lumbar disc herniation.
Cohort study of 178 consecutive patients operated with lumbar microdiscectomy. Preoperative MRI scans were evaluated by two independent neuroradiologists. Primary outcome measure was the visual analogue scale (VAS) for back pain. Secondary outcome measures were; VAS for leg pain, physical function (Oswestry Disability Index), and health-related quality of life (EQ-5D), self-reported benefit of the operation and employment status. The presence of MC I was used as exposition variable and adjusted for other risk factors in multivariate analyses.
The Modic classification showed a high inter-observer reproducibility. Patients with MC I had less improvement of back pain 12 months after surgery, compared to those who had no or other types of MC, but this negative association no longer showed statistical significance when adjusted for smoking, which remained the only independent risk factor for persistent back pain.
Patients with preoperative MC I can expect less but still significant improvement of back pain 1 year after microdiscectomy, but not if they smoke cigarettes.
PMCID: PMC3481096  PMID: 22842978
Clinical outcome; Microdiscectomy; Low back pain; Modic changes; Smoking
3.  Accuracy of physical examination for chronic lumbar radiculopathy 
Clinical examination of patients with chronic lumbar radiculopathy aims to clarify whether there is nerve root impingement. The aims of this study were to investigate the association between findings at clinical examination and nerve root impingement, to evaluate the accuracy of clinical index tests in a specialised care setting, and to see whether imaging clarifies the cause of chronic radicular pain.
A total of 116 patients referred with symptoms of lumbar radiculopathy lasting more than 12 weeks and at least one positive index test were included. The tests were the straight leg raising test, and tests for motor muscle strength, dermatome sensory loss, and reflex impairment. Magnetic resonance imaging (n = 109) or computer tomography (n = 7) were imaging reference standards. Images were analysed at the level of single nerve root(s), and nerve root impingement was classified as present or absent. Sensitivities, specificities, and positive and negative likelihood ratios (LR) for detection of nerve root impingement were calculated for each individual index test. An overall clinical evaluation, concluding on the level and side of the radiculopathy, was performed.
The prevalence of disc herniation was 77.8%. The diagnostic accuracy of individual index tests was low with no tests reaching positive LR >4.0 or negative LR <0.4. The overall clinical evaluation was slightly more accurate, with a positive LR of 6.28 (95% CI 1.06–37.21) for L4, 1.74 (95% CI 1.04–2.93) for L5, and 1.29 (95% CI 0.97–1.72) for S1 nerve root impingement. An overall clinical evaluation, concluding on the level and side of the radiculopathy was also performed, and receiver operating characteristic (ROC) analysis with area under the curve (AUC) calculation for diagnostic accuracy of this evaluation was performed.
The accuracy of individual clinical index tests used to predict imaging findings of nerve root impingement in patients with chronic lumbar radiculopathy is low when applied in specialised care, but clinicians’ overall evaluation improves diagnostic accuracy slightly. The tests are not very helpful in clarifying the cause of radicular pain, and are therefore inaccurate for guidance in the diagnostic workup of the patients. The study population was highly selected and therefore the results from this study should not be generalised to unselected patient populations in primary care nor to even more selected surgical populations.
PMCID: PMC3716914  PMID: 23837886
Sensitivity; Accuracy; Likelihood ratio; Lumbar radiculopathy; Physical examination
4.  Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease 
The need for cost effectiveness analyses in randomized controlled trials that compare treatment options is increasing. The selection of the optimal utility measure is important, and a central question is whether the two most commonly used indexes - the EuroQuol 5D (EQ5D) and the Short Form 6D (SF6D) – can be used interchangeably. The aim of the present study was to compare change scores of the EQ5D and SF6D utility indexes in terms of some important measurement properties. The psychometric properties of the two utility indexes were compared to a disease-specific instrument, the Oswestry Disability Index (ODI), in the setting of a randomized controlled trial for degenerative disc disease.
In a randomized controlled multicentre trial, 172 patients who had experienced low back pain for an average of 6 years were randomized to either treatment with an intensive back rehabilitation program or surgery to insert disc prostheses. Patients filled out the ODI, EQ5D, and SF-36 at baseline and two-year follow up. The utility indexes was compared with respect to measurement error, structural validity, criterion validity, responsiveness, and interpretability according to the COSMIN taxonomy.
At follow up, 113 patients had change score values for all three instruments. The SF6D had better similarity with the disease-specific instrument (ODI) regarding sensitivity, specificity, and responsiveness. Measurement error was lower for the SF6D (0.056) compared to the EQ5D (0.155). The minimal important change score value was 0.031 for SF6D and 0.173 for EQ5D. The minimal detectable change score value at a 95% confidence level were 0.157 for SF6D and 0.429 for EQ5D, and the difference in mean change score values (SD) between them was 0.23 (0.29) and so exceeded the clinical significant change score value for both instruments. Analysis of psychometric properties indicated that the indexes are unidimensional when considered separately, but that they do not exactly measure the same underlying construct.
This study indicates that the difference in important measurement properties between EQ5D and SF6D is too large to consider them interchangeable. Since the similarity with the “gold standard” (the disease-specific instrument) was quite different, this could indicate that the choice of index should be determined by the diagnosis.
PMCID: PMC3648434  PMID: 23622053
Utility measures; Outcome assessment; Measurement properties; Health economics; Low back pain; Lumbar disc prosthesis; EQ5D; SF6D
5.  Recovery of muscle strength after microdiscectomy for lumbar disc herniation: a prospective cohort study with 1-year follow-up 
European Spine Journal  2011;21(4):655-659.
Surgery has not been proven to be a better treatment option than non-operative management for limb paresis due to lumbar disc herniation. For the patients it will still be a concern, whether they will regain full strength after the operation or not.
A prospective cohort study of 91 patients with preoperative paresis due to disc herniation with 1-year follow up was carried out. The primary outcome was muscle strength in affected limb, and the secondary outcome was self-reported symptoms on back and leg pain, disability, health related quality of life, general health and working capability.
Seventy-five percent of patients had no paresis 1 year after the operation. The severity of the paresis was the only predictor for persistent paresis. Preoperative duration of the paresis did not influence the rate of full recovery. Non-recovery was associated with inferior outcomes and higher risk for reduced working capability.
The majority of patients with paresis were fully recovered 1 year after microdiscectomy for lumbar disc herniation. If the paresis was severe at baseline, there was a four times higher risk for non-recovery. Patients who did not recover had significantly worse outcomes.
PMCID: PMC3326133  PMID: 22193841
Lumbar spine; Disc herniation; Microdiscectomy; Limb paresis; Intervertebral disk
6.  Assessment of referrals to a multidisciplinary outpatient clinic for patients with back pain 
Each year our multidisciplinary outpatient clinic for patients with back pain receives a large number of referrals from primary care physicians, manual physiotherapists, and chiropractors. We wanted to assess the quality of the referrals regarding the information provided about case history, clinical findings, and results from additional investigations.
Material and methods
Two hundred and eighty six consecutive referrals received in the time period from 1 October 2008 to 1 March 2009 were reviewed. We investigated if the referrals contained 12 given items. The items were defined by consensus of the broad range of specialists working at the multidisciplinary outpatient clinic. All registered items were regarded as useful when assigning patients with a priority and appropriate caregiver at the outpatient clinic. The 12 items that our group felt were reflective of good referrals were information about occupational status, duration of symptoms, pain distribution, sensory symptoms, use of analgesics, alleviating and/or aggravating factors, systems enquiry (i.e. urination, bowel movements, and sleep), provided treatment, deep tendon reflexes, motor function, sensory examination, and radiculopathy tests (i.e. straight leg raise and/or foraminal compression test).
Two hundred and fifty six (89·5%) referrals were from primary care physicians, and the remaining came from physicians in internships, manual physiotherapists, and chiropractors. Six (2·1%) referrals contained all 12 items. On average each referral contained 5·95 items (95% CI: 5·66–6·25). Information about analgesics, sensory symptoms, systems enquiry, and alleviating and aggravating factors was most frequently missing. Information about provided treatment, motor function, deep tendon reflexes, clinical tests, and occupational status was included in about half of the referrals. In 27·3% of the referrals from primary care physicians information about clinical findings was missing. Referrals from manual physiotherapists contained statistically significant more information (9·67 items, 95% CI: 7·63–11·70) than from the other groups (P<0·001). The number of patients registered with each primary care physician did not affect the number of items in the referrals.
Many of the referrals were inadequate. Inadequate referrals can lead to prolonged waiting time for examination and treatment. Referrals with relevant information about patient history and clinical findings are essential in order to assign patients with an appropriate caregiver at the outpatient clinic and to determine if and which diagnostic imaging findings are of clinical relevance.
PMCID: PMC3267443  PMID: 22412296
Manual therapy; Primary care; Spinal; Specialist care; Referrals
7.  Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study 
Objective To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain.
Design A prospective randomised multicentre study.
Setting Five university hospitals in Norway.
Participants 173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007.
Interventions Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days.
Main outcome measures The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients’ satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up.
Results The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of −8.4 points (95% confidence interval −13.2 to −3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference −12.2, −21.3 to −3.1), patients’ satisfaction (63% (n=46) v 39% (n=26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5).
Conclusions Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making.
Trial registration NCT 00394732.
PMCID: PMC3100911  PMID: 21596740
8.  Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? 
Acta Orthopaedica  2011;82(1):56-63.
Background and purpose
Loss to follow-up may bias the outcome assessments of clinical registries. In this study, we wanted to determine whether outcomes were different in responding and non-responding patients who were included in a clinical spine surgery registry, at two years of follow-up. In addition, we wanted to identify risk factors for failure to respond.
633 patients who were operated for degenerative disorders of the lumbar spine were followed for 2 years using a local clinical spine registry. Those who did not attend the clinic and those who did not answer a postal questionnaire—for whom 2 years of outcome data were missing—and who would be lost to follow-up according to the standard procedures of the registry protocols, were defined as non-respondents. They were traced and interviewed by telephone. Outcome measures were: improvement in health-related quality of life (EQ-5D), leg pain, and back pain; and also general state of health, employment status, and perceived benefits of the operation.
We found no statistically significant differences in outcome between respondents (78% of the patients) and non-respondents (22%). Receipt of postal questionnaires (not being summoned for a follow-up visit) was the strongest risk factor for failure to respond. Forgetfulness appeared to be an important cause. Older patients and those who had complications were more likely to respond.
A loss to follow-up of 22% would not bias conclusions about overall treatment effects and, importantly, there were no indications of worse outcomes in non-respondents.
PMCID: PMC3229998  PMID: 21189113
9.  Clinical outcomes and safety assessment in elderly patients undergoing decompressive laminectomy for lumbar spinal stenosis: a prospective study 
BMC Surgery  2010;10:34.
To assess safety, risk factors and clinical outcomes in elderly patients with spinal stenosis after decompressive laminectomy.
A prospective cohort of patients 70 years and older with spinal stenosis undergoing conventional laminectomy without fusion (n = 101) were consecutively enrolled from regular clinical practice and reassessed at 3 and 12 months. Primary outcome was change in health related quality of life measured (HRQL) with EuroQol-5 D (EQ-5D). Secondary outcomes were safety assessment, changes in Oswestry disability index (ODI), Visual Analogue Scale (EQ-VAS) score for self reported health, VAS score for leg and back pain and patient satisfaction. We used regression analyses to evaluate risk factors for less improvement.
The mean EQ-5 D total score were 0.32, 0.63 and 0.60 at baseline, 3 months and 12 months respectively, and represents a statistically significant (P < 0.001) improvement. Effect size was > 0.8. Mean ODI score at baseline was 44.2, at 3 months 25.6 and at 27.9. This represents an improvement for all post-operative scores. A total of 18 (18.0%) complications were registered with 6 (6.0%) classified as major, including one perioperative death. Patients stating that the surgery had been beneficial at 3 months was 82 (89.1%) and at 12 months 73 (86.9%). The only predictor found was patients with longer duration of leg pain had less improvement in ODI (P < 0.001). Increased age or having complications did not predict a worse outcome in any of the outcome variables.
Properly selected patients of 70 years and older can expect a clinical meaningful improvement of HRQL, functional status and pain after open laminectomy without fusion. The treatment seems to be safe. However, patients with longstanding leg-pain prior to operation are less likely to improve one year after surgery.
PMCID: PMC2996343  PMID: 21092227
10.  Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain 
Annals of the Rheumatic Diseases  2010;69(9):1643-1648.
To compare the long-term effectiveness of surgical and non-surgical treatment in patients with chronic low back pain.
Two merged randomised clinical trials compared instrumented transpedicular fusion with cognitive intervention and exercises in 124 patients with disc degeneration and at least 1 year of symptoms after or without previous surgery for disc herniation. The main outcome measure was the Oswestry disability index.
At 4 years 14 (24%) patients randomly assigned to cognitive intervention and exercises had also undergone surgery. 15 (23%) patients assigned fusion had undergone re-surgery. The mean treatment effect for the primary outcome was 1.1; 95% CI −5.9 to 8.2, according to the intention-to-treat analysis and −1.6; 95% CI −8.9 to 5.6 in the as-treated analysis. There was no difference in return to work.
Long-term improvement was not better after instrumented transpedicular fusion compared with cognitive intervention and exercises.
PMCID: PMC2938881  PMID: 19635718
11.  Comparing precision of distortion-compensated and stereophotogrammetric Roentgen analysis when monitoring fusion in the cervical spine 
European Spine Journal  2005;15(6):774-779.
Two methods to measure sagittal plane segmental motion in the cervical spine are compared. Translational and rotational motion was measured in nine cervical motion segments of nine patients by distortion-compensated (DCRA) as well as by stereophotogrammetric Roentgen analysis (RSA). To compare measurement precision of the new DCRA protocol with the established RSA technique under realistic clinical conditions and to discuss advantages and disadvantages of both methods in clinical studies. RSA constitutes the most precise method available to assess segmental motion or to monitor fusion in the cervical spine. Due to the invasive nature of the procedure there is an interest in alternative, non-invasive protocols, based on conventional, lateral radiographic views. In nine patients, segmental motion of nine cervical segments with spinal surgery and fusion had previously been assessed from stereo views by RSA. From the archive radiographs, sagittal plane segmental motion was re-assessed by DCRA. Results for sagittal plane translational and rotational motion obtained by both methods are compared. With respect to RSA, sagittal plane rotation was determined by DCRA with an error of 2.4° and a mean difference not significantly different from zero. Sagittal plane translation was determined by DCRA with an error of less than 0.78 mm and a mean difference not significantly different from zero. As two methods are compared, these errors represent the combined (propagated) errors of RSA and DCRA. Averaged over the cohort investigated, measurement of sagittal plane segmental motion exhibited no significant difference between DCRA and RSA.
PMCID: PMC3489461  PMID: 16163513
Cervical spine; Fusion; Sagittal plane segmental mobility; Sagittal plane rotation; Sagittal plane translation
12.  The risk of “getting worse” after lumbar microdiscectomy 
European Spine Journal  2004;14(1):49-54.
A frequent concern among patients operated for lumbar disc herniation is the risk of “getting worse”. To give an evidence-based estimate of the risk for worsening has been difficult, since previous studies have been more focused on unfavourable outcome in general, rather than on deterioration in particular. In this prospective study of 180 patients, we report the frequency of and the risk factors for getting worse after first time lumbar microdiscectomy. Follow-up time was 12 months. Primary outcome measure was the Oswestry disability index, assessing functional status and health-related quality of life. Of the patients 4% got worse. Independent risk factors of deterioration were a long duration of sick leave and a better functional status and quality of life prior to operation. We conclude that the risk of deterioration is small, but larger if the patient has been unable to work despite relatively small health problems. This study also demonstrates that changes in instrument scores should be reported, so that an accurate failure rate can be assessed.
PMCID: PMC3476683  PMID: 15138862
Lumbar discectomy; Outcome; Failed back; Prognostic factors
13.  Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial 
Objective To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks).
Design Multicentre, blinded, randomised controlled trial.
Setting Outpatient multidisciplinary back clinics of five Norwegian hospitals.
Participants Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity.
Interventions Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval.
Main outcome measures Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain.
Results Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n=40), estimated change in the Oswestry disability index from the adjusted baseline value was −4.7 (95% confidence intervals −0.6 to −8.8) at 6 weeks, −11.4 (−6.3 to −14.5) at 12 weeks, and −14.3 (−10.0 to −18.7) at 52 weeks. For the epidural saline intervention group (n=39) compared with the sham group, differences in primary outcome were −0.5 (−6.3 to 5.4) at 6 weeks, 1.4 (−4.5 to 7.2) at 12 weeks, and −1.9 (−8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were −2.9 (−8.7 to 3.0), 4.0 (−1.9 to 9.9), and 1.9 (−4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend.
Conclusions Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy.
Trial registration Current Controlled Trials ISRCTN No 12574253.
PMCID: PMC3172149  PMID: 21914755

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