Objective

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).

Results

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.

Conclusion

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.

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.

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.

Methods

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.

Results

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.

Interpretation

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.

Background

To assess safety, risk factors and clinical outcomes in elderly patients with spinal stenosis after decompressive laminectomy.

Methods

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.

Results

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.

Conclusions

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.

Objectives

To compare the long-term effectiveness of surgical and non-surgical treatment in patients with chronic low back pain.

Methods

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.

Results

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.

Conclusions

Long-term improvement was not better after instrumented transpedicular fusion compared with cognitive intervention and exercises.

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.

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.

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.