Jens Ivar Brox

Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.

Study Design. Single blind randomized study. Objectives. To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Summary of Background Data. To the authors’ best knowledge, only one randomized study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician. Patients and Methods. Sixty-four patients aged 25–60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4–L5 and/or L5–S1 at radiographic examination were randomized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The main outcome measure was the Oswestry Disability Index. Results. At the 1-year follow-up visit, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (−6.7 to 11.4) (P = 0.33). Improvements inback pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment, and lower limb pain was reduced more after surgery. The success rateaccording to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%. Conclusion. The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomized to cognitive intervention and exercises, or lumbar fusion.

Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study.

Abstract The effectiveness of lumbar fusion for chronic low back pain after surgery for disc herniation has not been evaluated in a randomized controlled trial. The aim of the present study was to compare the effectiveness of lumbar fusion with posterior transpedicular screws and cognitive intervention and exercises. Sixty patients aged 25–60 years with low back pain lasting longer than 1 year after previous surgery for disc herniation were randomly allocated to the two treatment groups. Experienced back surgeons performed transpedicular fusion. Cognitive intervention consisted of a lecture intended to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The primary outcome measure was the Oswestry Disability Index (ODI). Outcome data were analyzed on an intention‐to‐treat basis. Ninety‐seven percent of the patients, including seven of eight patients who had either not attended treatment (n = 5) or changed groups (n = 2), completed 1‐year follow‐up. ODI was significantly improved from 47 to 38 after fusion and from 45 to 32 after cognitive intervention and exercises. The mean difference between treatments after adjustment for gender was −7.3 (95% CI −17.3 to 2.7, p = 0.15). The success rate was 50% in the fusion group and 48% in the cognitive intervention/exercise group. For patients with chronic low back pain after previous surgery for disc herniation, lumbar fusion failed to show any benefit over cognitive intervention and exercises.

Arthroscopic surgery compared with supervised exercises in patients with rotator cuff disease (stage II impingement syndrome)

OBJECTIVE--To compare the effectiveness of arthroscopic surgery, a supervised exercise regimen, and placebo soft laser treatment in patients with rotator cuff disease (stage II impingement syndrome). DESIGN--Randomised clinical trial. SETTING--Hospital departments of orthopaedics and of physical medicine and rehabilitation. PATIENTS--125 patients aged 18-66 who had had rotator cuff disease for at least three months and whose condition was resistant to treatment. INTERVENTIONS--Arthroscopic subacromial decompression performed by two experienced surgeons; exercise regimen over three to six months supervised by one experienced physiotherapist; or 12 sessions of detuned soft laser treatment over six weeks. MAIN OUTCOME MEASURES--Change in the overall Neer shoulder score (pain during previous week and blinded evaluation of function and range of movement by one clinician) after six months. RESULTS--No differences were found between the three groups in duration of sick leave and daily intake of analgesics. After six months the difference in improvement in overall Neer score between surgery and supervised exercises was 4.0 (95% confidence interval -2 to 11) and 2.0 (-1.4 to 5.4) after adjustment for sex. The condition improved significantly compared with placebo in both groups given the active treatments. Treatment costs were higher for those given surgery (720 pounds v 390 pounds). CONCLUSIONS--Surgery or a supervised exercise regimen significantly, and equally, improved rotator cuff disease compared with placebo.

Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up.

The effectiveness of arthroscopic surgery, supervised exercises, and placebo was compared in 125 patients with rotator cuff disease (impingement syndrome stage II) in a randomized clinical trial. The median age was 48 years, and the median duration of complications was 1 to 2 years. The treatments were arthroscopic subacromial decompression performed by 2 experienced surgeons, an exercise regimen supervised for 3 to 6 months by 1 experienced physiotherapist, or 12 sessions of detuned soft laser (placebo) for 6 weeks. The criterion for success was a Neer shoulder score > 80. Fifteen (50%) and 11 (22%) of the patients randomized to placebo and exercises, respectively, had surgery during the 2 1/2-year follow-up period and were classified as having failure with the treatments. The success rate was higher (P < .01) for patients randomized to surgery (26 of 38) and exercises (27 of 44) compared with the placebo group (7 of 28). The odds ratio for success after surgery compared with exercises was 1.5 (95% confidence interval 0.6 to 3.7; P = .49). Including all patients who underwent operation, the success rate in those not on sick leave (19 of 21) before surgery was higher compared with those on sick leave (18 of 36) (adjusted odds ratio 5.6 [1.2 to 29.2]). Similar results were observed for patients not receiving versus those receiving regular pain medication before surgery (adjusted odds ratio 4.2 [1.2 to 15.8]).

Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain.

Study Design. Prospective study of two samples of patients with acute and chronic low back pain, respectively. Objectives. To compare the responsiveness of four functional status questionnaires, Roland Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), Disability Rating Index (DRI), and Physical Functioning scale of the SF-36 (PFSF-36), and two pain scales, a Numerical Pain Rating Scale (NRS) and Visual Analogue Scale (VAS). Summary of Background Data. Concurrent comparisons of different outcome measurements in back patients have been requested. Methods. Norwegian versions of the scales and questionnaires were completed by 54 patients with acute (<3weeks) and 50 patients with chronic low back pain (>3 months). Clinical change was estimated on a global change index. An alternative external criterion was the expected clinical course in the two cohorts. Mean changes, standardized response mean (SRM), and area under the receiver operating characteristic (ROC) curves with cutoff point for highest sensitivity and specificity were calculated. Results. At the follow-up, 63% of the acute and 41% of the chronic sample reported improvement on the global change index. Large SRMs (1.3–2.0) and areas under the ROC curves (0.84–0.93) were found for the measurements in the acute sample. In the chronic sample, the SRMs (0.4–1.1) and areas under the ROC curves (0.65–0.83) were lower, in particular for the PFSF-36 and the VAS. There was no statistically significant difference between the responsiveness in the measurements, except for higher responsiveness in the NRS compared with the VAS when using expected clinical course as the external criterion for change. Conclusion. The results suggest that all the outcome measures were appropriate for measuring changes in functional status and pain in patients with acute low back pain, whereas among chronic patients the RMDQ, ODI, DRI, and NRS were most appropriate.

Fear-avoidance beliefs and distress in relation to disability in acute and chronic low back pain

&NA; Patients with chronic low back pain (LBP) frequently demonstrate high scores for fear‐avoidance beliefs and distress. We need better knowledge about fear‐avoidance beliefs and distress in early stages of LBP. The objectives of this study were to compare the level of fear‐avoidance beliefs and distress in patients with acute LBP to patients with chronic LBP, and to assess the relationship of fear‐avoidance beliefs and distress to disability in acute and chronic LBP. Two different back pain groups including 123 patients with acute and 233 patients with chronic LBP were studied. Main outcome measures were Oswestry Disability Index and work loss. The scores for fear‐avoidance beliefs and distress in patients with acute LBP were significantly lower than among patients with chronic LBP. The results of the multivariate regression analyses, adjusting for sociodemographic, pain and clinical variables, demonstrated that whereas fear‐avoidance beliefs for physical activity and distress were significantly associated with the Oswestry Disability Index, fear‐avoidance beliefs for work and distress were significantly associated with work loss. The associations showed the same pattern in acute and chronic LBP. In addition, several of the pain and clinical variables were significantly associated with the Oswestry Disability Index and fingertip–floor distance was associated with work loss. In conclusion, fear‐avoidance beliefs and distress influence pain‐related disability both in early acute and long‐term chronic LBP. The results replicate previous reports on the association between pain experience, fear‐avoidance beliefs, distress, and disability in chronic LBP, and extend the findings to patients at an early stage of acute LBP.

CROSS-CULTURAL ADAPTATION OF THE NORWEGIAN VERSIONS OF THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AND THE OSWESTRY DISABILITY INDEX

OBJECTIVE To evaluate reliability and construct validity of the Norwegian versions of the Roland Morris Disability Questionnaire and the modified Oswestry Disability Index. DESIGN Translation of two functional status questionnaires and a cross-sectional study of measurement properties. METHODS The questionnaires were translated and back-translated following the Guillemin criteria. The Norwegian versions were tested for 55 patients with acute low back pain and 50 patients with chronic low back pain. Test-retest with a 2-day interval was performed in a subsample of 28 patients from the chronic sample. Reliability was assessed by repeatability according to Bland and Altman, intraclass coefficient and coefficient of variation. Internal consistency was assessed by Cronbachs alpha. Concurrent construct validity was assessed with correlations between the questionnaires and the SF-36, Disability Rating Index and pain intensity. RESULTS Repeatability of the Roland Morris Disability Questionnaire was 4 points, coefficient of variation 15% and intraclass correlation coefficient 0.89, and of the modified Oswestry Disability Index 11, 12% and 0.88, respectively. Internal consistency was 0.94 for both questionnaires. The questionnaires correlated highly with the physical functioning scale of SF-36, moderately with pain, and low with mental scales of the SF-36. CONCLUSION The reliability and construct validity of the Norwegian versions of the Roland Morris Disability Questionnaire and the modified Oswestry Disability Index are acceptable for assessing functional status of Norwegian-speaking patients with low back pain.

Clinical course and prognostic factors in acute low back pain : Patients consulting primary care for the first time

Study Design. Inception cohort study. Objectives. To examine the clinical course of acute low back pain and to evaluate prognostic factors for nonrecovery. Summary of Background Data. Few studies have explored clinical course and prognostic factors in patients who consult primary care for their first time because of an episode of low back pain of <3 weeks duration. Methods. A total of 123 patients with acute low back pain <3 weeks consulting primary care for the first time were included, and 120 completed 3 months follow-up. Baseline assessments included sociodemographic characteristics, back pain history and current status, psychological questionnaires and clinical examination. Main outcome measures were pain intensity, disability by Roland Morris Disability Questionnaire, and recovery of disability. Potential prognostic factors for recovery or not were analyzed by multivariate logistic regression. Results. At 4 weeks and 3 months 76% of the patients had recovered. Mean pain intensity and mean disability scores dropped 58% and 68%, respectively, of initial levels during the 3 months. The proportion with sickness absence was 8% at 4 weeks and 6% at 3 months. Several sociodemographic, clinical, and psychological factors were of prognostic value. Compared with their respective reference categories, age above 45 years (odds ratio 4.4, 95% confidence interval 1.4–14.0), smoking (3.0, 1.1–8.5), two or more neurological signs (4.6, 1.4–14.9), a score of ≥90 on the psychosocial screening (3.1, 1.0–9.4), and high levels of distress (4.1, 1.3–12.8) were the best prognostic factors of nonrecovery at 3 months. Conclusion. During a period of 3 months, 24% of the patients had not recovered. Psychological factors and neurological signs were strongly associated with nonrecovery at 3 months. In addition to the traditional examination of neurological symptoms and signs, psychological factors should be considered already at the initial visit of an episode of low back pain.

Functional Status and Disability Questionnaires : What Do They Assess? : A Systematic Review of Back-Specific Outcome Questionnaires

Study Design. A systematic literature review of outcome questionnaires designed for assessing functional status or disability in patients with low back pain. Objectives. To provide a comprehensive overview of all functioning/disability questionnaires used in recent years and to explore how the main concept(s) was described or defined in the original paper, the content or the domains of disability, and the measurement properties of the questionnaires. Summary of Background Data. A number of clinical tools designed for evaluating the functional status of patients with low back pain have been developed. Only a few have been reviewed earlier, and there has been little focus on the content reflected in the questionnaires. Methods. Papers including questionnaires for assessing disability, function, activity limitations, or participation restrictions in adult patients with low back pain were searched in the MEDLINE and CINAHL databases for the period from January 1996 to January 2002. Two independent and blinded researchers read and selected abstracts and questionnaires. The content of the included questionnaires was classified according to World Health Organization’s International Classification of Functioning, Disability and Health. The measurement properties were analyzed according to recommended guidelines. Results. A total of 36 back-specific questionnaires were identified. When distinguishing among a bodily, personal, and social perspective of functioning, 4 main types of content were identified. Most of the outcome questionnaires had a mixed content reflecting various constructs such as pain and symptoms, sleep disturbances, psychological dysfunctions, physical impairments, and social functions. Nine questionnaires assessed solely activities of daily living. For one-third of the questionnaires, the measurement properties were reported in only the original study. Conclusions. Although most questionnaires had their main focus on activity limitations, a considerable variation with respect to the main concept and content was found. Only a few of the questionnaires can be considered acceptably validated.

Clinical course and impact of fear-avoidance beliefs in low back pain: prospective cohort study of acute and chronic low back pain: II.

Study Design. Prospective inception cohort study. Objectives. To compare the clinical course of fear-avoidance beliefs in acute and chronic low back pain (LBP) and investigate the contribution of fear-avoidance beliefs to predict pain and disability after 1 year. Summary of Background Data. Fear-avoidance beliefs are involved in disability development. There is little knowledge on the development of fear-avoidance beliefs among different LBP subgroups. Methods. Patients with acute (n = 123) and chronic (n = 50) LBP completed a comprehensive assessment, including the Fear-Avoidance Beliefs Questionnaire (FABQ), and were followed at 3, 6, 9, and 12 months. Results. At baseline, patients with chronic LBP had significantly higher FABQ-scores for work (FABQ-Work) than patients with acute LBP (P < 0.001), and this difference remained unchanged over 1 year (P > 0.21). At baseline, there was no statistical significant difference in FABQ-scores for physical activity (FABQ-PA) between the two groups (P = 0.57). FABQ-PA scores decreased significantly over the first 4 weeks among patients with acute LBP during follow-up and remained unchanged thereafter, whereas in the chronic sample the FABQ-PA scores were unchanged throughout the first year (time effect, P < 0.001; and interaction effect, P < 0.001). In the acute sample, FABQ-Work predicted pain (P < 0.05) and disability at 12 months (P = 0.01). In the chronic sample, FABQ-PA predicted disability at 12 months (P = 0.03). The associations between the FABQ and pain/disability disappeared with distress included in the models. Conclusion. Patients with chronic LBP had more fear-avoidance beliefs for work than patients with acute LBP. There were small changes in fear-avoidance beliefs during the year of follow-up, except for a rapid decrease during the first month in the FABQ-PA in the acute sample. Fear-avoidance beliefs predicted pain and disability at 12 months after adjusting for socio-demographic and pain variables. Distress was a stronger predictor than fear-avoidance beliefs.