Eli Molde Hagen

Background: Brief intervention programs are clinically beneficial, and cost efficient treatments for low back pain, when offered at 8-12 weeks, compared with treatment as usual. However, about 30% of the patients do not return to work. The European Guidelines for treatment of chronic low back pain recommends Cognitive Behavioral Therapy (CBT), but conclude that further research is needed to evaluate the effectiveness of CBT for chronic low back pain.Methods/Design: The aim of the multicenter CINS trial (Cognitive Interventions and Nutritional Supplements) is to compare the effectiveness of 4 different interventions; Brief Intervention, Brief Intervention and CBT, Brief Intervention and nutritional supplements of seal oil, and Brief Intervention and nutritional supplements of soy oil. All participants will be randomly assigned to the interventions. The nutritional supplements will be tested in a double blind design. 400 patients will be recruited from a population of chronic low back pain patients that have been sick listed for 2-10 months. Four outpatient clinics, located in different parts of Norway, will participate in recruitment and treatment of the patients.The Brief Intervention is a one session cognitive, clinical examination program based on a non-injury model, where return to normal activity and work is the main goal, and is followed by two booster sessions. The CBT is a tailored treatment involving 7 sessions, following a detailed manual. The nutritional supplements consist of a dosage of 10 grams of either soy or seal oil (capsules) per day for 3 months, administered in a double blind design. All patients will be followed up with questionnaires after 3, 6 and 12 months, while sick leave data will be collected up to at least 24 months after randomization. The primary outcome of the study is sick leave and will be based on register data from the National Insurance Administration. Secondary outcomes include self-reported data on disability, pain, and psychological variables.Conclusions: To our knowledge, the CINS trial will be the largest, randomized trial of psychological and nutritional interventions for chronic low back pain patients to date. It will provide important information regarding the effectiveness of CBT and seal oil for chronic low back pain patients.Trial Registration: http://www.clinicaltrials.gov, with registration numberNCT00463970.

Aims: To investigate if a standardised physical exercise programme given in addition to a brief intervention at a spine clinic had an effect on return to work. Methods: A total of 246 patients sick-listed 8—12 weeks for non-specific low back pain were offered a brief intervention programme at the spine clinic with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible, before they were randomised into an intervention group (n = 124) and a control group (n = 122). Patients in the intervention group participated in a physical exercise programme at the spine clinic. Results: During the 2-year follow-up, there were no significant differences between the groups on sick leave, pain, use of analgesics, psychological distress, coping strategies, fear-avoidance beliefs, self-reported disability, or walking distances. However, both groups increased return to work, reported less pain and better function, and reduced fear-avoidance beliefs for physical activity during the follow-up period. Fear-avoidance beliefs for work were not changed. Conclusions: A physical exercise programme for low back pain patients given after a brief intervention at a spine clinic did not have any additional effect on sick leave or fear-avoidance beliefs. Both groups reported less pain, better physical function, and increased return to work during follow-up. The treatment at the spine clinic did not contain a vocational rehabilitation programme directed towards individual work-related problems, which might explain no change in fear-avoidance beliefs for work.

Brief intervention programs for subacute low back pain (LBP) result in significant reduction of sick leave compared to treatment as usual. Although effective, a substantial proportion of the patients do not return to work. This study investigates predictors of return to work in LBP patients participating in a randomized controlled trial comparing a brief intervention program (BI) with BI and physical exercise.

Cross-sectional study. To compare subjective health complaints in subacute patients with low back pain with reference values from a Norwegian normal population. Comorbidity is common with nonspecific low back pain. We wanted to investigate if these complaints were specific or part of a more general unspecific condition comparable to subjective health complaints in the normal population. The study group consisted of 457 patients sick-listed 8 to 12 weeks for low back pain. All subjects filled out questionnaires. The subjective health complaints in the study group were compared with reference values from a Norwegian normal population using logistic regression analysis. Compared with the normal reference population, the patients with low back pain had significantly more low back pain, neck pain, upper back pain, pain in the feet during exercise, headache, migraine, sleep problems, flushes/heat sensations, anxiety, and sadness/depression. The prevalence of pain in arms, pain in shoulders, and tiredness was also high, but not significantly higher than in the reference population. Our findings indicate that patients with low back pain suffer from what may be referred to as a “syndrome,” consisting of muscle pain located to the whole spine as well as to legs and head, and accompanying sleep problems, anxiety, and sadness/depression.

Modifying effects in multivariate analyses of a randomized controlled trial. To identify prognostic factors for the effect of a brief intervention (“modifiers”) at a spine clinic on return to work in patients with subacute low back pain. A previous study of a brief intervention showed significant reduction of sick leave, compared with usual primary healthcare treatment. Randomized controlled trials give data only on the group as an average. Identifying prognostic factors that interact with the treatment (“modifiers”) may identify specific groups requiring this or other types of treatment. A total of 457 patients who had been sick-listed 8 to 12 weeks for low back pain were randomized into an intervention group (spine clinic with medical examination, information, reassurance, encouragement to engage in physical activity, n = 237), and a control group (primary health care, n = 220). All subjects filled out questionnaires. Logistic regression and tests for interaction were used to identify prognostic factors and modifiers for return to work in the two groups, at 3 and 12 months of follow-up. At 3 months of follow-up, the strongest modifying effect on return to work was the perception of constant back strain when working and beliefs about reduced ability to work. At 12 months, gastrointestinal complaints were the strongest modifier for the effect of the intervention. The spine clinic intervention seems to have a main effect on work absenteeism via interacting with the concerns of being unable to work.

A controlled randomized clinical trial was performed. To investigate the effect of a light mobilization program on the duration of sick leave for patients with subacute low back pain. Early intervention with information, diagnostics, and light mobilization may be a cost-effective method for returning patients quickly to normal activity. In this experiment, patients were referred to a low back pain clinic and given this simple and systematic program as an outpatient treatment. In this study, 457 patients sick-listed 8 to 12 weeks for low back pain, as recorded by the National Insurance Offices, were randomized into two groups: an intervention group (n = 237) and a control group (n = 220). The intervention group was examined at a spine clinic and given information and advice to stay active. The control group was not examined at the clinic, but was treated with conventional primary health care. At 12-month follow-up assessment, 68.4% in the intervention group had returned to full-duty work, as compared with 56.4% in the control group. Early intervention with examination, information, and recommendations to stay active showed significant effects in reducing sick leave for patients with low back pain.