Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, randomised, sham-controlled trial.

OBJECTIVES: To assess whether radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses is more effective than advice plus customised foot orthoses alone in alleviating heel pain in patients with plantar fasciopathy. METHODS: 200 patients with plantar fasciopathy were included in a four-arm, parallel-group, sham-controlled, observer-blinded, partly patient-blinded trial. At baseline, before randomisation, all patients received advice plus customised foot orthoses. Patients were randomised to rESWT (n=50), sham-rESWT (n=50), exercise (n=50) or advice plus customised foot orthoses alone (n=50). Patients in the rESWT and sham-rESWT groups received three treatments. The exercise programme comprised two exercises performed three times a week for 12 weeks, including eight supervised sessions with a physiotherapist. Patients allocated to advice plus customised foot orthoses did not receive additional treatment. The primary outcome was change in heel pain during activity in the previous week per Numeric Rating Scale (0-10) from baseline to 6-month follow-up. The outcome was collected at baseline, and 3, 6 and 12 months. RESULTS: The primary analysis showed no statistically significant between-group differences in mean change in heel pain during activity for rESWT versus advice plus customised foot orthoses (-0.02, 95% CI -1.01 to 0.96), sham-rESWT versus advice plus customised foot orthoses (0.52, 95% CI -0.49 to 1.53) and exercise versus advice plus customised foot orthoses (-0.11, 95% CI -1.11 to 0.89) at 6 months. CONCLUSION: In patients with plantar fasciopathy, there was no additional benefit of rESWT, sham-rESWT or a standardised exercise programme over advice plus customised foot orthoses in alleviating heel pain. TRIAL REGISTRATION NUMBER: NCT03472989.

Efficacy of naproxen in patients with sciatica: multicentre, randomized, double-blind, placebo-controlled trial.

ABSTRACT: This trial assessed the efficacy of naproxen in patients with sciatica in outpatient clinics across 4 Norwegian hospitals. A total of 123 adults with radiating pain below the knee (≥4 on a 0-10 numeric rating scale) and signs consistent with nerve root involvement were included. Participants were randomized to receive either naproxen 500 mg or a placebo twice daily for 10 days. The primary outcome, daily leg pain intensity measured on a 0 to 10 numeric rating scale throughout the treatment period, revealed a statistically significant difference in favor of naproxen, with an adjusted mean difference of -0.5 (95% CI -0.8 to -0.1, P = 0.015). In the naproxen group, the treatment effect was significantly related to time, and over the whole 10-day period, the average adjusted difference was -0.6 (95% CI -0.8 to -0.5). Mean numbers needed to treat for 30% and 50% improvement were 9.9 (95% CI 4.7-15.0) and 20.7 (8.7-32.7), respectively. The adjusted mean difference for back pain was -0.4 (95% CI -0.8 to 0.0), and for Roland Morris Disability Questionnaire for Sciatica, it was -1.5 (95% CI -3.0 to 0.0). No differences were found for sciatica bothersomeness or consumption of rescue medication or opioids. Participants in the naproxen group exhibited an adjusted odds ratio of 4.7 (95% CI 1.3-16.2) for improvement by 1 level on the global perceived change scale. In conclusion, naproxen treatment showed small, likely clinically unimportant benefits compared with placebo in patients with moderate-to-severe sciatica.

The Fear Avoidance Beliefs Questionnaire (FABQ) Does it Really Measure Fear Beliefs?

STUDY DESIGN: A cohort study with 12 months of follow-up. OBJECTIVE: To assess (1) the unidimensionality of the Fear-Avoidance Beliefs Questionnaire (FABQ) and (2) whether single questions in the FABQ predict future sickness absence as well as the whole scale. SUMMARY OF BACKGROUND DATA: The fear-avoidance model is a leading model in describing the link between musculoskeletal pain and chronic disability. However, reported measurement properties have been inconsistent regarding the FABQ. METHODS: Individuals (n = 722) sick listed due to musculoskeletal, unspecified or common mental health disorders undergoing rehabilitation was included. A Rasch analysis was applied to evaluate the measurement properties of FABQ and its two subscales (physical activity and work). Linear regression was used to assess how well single items predicted future sickness absence. RESULTS: The Rasch analysis did not support the FABQ or its two subscales representing a unidimensional construct. The 7-point scoring of the items was far too fine meshed and in the present population the data only supported a yes or no or a 3-point response option. The items were invariant to age, whereas two of the items revealed sex differences. The item "I do not think that I will be back to my normal work within 3 months" was the best predictor of future sickness absence. Adding the item "I should not do my regular work with my present pain" improved the prediction model slightly. CONCLUSION: The FABQ is not a good measure of fear-avoidance beliefs about work or physical activity, and the predictive property of the FABQ questionnaire is most likely related to expectations rather than fear. Based on these results we do not recommend using the FABQ to measure fear-avoidance beliefs. LEVEL OF EVIDENCE: 1.

Tverrfaglig behandlingstilbud til pasienter med ryggsmerter ved et lokalsykehus.

BACKGROUND: Low back pain is considered to be the most common single cause of sickness absence. In 2010, Sørlandet Hospital Arendal established an interdisciplinary treatment programme through the Faster Return-to-Work scheme, based on the relevant guidelines for patients with low back pain. In this study we present our experiences from six years of the treatment programme. MATERIAL AND METHOD: Patients who were referred to Sørlandet Hospital in Arendal in the period 2011-16 due to long-term symptoms of low back pain were offered interdisciplinary treatment. This included a one-to-one consultation with a doctor, four weeks of group-based low back school, and physiotherapist-led exercise as well as eight weeks of either physiotherapist-led exercise or home exercise. The degree of sick leave and functional level using scores on the Roland-Morris Disability Questionnaire (RMDQ) were reported at the outset and after 4 and 12 weeks. RESULTS: A total of 43 patients in employment completed the treatment programme. The average age was 41.9 years and 52 % were women. Altogether 57 % were on certified sick leave at the outset and the remainder were assessed as being at high risk of going on sick leave. A total of 7.5 % were placed on sick leave during the observation period, while 28.5 % of those on sick leave were declared completely fit. Altogether 52.7 % of the patients had a clinically significant reduction in RMDQ scores (> 3.5 points). INTERPRETATION: The interdisciplinary treatment programme appears to improve function and reduce sickness absent in patients with long-term low back pain. This study has a short follow-up time and no control group; the observations must therefore be interpreted with caution.

Five-year development of lumbar disc degeneration-a prospective study.

OBJECTIVE: To examine the impact of demographic, clinical, and genetic factors as well as herniated discs on 5-year development of disc degeneration in the lumbar spine, and to investigate associations between changes in lumbar degenerative findings and pain. MATERIALS AND METHODS: In 144 patients with lumbar radicular pain or low back pain, we scored disc degeneration, herniated discs, and high-intensity zones in the posterior annulus fibrosus on lumbar magnetic resonance imaging (MRI) at baseline and 5-year follow-up. Genotyping (TaqMan assay) was performed for genes encoding vitamin D receptor (VDR), collagen XIα (COL11A), matrix metalloproteinase 1/9 (MMP1/MMP9), and interleukin 1α/1RN (IL-1α/IL-1RN). Associations were analyzed using multivariate linear regression adjusted for age, sex, smoking, body mass index, and baseline scores for degenerated discs and herniated discs (when analyzing impact of baseline factors) or for pain (when analyzing associations with pain). RESULTS: Progression of disc degeneration over 5 years was significantly (p < 0.001) related to higher age and less disc degeneration at baseline, but not to sex, smoking, body mass index, herniated discs, or variants in the studied genes. No associations were identified between changes in disc degeneration or high-intensity zones and pain at 5-year follow-up. However, increased number of herniated discs over 5 years was associated with pain at rest (p = 0.019). CONCLUSIONS: Age and disc degeneration at baseline, rather than genetic factors, influenced the 5-year development of disc degeneration in patients with lumbar radicular pain or low back pain. Development of herniated discs was related to pain at rest.

Demand, Control and Support at Work Among Sick-Listed Patients with Neck or Back Pain: A Prospective Study.

Purpose The main aim of this study was to assess changes in perceived demand, control and support at work of neck and back pain patients over 1 year. We also hypothesised that perceived changes in demand, control and support at work were associated with clinical improvement, reduced fear-avoidance beliefs and successful return to work. Methods Four hundred and five sick-listed patients referred to secondary care with neck or back pain were originally included in an interventional study. Of these, two hundred and twenty-six patients reported perceived psychosocial work factors at both baseline and 1-year follow-up, and they were later included in this prospective study. Changes in demand, control and support dimensions were measured by a total of nine variables. Results At the group level, no significant differences were found among the measured subscales. At the individual level, the regression analyses showed that decreases in fear-avoidance beliefs about work were consistently related to decreases in demand and increases in control, whereas decreases in disability, anxiety and depression were related to increases in support subscales. Conclusions The perception of demand, control and support appear to be stable over 1 year in patients with neck and back pain, despite marked improvement in pain and disability. Disability, anxiety, depression and fear-avoidance beliefs about work were significantly associated with the perception of the work environment, whereas neck and back pain were not.

Change in pain, disability and influence of fear-avoidance in a work-focused intervention on neck and back pain: a randomized controlled trial.

BACKGROUND: Neck and back pain are among the most common causes of prolonged disability, and development of interventions with effect on pain, disability and return to work is important. Reduction of fear avoidance might be one mechanism behind improvement after interventions. The aim of the present study was to evaluate changes in pain and disability at the 12-month follow-up of patients with neck and back pain treated with a work-focused intervention compared to patients treated with standard interventions, and the influence of improvement fear avoidance beliefs during the interventions on pain, disability and return to work at 12-month follow-up. METHODS: 413 employed patients with back or neck pain referred to secondary care, and sick-listed between 4 weeks and 12 months, were randomized to a work-focused rehabilitation or control interventions. Follow-up was conducted 4 and 12 months after inclusion. The groups were compared (independent sample t-test) regarding differences in disability scores (Oswestry disability index/neck disability index) and pain (numeric rating scale) from baseline to 12-month follow-up. Changes in fear avoidance beliefs (FABQ) from baseline to 4 month follow-up were calculated, and the association between this change and return to work, pain and disability at 12 months were tested in stepwise multiple logistic regression models. RESULTS: Pain and, disability scores decreased to in both the work-focused and control intervention to 12-month follow-up, and there were no significant differences between the groups. FABQ decreased similarly in both groups to 4 month follow-up. The logistic regression model revealed an association between a reduced FABQ work score at 4 months and return to work within one year (adjusted OR 3.60, 95% CI 1.19 to 10.88). Reduced FABQ physical activity score at 4 months was associated with decreased disability after 12 months (adjusted OR (3.65. 95% CI 1.43 to 9.28). CONCLUSIONS: Short work-focused rehabilitation had the same effect on pain and disability as control interventions. Reduction in FABQ-W score after treatment seems to be an important predictor for return to work in both groups. TRIAL REGISTRATION: Clinicaltrials.gov NCT00840697.

Pain and disability do not influence psychological and social factors at work among sick-listed patients with neck and back pain.

BACKGROUND: It is unknown whether living with neck and back pain, disability, and mental disorders influences the perception of psychological and social factors at work among sick-listed patients. OBJECTIVES: The primary aim of the present study was to examine the associations between pain, disability, anxiety, depression, and perceived psychological and social factors at work among sick-listed patients with neck and back pain. METHODS: We performed a cross-sectional study of 380 sick-listed patients with neck and low-back pain who were referred to spine clinics at two Norwegian university hospitals. Ordinal regression was applied, with psychological and social factors at work as the dependent variable. RESULTS: Pain was not associated with psychological and social factors at work. Disability was associated with a minor increase in the perception of demands among women, but not men. Women with high anxiety or depression scores experienced less control over work situations and less positive challenges at work. Men with high depression scores perceived low support. CONCLUSIONS: Sick-listed patients with neck and back pain who had concurrent anxiety or depression reported increased psychological and social challenges at work. To provide suitable treatment in the clinical setting, further attention should be paid to the interaction between anxiety or depression and perceived job strain.

The effect of work-focused rehabilitation among patients with neck and back pain: a randomized controlled trial.

STUDY DESIGN: Multicenter randomized trial with patients listed as sick for 1 to 12 months due to neck or back pain and referred to secondary care. OBJECTIVE: To compare the return-to-work (RTW) rate among patients offered work-focused rehabilitation or multidisciplinary rehabilitation. SUMMARY OF BACKGROUND DATA: A growing number of studies have focused on the RTW processes associated with patients with back pain. Many studies have combined a workplace focus with multidisciplinary treatments; however, this focus has not been evaluated in Norway among patients with neck and back pain thus far. METHODS: A total of 405 patients who were referred to the spine clinics at 2 university hospitals in Norway were randomly assigned into work-focused and control intervention groups. The existing treatments at each hospital were used as the control interventions, which entailed either a comprehensive multidisciplinary intervention or a brief multidisciplinary intervention. The RTW rates and proportions were compared at 12 months. RESULTS: During the first 12 months after inclusion, 142 (70%) participants in the work-focused rehabilitation group and 152 (75%) participants in the control group returned to work. The median time to RTW was 161 days in the work-focused group and 158 days in the control group. A comparison of the work-focused and control interventions revealed a relative RTW probability (hazard ratio) of 0.94 (95% confidence interval = 0.75-1.17) after adjusting for age, sex, and education. CONCLUSION: The results suggest that a focus on the workplace in specialist care does not substantially alter the RTW rate compared with standard multidisciplinary treatments.

Fear-avoidance beliefs associated with perceived psychological and social factors at work among patients with neck and back pain: a cross-sectional multicentre study.

BACKGROUND: Neck and back pain are common and often account for absenteeism at work. Factors at work as well as fear-avoidance beliefs may influence sick-leave in these patients. The aims of this study were to assess: (1) how sick-listed patients in specialised care perceive demand, control, support, effort, reward, and overcommitment at work compared to a general reference group of workers; (2) if women and men report demand, control, support, effort, reward, and overcommitment differently; and (3) the association between psychological and social factors at work and fear-avoidance beliefs about work. METHODS: A cross-sectional multicentre study was carried out in 373 patients on sick leave due to neck and back pain. Psychosocial work factors were measured by demand, control, and support, (Nordic Questionnaire for Psychological and Social Factors at Work), and effort, reward and overcommitment (Effort Reward Imbalance Questionnaire). Fear avoidance beliefs about work were measured by the Fear-Avoidance Belief Questionnaire Work subscale (FABQ-W). RESULTS: Although the patients differed significantly from a reference working group regarding several subscales of demand, control, support, effort, reward, and overcommitment, the magnitude of these differences were small. The study population also reported significantly higher scores for 'demand for physical endurance' than the reference population, and Cohen's d = 0.55 here indicated a medium degree of difference. Female patients reported significantly higher on support, whereas male patients reported significantly higher demand for physical endurance, quantitative demand, effort, and overcommitment. Demand for physical endurance, job control, job support, high reward, and overcommitment were significantly associated with FABQ-W. CONCLUSIONS: Perceived psychological and social factors at work were strongly associated with fear-avoidance beliefs about work in sick-listed neck and back patients. The demand for physical endurance, control, support, high reward, as well as overcommittment at work outweighed pain and added to the burden of emotional distress and disability regarding fear-avoidance beliefs.