Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

Psychometric properties of the pain stages of change questionnaire as evaluated by Rasch analysis in patients with chronic musculoskeletal pain.

BACKGROUND: Our objective was to evaluate the measurement properties of the Pain Stages of Change Questionnaire (PSOCQ) and its four subscales Precontemplation, Contemplation, Action and Maintenance. METHODS: A total of 231 patients, median age 42 years, with chronic musculoskeletal pain responded to the 30 items in PSOCQ. Thresholds for item scores, and unidimensionality and invariance of the PSOCQ and its four subscales were evaluated by Rasch analysis, partial credit model. RESULTS: The items had disordered threshold and needed to be rescored. The 30 items in the PSOCQ did not fit the Rasch model Chi- square item trait statistics. All subscales fitted the Rasch models. The associations to pain (11 point numeric rating scale), emotional distress (Hopkins symptom check list v 25) and self-efficacy (Arthritis Self-Efficacy Scale) were highest for the Precontemplation subscale. CONCLUSION: The present analysis revealed that all four subscales in PSOCQ fitted the Rasch model. No common construct for all subscales were identified, but the Action and Maintenance subscales were closely related.

Activity-related pain in patients with chronic musculoskeletal disorders.

PURPOSE: Activity-related pain may be a barrier to rehabilitation in patients with chronic musculoskeletal disorders. This study investigated patients' reports of increased pain during activity, and the association between such pain and psychological factors and pain variables. METHOD: Questionnaires from 232 adults with chronic musculoskeletal pain measured pain intensity, spread of pain and pain duration. Pain during activity was assessed both on a 11-point Numeric Rating Scale (NRS), and operationalised as a dichotomous measure, where responders defined if they experienced pain during general activity and exercise. Psychological factors were measured by the Hopkins symptom check list 25, the Tampa Scale for Kinesiophobia and a subscale of the Arthritis Self-efficacy Scale. Multiple and logistic regression were used to analyse associations between increased pain during activity and associated variables. RESULTS: Increased pain during activity was reported by 69% of participants. Fear of movement was a significant factor for reporting increased pain during activity, both general activity and exercise also in a subsample with low psychological distress. Other significant factors were spread of pain and a low sense of self-efficacy. CONCLUSION: Patients with high fear of movement, large spread of pain and low self-efficacy were more likely to report increased pain during activity even in the absence of psychological distress.

Readiness to adopt a self-management approach to pain--are profiles of subscale scores on the Pain Stages of Change Questionnaire useful?

The study evaluated the ability of the Pain Stages of Change Questionnaire (PSOCQ) to classify subjects into specific profiles of readiness to adopt a self-management approach to pain. An analysis was made of whether the five earlier described PSOCQ-profiles Precontemplation, Contemplation, Non-contemplative Action, Participation and Ambivalent could be reproduced by two different methods, cluster analysis and visual analysis. The 184 included subjects completed the PSOCQ, the Hopkins Symptom Checklist (HSCL-25), the Tampa scale of Kinesiophobia (TSK) and five self-efficacy questions from the arthritis self-efficacy questionnaire (ASES). Profiles were drawn based on the mean scores of the four subscales in PSOCQ. All the five predefined profiles were identified visually by two coders with an interrater agreement of Kappa 0.731. A 6-cluster solution generated the four profiles Precontemplation, Contemplation, Non-contemplative Action and Participation. Discriminant function analysis (DFA) on cluster analysis classified 83.5% of cases in the same group, and DFA on visual classification 72.1% of cases. Fifty-three percent were classified in the same profile by cluster and visual analysis. The two profiles Precontemplation and Participation seem to identify distinct subgroups that differ in educational level, pain during activity and psychometric measures. Non-contemplative Action share characteristics with Precontemplation, and the Contemplation group has scores in between. In conclusion, more research on the validity of the PSOCQ is needed. Outcome studies after pain treatment programmes could focus three main states that differ on measures for concurrent validity: Profiles that can be identified as Precontemplation or Non-contemplative action, Contemplators, and subjects with Participation profiles.

The Tampa Scale of Kinesiophobia: A Rasch analysis of its properties in subjects with low back and more widespread pain.

OBJECTIVE: The aim of this study was to investigate the psychometric properties of the Norwegian version of the Tampa Scale of Kinesiophobia in patients with low back pain and in patients with more widespread pain distribution including low back pain. SUBJECTS: A total of 120 subjects, 48 with isolated low back pain and 72 with more widespread pain distribution were included. DESIGN AND METHODS: The Norwegian translation of the Tampa Scale of Kinesiophobia, Hopkins Symptom Check List 25 question version and Fear Avoidance Behaviour Questionnaire were completed. The properties of the Norwegian translation of the Tampa Scale of Kinesiophobia were explored by a Rasch analysis. RESULTS: The Tampa Scale of Kinesiophobia fitted the Rasch model and passed the independent t-test for a unidimensional scale. The response categories for some of the items needed to be collapsed from 4 to 3 levels. Only the item "It's not really safe for a person with a condition like mine to be physically active" was significantly different in men and women. CONCLUSION: The Norwegian translation of Tampa Scale of Kinesiophobia seems to reflect a unidimensional construct of kinesiophobia. The scale seemed to be quite robust across age and gender, and the response patterns to the items were similar in patients with low back pain and widespread pain distribution including low back pain.