Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol.

INTRODUCTION: Neck pain poses enormous individual and societal costs worldwide. Spinal manipulative therapy and Non-Steroidal Anti-Inflammatory Drug treatment are frequently used despite a lack of compelling efficacy data. This protocol describes a multicentre 4-arm, clinical placebo randomized controlled trial (RCT), investigating the efficacy of chiropractic spinal manipulative therapy (CSMT) versus sham CSMT, ibuprofen, and placebo medicine for acute neck pain. This superiority study will employ parallel groups, featuring a 1:1:1:1 allocation ratio. MATERIAL AND METHODS: We will randomize 320 participants equally into four groups: CSMT, sham CSMT, ibuprofen, or placebo medicine. CSMT groups are single-blinded, while the medicine groups are double-blinded. Data will be collected at baseline (Day 0), during treatment and post-treatment. The primary endpoint will assess the difference in mean pain intensity from Day 0 to Day 14 on a numeric rating scale 0-10; the CSMT group is compared to sham CSMT, ibuprofen, and placebo medicine groups, respectively. Secondary endpoints will assess mean pain intensity and mean duration at different time points, and adverse events, blinding success, and treatment satisfaction, including comparison between ibuprofen and placebo medicine. Power calculation is based on a mean neck pain rating of 5 at Day 0, with standard deviation of 1 in all groups. Mean pain reduction at Day 14 is expected to be 60% in the CSMT group, 40% in sham CSMT and ibuprofen groups, and 20% in the placebo medicine group. A linear mixed model will compare the mean values for groups with corresponding 95% confidence intervals. P values below 0.017 will be considered statistically significant. All analyses will be conducted blinded from group allocation. DISCUSSION: This RCT aims towards the highest research standards possible for manual-therapy RCTs owing to its two placebo arms. If CSMT and/or ibuprofen proves to be effective, it will provide evidence-based support for CSMT and/or ibuprofen for acute neck pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05374057. EU Clinical Trials Register: EudraCT number: 2021-005483-21.

Visual trajectory pattern as prognostic factors for neck pain.

BACKGROUND: A novel approach capturing both temporal variation and pain intensity of neck pain is by visual trajectory patterns. Recently, both previous and expected visual trajectory patterns were identified as stronger predictors of outcome than traditional measures of pain history and psychological distress. Our aim was to examine patient characteristics within the various previous and expected patterns, relationship between the two patterns and predictive value of a variable combining the previous and expected patterns. METHODS: Patients with neck pain (n = 932) consulting chiropractors were included. Baseline measures included pain intensity, disability, psychological variables and symptom history and expectations. Participants reported global perceived effect after 12 weeks. Analyses included descriptive statistics and logistic regression. RESULTS: Pain intensity, disability, psychological and worse outcome expectations increased from a single pain episode to severe ongoing pain of previous and expected patterns. Having a severe pain history was associated with poor prognosis, particularly if combined with negative expectations. The variable combining previous and expected patterns had a discriminative ability similar to that of other predictors AUC = 0.64 (95% CI = 0.60-0-67) versus AUC = 0.66 (95% CI = 0.62-0.70). The model with highest discriminative ability was achieved when adding the combined patterns to other predictors AUC = 0.70 (95% CI = 0.66-0.73). CONCLUSION: The study indicates that pain expectations are formed by pain history. The patients' expectations were similar to or more optimistic compared with their pain history. The prognostic ability of the model including a simplified combination of previous and expected patterns, together with a few other predictors, suggests that the trajectory patterns might have potential for clinical use. SIGNIFICANCE: The dynamic nature of neck pain can be captured by visual illustrations of trajectory patterns. We report, that trajectory patterns of pain history and future expectations to some extent are related. The patterns also reflect a difference in severity assessed by higher degree of symptoms and distress. Moreover, the visual trajectory patterns predict outcome at 12-weeks. Since the patterns are easily applicable, they might have potential as a clinical tool.

A prospective study of the relationship between musculoskeletal or psychological complaints and muscular responses to standardized cognitive and motor tasks in a working population.

The present study sought to determine the relationship between musculoskeletal or psychological complaints and muscular responses to standardized cognitive and motor tasks. The prospective study design examined (i) whether complaint severity predicts muscular responses during standardized tasks and (ii) whether the muscular responses predict changes in complaint severity over one year. Musculoskeletal and psychological complaints were recorded by monthly reports the four months preceding and 12 months succeeding a work session in the laboratory; complaint-severity indices were computed from complaint-severity scores (intensity scorexduration score). Surface electromyography (EMG) was recorded bilaterally from the upper trapezius, middle deltoid, and forearm extensor muscles in 45 post-office workers (30 women) during two identical task series. Between the series, exhausting submaximal muscle contractions (25% of peak torque) were performed. In adjusted regression models, no relations between musculoskeletal complaints the last four months and muscle activity during the task series were found. However, psychological complaints the last four months predicted higher muscle activity levels and a steeper rise in muscle activity in the muscles not engaged in motor task performance. Sleep disturbance was the strongest individual predictor of increased muscle responses. In contrast, psychological complaints the last four months predicted lower EMG levels in the task-engaged muscle during the complex-choice-reaction-time tasks. None of the muscle-activity responses to the standardized tasks predicted changes in severity of musculoskeletal or psychological complaints over the subsequent one-year period. In conclusion, psychological complaints predict different responses in task-engaged and non-involved muscles during cognitive and motor tasks. Musculoskeletal complaints did not predict responses to the tasks.