Study protocol for patient response to spinal manipulation – a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain
Bibliographic record
Abstract
BACKGROUND: Low back pain (LBP) is a major health issue due to its high prevalence rate and socioeconomic cost. While spinal manipulation (SM) is recommended for LBP treatment by recently published clinical guidelines, the underlying therapeutic mechanisms remain unclear. Spinal stiffness is routinely examined and used in clinical decisions for SM delivery. It has also been explored as a predictor for clinical improvement. Flexion-relaxation phenomenon has been demonstrated to distinguish between LBP and healthy populations. The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes in chronic LBP patients. Additionally biomechanical characteristics of SM delivery are collected with the intention to explore the potential dose-response relationship between SM and LBP improvement. METHODS/DESIGN: This is a prospective, observational study applying side-lying, high velocity, low amplitude SM as treatment for patients with LBP over a course of 6 weeks. Approximately 80 participants will be enrolled if they present with chronic LBP of 1, 2 or 3 in Quebec Task Force Classification for spinal disorders, a Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6, and persistent LBP ≥ 2 with a maximum ≥ 4 using numerical rating scale. Patient-centered outcomes include LBP using visual analog scale, RMDQ, and PROMIS-29. Lumbar spine stiffness is assessed using palpation, a hand-held instrumented device, and an automated device. Flexion-relaxation is assessed using surface electromyography at the third level of the lumbar spine. Biomechanical characteristics of SM are assessed using a self-reported, itemized description system, as well as advanced kinetic measures that will be applied to estimate forces and moments at the lumbar segment level targeted by SM. DISCUSSION: Beside alterations in material properties of the passive components of the spine, increased neuromuscular activity may also contribute to a stiffened spine. Examining changes in both spinal stiffness and flexion-relaxation along the course of the treatment provides an opportunity to understand if the therapeutic effect of SM is associated with its action on active and/or passive components of the spine. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.026 | 0.025 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.008 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.051 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".