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Open Access Study protocol

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

Ting Xia1*, David G Wilder2, Maruti R Gudavalli1, James W DeVocht1, Robert D Vining1, Katherine A Pohlman3, Gregory N Kawchuk4, Cynthia R Long1 and Christine M Goertz1

Author Affiliations

1 Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, Davenport, Lowa IA 52803, USA

2 Department of Biomedical Engineering, University of Iowa, Lowa City, Lowa, USA

3 Department of Pediatrics, University of Alberta, Edmonton, AB, Canada

4 Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada

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BMC Complementary and Alternative Medicine 2014, 14:292  doi:10.1186/1472-6882-14-292

Published: 8 August 2014

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.

Keywords:
Low back pain; Spinal manipulation; Patient-centered outcomes; Spinal stiffness; Flexion relaxation; Spine segmental load