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 Xia, David G Wilder, Maruti R Gudavalli, James W DeVocht, Robert D Vining, Katherine A Pohlman, Gregory N Kawchuk, Cynthia R Long, Christine M Goertz, Ting Xia, David G Wilder, Maruti R Gudavalli, James W DeVocht, Robert D Vining, Katherine A Pohlman, Gregory N Kawchuk, Cynthia R Long, Christine M Goertz

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.

Figures

Figure 1
Figure 1
Illustration of spinal stiffness assessment tests. Skin marks over bony landmarks of the T11-L5 spinous processes and posterior superior iliac spine (A), palpatory stiffness assessment (B), stiffness assessment with a hand-held device (C); and stiffness assessment with an automated device (D).
Figure 2
Figure 2
Illustration of EMG electrode placement (A) and example EMG and motion signals (B). Root-mean-square (RMS) EMG data and motion data are scaled according to the maximum of RMS EMG data (B). B contains 3 cycles of flexion (B1), holding in position while fully flexed (B2), and extension (B3).
Figure 3
Figure 3
Self-reported record for high velocity, low amplitude spinal manipulation. Level: the segment over which the manual contact occurs (L1-5, sacrum, and sacroiliac joint); Side Up: side of body contacted by clinician providing trunk twist motion direction; Contact Point: manual contact of the thrusting hand; SP: spinous process; MP: mammillary process; DW: interspinous space 1 cm lateral to spinous processes; PSIS: posterior superior iliac spine; Ischial Tubes: Ischial tuberosity; Fossa: midpoint between ischial tuberosity and PSIS; Base: Medial aspect of the superior sacrum; Apex: inferior sacrum; Ala: sacral ala or lateral superior sacrum; Direction of thrust: direction of thrust applied by the thrusting hand; A: anterior; S: superior; I: inferior; M: medial; L: lateral.
Figure 4
Figure 4
Illustration of segmental load assessment during side-lying high-velocity spinal manipulation.
Figure 5
Figure 5
Putative effects of low back pain (A) and spinal manipulation (B).

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Pre-publication history
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