The purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). This study will compare baseline measurements, measurements after a single high velocity low amplitude spinal manipulation (HVLA-SM) and after a course of up to 16 HVLA-SM.
The investigators will conduct a single arm pilot (proof-of-concept) clinical trial. Approximately 30 participants with self-reported chronic low-back pain (LBP), defined as pain for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be enrolled. This trial will consist of two separate enrollment phases. Phase 1 consists of enrollment at baseline followed by 3 separate ultrasound measurements. Phase 1 ends after a 4-week no treatment run-in phase. Phase 2 begins twice-weekly HVLA-SM treatments to the thoracolumbar region for 8-weeks. Two ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). Pre-treatment ultrasound evaluations will be obtained at 4-weeks and 8-weeks. The primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound) at the level of the lumbar L2-L3 vertebrae bilaterally. Ultrasound measures will be obtained with a Terason t3000 system using a 12L5 linear array probe with 10 MHz setting. Because shear strain may differ between sexes, we will attempt to recruit equal numbers of male and female participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
31
HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.
Palmer Center for Chiropractic Research
Davenport, Iowa, United States
Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound
Short and longer-term changes in shear-strain will be studied by comparing between ultrasound recordings obtained at baseline and between measurements obtained at baseline and after 4-weeks
Time frame: Short term change (Baseline), longer-term change (4 weeks)
Investigate changes in thoracolumbar fascia movement (called shear-strain) using ultrasound after high-velocity low-amplitude spinal manipulation
Changes in shear-strain measures associated with high-velocity low-amplitude spinal manipulation will be assessed at 3 separate time points.
Time frame: 4-weeks, 8-weeks, 12 weeks
Examine differences in thoracolumbar movement (called shear-strain) using ultrasound. Measurements will be obtained in relaxed and active muscle contraction states
Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.
Time frame: Baseline
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity
Worst, average, and current pain intensity measured on a self-reported 5-point numerical rating scale. Lower scores indicate lower pain
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference
Pain interference measured on a self-reported 4-point numerical rating scale. The scale ranges from 4-20. Lower scores indicate higher pain interference.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Roland Morris Disability Questionnaire (RMDQ)
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A 24-item self-reported scale assessing low-back pain related disability. Scores range from 0-24 with higher scores indicating higher disability.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale
A 5-item self-reported scale used to identify persons more likely to have nociceptive pain. The scale ranges from 5-25 with higher scores indicating nociceptive pain is more likely.
Time frame: Baseline
Perceived Global Low Back Pain Improvement
A single question asking patients about their perceived improvement on a 7 point scale. Lower scores indicate greater improvement.
Time frame: 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) neuropathic pain quality scale
A 5-item self-reported scale used to identify persons more likely to have neuropathic pain. The scale ranges from 5-25 with higher scores indicating neuropathic pain is more likely.
Time frame: Baseline