Thoraco-Lumbar Fascia Mobility

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Thoraco-Lumbar Fascia Mobility in Persons With Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)


Participation Criteria
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Eligibility Criteria
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Inclusion: Adults between 21 and 65 years LBP of ≥ 1-yr duration with at least ½ of days with pain over the prior 6-months Able to understand study procedures and willing to sign informed consent document Willing to forgo any manual therapy for LBP for the initial 4-week study period Willing to forgo any manual therapy for LBP other than study treatments during the 8-week treatment period Able to tolerate and safely receive study procedures Exclusion Criteria: Chiropractic care or other manual therapy for at least 90 days prior to baseline visit Unable to visualize necessary tissue layers using musculoskeletal ultrasound Weight above 350 lbs Unable to tolerate or safely receive study procedures Need for referral Unable or unwilling to comply with study procedures Current or planned pregnancy (self-reported) within the study timeframe Any prior surgery to the thoracolumbar region Needing a proxy Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single study arm<br>All enrolled participants will undergo ultrasound evaluation and chiropractic low back spinal manipulation treatment. | Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)<br>* HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Roland Morris Disability Questionnaire (RMDQ) | A 24-item self-reported scale assessing low-back pain related disability. Scores range from 0-24 with higher scores indicating higher disability. | 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. | 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. | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain, Ultrasound, Fascia