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Completed

NCT Number: NCT03916705

Thoraco-Lumbar Fascia Mobility

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Velocity Low amplitude spinal manipulation (HVLA-SM)

Other

HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.

Primary outcomes

  1. Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound

    Time frame: Short term change (Baseline), longer-term change (4 weeks)

    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

  2. Investigate changes in thoracolumbar fascia movement (called shear-strain) using ultrasound after high-velocity low-amplitude spinal manipulation

    Time frame: 4-weeks, 8-weeks, 12 weeks

    Changes in shear-strain measures associated with high-velocity low-amplitude spinal manipulation will be assessed at 3 separate time points.

  3. Examine differences in thoracolumbar movement (called shear-strain) using ultrasound. Measurements will be obtained in relaxed and active muscle contraction states

    Time frame: Baseline

    Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Worst, average, and current pain intensity measured on a self-reported 5-point numerical rating scale. Lower scores indicate lower pain

  2. Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    Pain interference measured on a self-reported 4-point numerical rating scale. The scale ranges from 4-20. Lower scores indicate higher pain interference.

  3. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

    A 24-item self-reported scale assessing low-back pain related disability. Scores range from 0-24 with higher scores indicating higher disability.

  4. Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale

    Time frame: Baseline

    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.

  5. Perceived Global Low Back Pain Improvement

    Time frame: 12 weeks

    A single question asking patients about their perceived improvement on a 7 point scale. Lower scores indicate greater improvement.

  6. Patient Reported Outcomes Measurement Information System (PROMIS) neuropathic pain quality scale

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Palmer College of Chiropractic

Other

Registry information

Official study title

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

Acronym: TLFM

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2019
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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