Thoraco-Lumbar Fascia Mobility (TLFM)
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|ClinicalTrials.gov Identifier: NCT03916705|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation|
|Masking:||None (Open Label)|
|Masking Description:||Data analysis will be performed by blinded personnel. As a single group trial involving a manual therapy, participant and provider blinding is not feasible.|
|Primary Purpose:||Basic Science|
|Official Title:||Thoraco-Lumbar Fascia Mobility in Persons With Chronic Low Back Pain|
|Actual Study Start Date :||September 9, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
single study arm
All enrolled participants will undergo ultrasound evaluation and chiropractic low back spinal manipulation treatment.
Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)
HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916705
|Contact: Study Coordinator||563-884-5153||TLFM@palmer.edu|
|United States, Iowa|
|Palmer Center for Chiropractic Research||Recruiting|
|Davenport, Iowa, United States, 52803|
|Contact: Study Coordinator 563-884-5153 TLFM@palmer.edu|
|Principal Investigator:||Robert Vinining, DC, DHSc||Palmer College of Chiropractic|