NCT03916705

Thoraco-Lumbar Fascia Mobility

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Palmer College of Chiropractic · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2019-04-16
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States