Thoraco-Lumbar Fascia Mobility

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)

• Registration Number: NCT03916705
• Lead Sponsor: Palmer College of Chiropractic

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-09-09
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

1. Chiropractic care or other manual therapy for at least 90 days prior to baseline visit
2. Unable to visualize necessary tissue layers using musculoskeletal ultrasound
3. Weight above 350 lbs
4. Unable to tolerate or safely receive study procedures
5. Need for referral
6. Unable or unwilling to comply with study procedures
7. Current or planned pregnancy (self-reported) within the study timeframe
8. Any prior surgery to the thoracolumbar region
9. Needing a proxy
10. Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single study arm	High Velocity Low amplitude spinal manipulation (HVLA-SM)	All enrolled participants will undergo ultrasound evaluation and chiropractic low back spinal manipulation treatment.

Primary Outcome Measures

Name	Time	Method
Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound	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	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	Baseline	Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Palmer Center for Chiropractic Research; 🇺🇸 Davenport, Iowa, United States