Thoraco-Lumbar Fascia Mobility

Low Back Pain Clinical Trial

— TLFM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916705
• Other study ID #: TLFM
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion:

1. Adults between 21 and 65 years

2. LBP of = 1-yr duration with at least ½ of days with pain over the prior 6-months

3. Able to understand study procedures and willing to sign informed consent document

4. Willing to forgo any manual therapy for LBP for the initial 4-week study period

5. Willing to forgo any manual therapy for LBP other than study treatments during the 8-week treatment period

6. Able to tolerate and safely receive study procedures

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Palmer Center for Chiropractic Research	Davenport	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Palmer College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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