Thoraco-Lumbar Fascia Mobility (TLFM)

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: High Velocity Low amplitude spinal manipulation (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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Palmer Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Palmer College of Chiropractic
• Investigators: Principal Investigator: Robert Vinining, DC, DHSc, Palmer College of Chiropractic

Publications and helpful links

General Publications

• Vining R, Onifer SM, Twist E, Ziegler AM, Corber L, Long CR. Thoracolumbar fascia mobility and chronic low back pain: Phase 2 of a pilot and feasibility study including multimodal chiropractic care. Chiropr Man Therap. 2022 Oct 21;30(1):46. doi: 10.1186/s12998-022-00455-z.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Fascia; Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: TLFM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is a proof of concept study. No data will be available for sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No