Thoraco-Lumbar Fascia Mobility

NCT03916705 | Completed

• 1 other identifier: TLFM
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Back Pain; Ultrasound; Fascia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Roland Morris Disability Questionnaire (RMDQ)

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale

  Baseline

• Perceived Global Low Back Pain Improvement

  12 weeks

Study Arms (1)

single study arm

OTHER

All enrolled participants will undergo ultrasound evaluation and chiropractic low back spinal manipulation treatment.

Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)

Interventions

High Velocity Low amplitude spinal manipulation (HVLA-SM) OTHER

HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.

single study arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 21 and 65 years
• LBP of ≥ 1-yr duration with at least ½ of days with pain over the prior 6-months
• Able to understand study procedures and willing to sign informed consent document
• Willing to forgo any manual therapy for LBP for the initial 4-week study period
• Willing to forgo any manual therapy for LBP other than study treatments during the 8-week treatment period
• Able to tolerate and safely receive study procedures

You may not qualify if:

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

Sponsors & Collaborators

• Palmer College of Chiropractic: lead

Study Sites (1)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

Related Publications (2)

• Vining R, Onifer SM, Twist E, Ziegler AM, Corber L, Long CR. Thoracolumbar fascia mobility and chronic low back pain: Phase 1 of a pilot and feasibility study assessing repeated measures and the influence of paraspinal muscle contraction. J Bodyw Mov Ther. 2023 Apr;34:19-27. doi: 10.1016/j.jbmt.2023.04.004. Epub 2023 Apr 6.

  PMID: 37301552 DERIVED

• 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.

  PMID: 36271428 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Vinining, DC, DHSc

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analysis will be performed by blinded personnel. As a single group trial involving a manual therapy, participant and provider blinding is not feasible.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 16, 2019
• Study Start: September 9, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)