Thoraco-Lumbar Fascia Mobility

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain

NCT02972073

Low Back Pain

COMPLETED NA

Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants

NCT03483714

Back Pain

COMPLETED

The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain

NCT04507074

Low Back Pain Obesity

COMPLETED NA

Clinical Study on the Use of Massage to Reconstruct the Function of Lumbar Stabilizer Muscles and Improve the "Muscle and Bone Imbalance" of Lumbar Disc Herniation

NCT06946979

Lumbar Disc Herniation

NOT_YET_RECRUITING NA

Predicting Patients' Response to Spinal Manipulation

NCT00285649

Low Back Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Data analysis will be performed by blinded personnel. As a single group trial involving a manual therapy, participant and provider blinding is not feasible.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single study arm

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

Group Type OTHER

High Velocity Low amplitude spinal manipulation (HVLA-SM)

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Velocity Low amplitude spinal manipulation (HVLA-SM)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes