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Thoraco-Lumbar Fascia Mobility (TLFM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916705
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: High Velocity Low amplitude spinal manipulation (HVLA-SM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation
Masking: None (Open Label)
Masking Description: Data analysis will be performed by blinded personnel. As a single group trial involving a manual therapy, participant and provider blinding is not feasible.
Primary Purpose: Basic Science
Official Title: Thoraco-Lumbar Fascia Mobility in Persons With Chronic Low Back Pain
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound [ Time Frame: 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

  2. Investigate changes in thoracolumbar fascia movement (called shear-strain) using ultrasound after high-velocity low-amplitude spinal manipulation [ Time Frame: 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.

  3. Examine differences in thoracolumbar movement (called shear-strain) using ultrasound. Measurements will be obtained in relaxed and active muscle contraction states [ Time Frame: Baseline ]
    Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.


Secondary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity [ Time Frame: 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

  2. Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference [ Time Frame: 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.

  3. Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 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.

  4. Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale [ Time Frame: 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.

  5. Perceived Global Low Back Pain Improvement [ Time Frame: 12 weeks ]
    A single question asking patients about their perceived improvement on a 7 point scale. Lower scores indicate greater improvement.

  6. Patient Reported Outcomes Measurement Information System (PROMIS) neuropathic pain quality scale [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916705


Contacts
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Contact: Study Coordinator 563-884-5153 TLFM@palmer.edu

Locations
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United States, Iowa
Palmer Center for Chiropractic Research Recruiting
Davenport, Iowa, United States, 52803
Contact: Study Coordinator    563-884-5153    TLFM@palmer.edu   
Sponsors and Collaborators
Palmer College of Chiropractic
Investigators
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Principal Investigator: Robert Vinining, DC, DHSc Palmer College of Chiropractic
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Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT03916705    
Other Study ID Numbers: TLFM
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a proof of concept study. No data will be available for sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palmer College of Chiropractic:
Back Pain
Ultrasound
Fascia
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations