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Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain

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. Identifier: NCT03940313
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
Bradley D. Fullerton, MD, ProloAustin

Brief Summary:
This is a prospective study on chronic low back pain patients aimed at investigating how findings on a physical examination and musculoskeletal ultrasound may correlate with myofascial damage in the lower back. By comparing these findings with a control group and collecting follow up data on patients treated in the course of normal clinical practice, the investigators will be able to discern if fascial pathology contributes to chronic low back pain and if this treatment approach may provide clinical benefit to patients in the form of pain reduction and/or reduction in pain medication use.

Condition or disease Intervention/treatment
Musculoskeletal Pain Low Back Pain Myofascial Pain Procedure: Prolotherapy

Detailed Description:

This is a prospective, observational clinical study that will be run through a private practice clinic.

New patients to the clinic that complain of chronic lower back pain will be evaluated for inclusion and exclusion criteria and appropriately recruited and enrolled into the study. The baseline evaluation will take approximately 1.5hours to complete, and will include the following: a standardized pain scale questionnaire; a baseline questionnaire that assesses duration of current pain and previous interventions; physical examination with novel techniques to assess strength; and musculoskeletal ultrasound in the lower back.

Specific physical examination techniques will assess strength of the subject on both prone straight leg raise as well as hip external rotation. Then, the investigators will test how adding myofascial tension along the lower back may affect these results. Musculoskeletal ultrasound will examine specifically the aponeurosis of the erector spinae and the posterior layer of the thoracolumbar fascia at T11, T12, and L1. These areas will be graded on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue.

Participants who have myofascial damage identified on ultrasound and are scheduled for injection treatment as part of normal clinical care will have a diagnostic injection of prolotherapy (0.3% lidocaine + 15% dextrose) in those areas as the first step of the procedure. Pre and post injection muscle testing will be performed. The treatment session then will be completed per normal clinical care; this may include injection at other locations and injection of autologous platelet-rich plasma. Routine follow-up will be scheduled at 3 months.

At 3 months, the follow-up visit will include the following: the same pain scale questionnaire; a follow-up questionnaire to assess changes in function and pain medication; physical examination as before; musculoskeletal ultrasound in the specified areas.

New patients to the clinic who do not have chronic low back pain >12 weeks will be asked to participate as controls, and will undergo a similar questionnaire, and the same physical examination and musculoskeletal ultrasound.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
Estimated Study Start Date : June 11, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : March 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
Participants >18 years old who meet inclusion and exclusion criteria, and have findings on physical exam and ultrasound that suggest potential benefit from prolotherapy.
Procedure: Prolotherapy
Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
Other Name: injection therapy

Participants >or =18 years old who do not complain of lower back pain, but consent to have physical examination testing and musculoskeletal ultrasound of the lower back to evaluate these areas.

Primary Outcome Measures :
  1. Pain Scale [ Time Frame: At baseline and at 3 month follow-up. ]

    Improved lower back pain / functionality.

    Pain will be discerned on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain the participant has experienced. There will be no subscales provided, and only whole numbers will be allowed to be reported.

  2. MSK Ultrasound [ Time Frame: At baseline and at 3 month follow-up ]

    Musculoskeletal ultrasound will evaluate specific areas in the lower back on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue. The scale is described as follows:

    0= No significant compressibility (well defined)

    1. Mild compressibility but no translation (heterogeneous)
    2. Moderate compressibility, mild translation (heterogeneous, poorly organized)
    3. Significant compressibility and translation (heterogeneous, poorly organized)

    The results from each of the areas evaluated will then be summed for a total composite score. All values, including the individual area score and total composite score, will be recorded. Higher scores are considered worse outcomes. The results of the ultrasound evaluation will be determined solely by the principal investigator.

Secondary Outcome Measures :
  1. Medications [ Time Frame: At baseline and at 3 month follow-up ]
    Reduced use (dose or frequency) of pain medications

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:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with chronic lower back pain that meet inclusion and exclusion criteria.

Inclusion Criteria:

  • Age > or = 18 years old
  • Chronic lower back pain > or = 12 weeks duration

Exclusion Criteria:

  • History of stroke preventing bilateral muscle strength testing
  • History of scoliosis that may affect myofascial dynamics
  • Acute radiculopathy/sciatica or pain that limits movement for physical examination
  • Unable to lie prone for physical examination

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 identifier (NCT number): NCT03940313

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Contact: Bradley Fullerton, MD 512-347-7246

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United States, Texas
ProloAustin Recruiting
Austin, Texas, United States, 78746
Contact: Bradley Fullerton, MD    512-347-7246   
Sponsors and Collaborators
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Principal Investigator: Bradley Fullerton, MD ProloAustin
Additional Information:
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Responsible Party: Bradley D. Fullerton, MD, Adjunct Assistant Professor, Texas A&M College of Medicine, ProloAustin Identifier: NCT03940313    
Other Study ID Numbers: ICMS-2019-004
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Bradley D. Fullerton, MD, ProloAustin:
Chronic Low Back Pain
Myofascial pain
Platelet-Rich Plasma
Additional relevant MeSH terms:
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Musculoskeletal Pain
Back Pain
Low Back Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases