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

Tracking Information
First Submitted Date May 4, 2019
First Posted Date May 7, 2019
Last Update Posted Date May 23, 2019
Estimated Study Start Date June 11, 2019
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: May 4, 2019)
  • Pain Scale [ Time Frame: At 3 month follow-up ]
    Improved lower back pain / functionality
  • MSK Ultrasound [ Time Frame: At 3 month follow-up ]
    Less severe damage seen in musculoskeletal tissue on ultrasound
Change History
Current Secondary Outcome Measures
 (submitted: May 21, 2019)
Medications [ Time Frame: At baseline and at 3 month follow-up ]
Reduced use (dose or frequency) of pain medications
Original Secondary Outcome Measures
 (submitted: May 4, 2019)
Medications [ Time Frame: At 3 month follow-up ]
Reduced use of pain medications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
Official Title Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with chronic lower back pain that meet inclusion and exclusion criteria.
Condition
  • Musculoskeletal Pain
  • Low Back Pain
  • Myofascial Pain
Intervention Procedure: Prolotherapy
Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
Other Name: injection therapy
Study Groups/Cohorts
  • Subjects
    Participants >18 years old who meet inclusion and exclusion criteria, and have findings on physical exam and ultrasound that suggest potential benefit from prolotherapy.
    Intervention: Procedure: Prolotherapy
  • Controls
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 4, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 22, 2021
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Bradley Fullerton, MD 512-347-7246 info@proloaustin.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03940313
Other Study ID Numbers ICMS-2019-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Bradley D. Fullerton, MD, ProloAustin
Study Sponsor ProloAustin
Collaborators Not Provided
Investigators
Principal Investigator: Bradley Fullerton, MD ProloAustin
PRS Account ProloAustin
Verification Date May 2019