Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain

NCT03940313 | Completed

• 1 other identifier: ICMS-2019-004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Low Back Pain; Myofascial Pain

Keywords

Chronic Low Back Pain; Myofascial pain; Tensegrity; Prolotherapy; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (2)

• Pain Scale

  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.

  At baseline and at 3 month follow-up.

• MSK Ultrasound

  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.

  At baseline and at 3 month follow-up

Secondary Outcomes (1)

• Medications

  At baseline and at 3 month follow-up

Study Arms (2)

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.

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.

Interventions

Prolotherapy PROCEDURE

Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue

Also known as: injection therapy

Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic lower back pain that meet inclusion and exclusion criteria.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProloAustin: lead

Study Sites (1)

ProloAustin

Austin, Texas, 78746, United States

Location

Related Publications (4)

• Dischiavi SL, Wright AA, Hegedus EJ, Bleakley CM. Biotensegrity and myofascial chains: A global approach to an integrated kinetic chain. Med Hypotheses. 2018 Jan;110:90-96. doi: 10.1016/j.mehy.2017.11.008. Epub 2017 Nov 20.

  PMID: 29317079 BACKGROUND

• Swanson RL 2nd. Biotensegrity: a unifying theory of biological architecture with applications to osteopathic practice, education, and research--a review and analysis. J Am Osteopath Assoc. 2013 Jan;113(1):34-52. doi: 10.7556/jaoa.2013.113.1.34.

  PMID: 23329804 BACKGROUND

• Fullerton BD, Reeves KD. Ultrasonography in regenerative injection (prolotherapy) using dextrose, platelet-rich plasma, and other injectants. Phys Med Rehabil Clin N Am. 2010 Aug;21(3):585-605. doi: 10.1016/j.pmr.2010.06.003.

  PMID: 20797551 BACKGROUND

• Todorov PT, Nestorova R, Batalov A. Diagnostic value of musculoskeletal ultrasound in patients with low back pain - a review of the literature. Med Ultrason. 2018 Feb 4;1(1):80-87. doi: 10.11152/mu-1245.

  PMID: 29400373 BACKGROUND

Related Links

• Clinical facility for study

MeSH Terms

Conditions

Musculoskeletal Pain; Low Back Pain

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Bradley Fullerton, MD

  ProloAustin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor, Texas A&M College of Medicine

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: June 6, 2019
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)