Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Musculoskeletal Pain; Myofascial Pain
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78746
      • ProloAustin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue; Other Names: injection therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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); Mild compressibility but no translation (heterogeneous); Moderate compressibility, mild translation (heterogeneous, poorly organized); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medications	Reduced use (dose or frequency) of pain medications	At baseline and at 3 month follow-up

Collaborators and Investigators

• Sponsor: ProloAustin
• Investigators: Principal Investigator: Bradley Fullerton, MD, ProloAustin

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Clinical facility for study

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: May 4, 2019
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Myofascial pain; Chronic Low Back Pain; Prolotherapy; Platelet-Rich Plasma; Tensegrity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Back Pain; Low Back Pain; Musculoskeletal Pain
• Other Study ID Numbers: ICMS-2019-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No