Clinical trial NCT03940313: Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
Official title: Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Low Back Pain
Myofascial Pain
Keywords: Chronic Low Back Pain
Myofascial pain
Tensegrity
Prolotherapy
Platelet-Rich Plasma
Lead sponsor: ProloAustin
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic lower back pain that meet inclusion and exclusion criteria.

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.

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

Primary outcomes:
measure: Pain Scale
timeFrame: At baseline and at 3 month follow-up.
measure: MSK Ultrasound
timeFrame: At baseline and at 3 month follow-up
Secondary outcomes:
measure: Medications
timeFrame: At baseline and at 3 month follow-up
Other outcomes:
Locations:
city: Austin
country: United States
facility: ProloAustin
state: Texas
Study officials:
affiliation: ProloAustin
name: Bradley Fullerton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.