CompletedNot Applicable

Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain

United States100 participantsStarted 2019-06-06

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Scale

Timeframe: At baseline and at 3 month follow-up.

MSK Ultrasound

Timeframe: At baseline and at 3 month follow-up

Trial details

NCT IDNCT03940313

SponsorProloAustin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-25

View on ClinicalTrials.gov More Musculoskeletal Pain trials