A Trial Comparing Three Orthobiologic Therapies on Atrophied Multifidus Muscles in Patients With Low Back Pain

Stopped early · Not applicable

Conditions studied: Low Back Pain

In brief

To evaluate and compare the effectiveness of 3 different injection treatments on multifidus atrophy and lower back pain.

Key facts

Study ID

NCT03618979

Run by

Regenexx, LLC

People needed

8

Starts

2019-05-02

Expected to finish

2022-06-29

Last updated by the study team

2022-07-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary signature of the Informed Consent
• Axial low back pain for a minimum of 3 months
• Male or female ages 18-75
• Recent MRI (within last 6 months) consistent Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

You may not qualify if…

• Mild multifidus atrophy Kader grade 1
• Multifidus atrophy at more than 2 levels
• Symptomatic spinal stenosis (e.g. pseudoclaudication with moderate or severe MRI findings of stenosis)
• Radicular symptoms (e.g. lower extremity radiating numbness, tingling, paresthesia, etc)
• Fracture, previous spine surgery, neuromuscular disease of the trunk, malignancy, infection, or pregnancy
• Radiofrequency ablation within the previous 12 months
• Corticosteroid injection (epidural or facet) within the past 3 months
• Contraindications for MRI
• Condition represents a worker's compensation case
• Currently involved in a health-related litigation procedure
• Bleeding disorders
• Allergy or intolerance to study medication
• Use of chronic opioid
• Documented history of drug abuse within six months of treatment
• Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Where it is running

• Centeno-Schultz Clinic — Broomfield, Colorado, United States
• Centeno-Schultz Clinic — Lone Tree, Colorado, United States

Full record on ClinicalTrials.gov

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