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

Terminated 8 enrolled Regenexx, LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2019-05-02
Primary completion: 2022-06-29
Completion: 2022-06-29

Publications

Background Aure OF, Nilsen JH, Vasseljen O. Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. Spine (Phila Pa 1976). 2003 Mar 15;28(6):525-31; discussion 531-2. doi: 10.1097/01.BRS.0000049921.04200.A6.
Background Suni J, Rinne M, Natri A, Statistisian MP, Parkkari J, Alaranta H. Control of the lumbar neutral zone decreases low back pain and improves self-evaluated work ability: a 12-month randomized controlled study. Spine (Phila Pa 1976). 2006 Aug 15;31(18):E611-20. doi: 10.1097/01.brs.0000231701.76452.05.
Background Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.
Background Hodges PW, James G, Blomster L, Hall L, Schmid A, Shu C, Little C, Melrose J. Multifidus Muscle Changes After Back Injury Are Characterized by Structural Remodeling of Muscle, Adipose and Connective Tissue, but Not Muscle Atrophy: Molecular and Morphological Evidence. Spine (Phila Pa 1976). 2015 Jul 15;40(14):1057-71. doi: 10.1097/BRS.0000000000000972.
Background Kader DF, Wardlaw D, Smith FW. Correlation between the MRI changes in the lumbar multifidus muscles and leg pain. Clin Radiol. 2000 Feb;55(2):145-9. doi: 10.1053/crad.1999.0340.
Background Hussein M, Hussein T. Effect of autologous platelet leukocyte rich plasma injections on atrophied lumbar multifidus muscle in low back pain patients with monosegmental degenerative disc disease. SICOT J. 2016 Mar 22;2:12. doi: 10.1051/sicotj/2016002.
Background Sicari BM, Agrawal V, Siu BF, Medberry CJ, Dearth CL, Turner NJ, Badylak SF. A murine model of volumetric muscle loss and a regenerative medicine approach for tissue replacement. Tissue Eng Part A. 2012 Oct;18(19-20):1941-8. doi: 10.1089/ten.TEA.2012.0475.
Background Miroshnychenko O, Chang WT, Dragoo JL. The Use of Platelet-Rich and Platelet-Poor Plasma to Enhance Differentiation of Skeletal Myoblasts: Implications for the Use of Autologous Blood Products for Muscle Regeneration. Am J Sports Med. 2017 Mar;45(4):945-953. doi: 10.1177/0363546516677547. Epub 2016 Dec 27.
Background Gentile NE, Stearns KM, Brown EH, Rubin JP, Boninger ML, Dearth CL, Ambrosio F, Badylak SF. Targeted rehabilitation after extracellular matrix scaffold transplantation for the treatment of volumetric muscle loss. Am J Phys Med Rehabil. 2014 Nov;93(11 Suppl 3):S79-87. doi: 10.1097/PHM.0000000000000145.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Platelet Lysate	Unknown	2 ml	Other
Subject	Platelet Poor Plasma	Unknown	2.5 ml	Other
Subject	Platelet Rich Plasma	Other / unclassified	1 ml	Other
Subject	Platelet Rich Plasma	Other / unclassified	2.5 ml	Other
Background	Ropivacaine	Other / unclassified	1 ml	Other

Indications

No indication recorded.