NCT03618979

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3.2 years

First QC Date

August 2, 2018

Last Update Submit

July 6, 2022

Conditions

Low Back Pain

Keywords

regenerative medicinelow back painmultifidusplatelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • Post-treatment MRI

    Change in multifidus atrophy from baseline MRI

    6 months

Secondary Outcomes (4)

  • Single Assessment Numeric Evaluation Improvement Rating-modified

    3 months, 6 months, 12 months

  • Numeric Pain Scale

    3 months, 6 months, 12 months

  • Functional Rating Index

    3 months, 6 months, 12 months

  • Oswestry Low Back Disability Index

    3 months, 6 months, 12 months

Study Arms (3)

PPP treatment

EXPERIMENTAL

Platelet Poor Plasma (PPP) into the multifidus on each side and at each level 1 time per week for 6 weeks (series of 6 injections)

Biological: PPP treatment

PRP treatment

EXPERIMENTAL

5x concentration Platelet Rich Plasma (PRP) injected into the multifidus on each side and at each level 1 time per week for 6 weeks (series of 6 injections)

Biological: PRP treatment

PRP and PL Combo treatment

EXPERIMENTAL

5x concentration PRP injected into the multifidus, along with a facet joint injection with 14x PRP into each joint and capsule, and transforaminal epidural injection with of 3x concentrated platelet lysate (PL) and 0.5% ropivacaine on each side and at each level 1 time every 2 weeks for 6 weeks total (series of 3 injections)

Biological: PRP and PL Combo treatment

Interventions

PPP treatmentBIOLOGICAL

The day prior to or the morning of the procedure, patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of PPP depending on if there is lumbar multifidus atrophy in one or two levels. Using sterile technique and ultrasound guidance, once touching the lamina the physician will inject 2.5 cc of PPP. The physician will then repeat the procedure on the opposite side.

PPP treatment
PRP treatmentBIOLOGICAL

The day prior to or the morning of the procedure, patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of 5x PRP depending on if there is lumbar multifidus atrophy in one or two levels. Using sterile technique and ultrasound guidance, once touching the lamina the physician will inject 2.5 cc of PRP and remove the needle. The physician will then repeat the procedure on the opposite side and at the next level if indicated.

PRP treatment
PRP and PL Combo treatmentBIOLOGICAL

The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of 5x PRP and 5 or 10 cc of PL and 2 or 4 cc of 14x PRP depending on if there will be one or two levels injected. Using sterile technique, under ultrasound visualization into the lumbar multifidus and onto the lamina, the physician will inject the PRP and remove the needle. Under intermittent x-ray, epidural flow is confirmed with contrast, the physician will inject 2cc of the PL and 1cc of 0.5% ropivacaine into the epidural space. Once flow is confirmed for the epidural injection and facet with contrast, 1cc of the 14x PRP is injected into the facet joint. Procedure repeated on the opposite side and next level if indicated.

PRP and PL Combo treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Centeno-Schultz Clinic

Lone Tree, Colorado, 80124, United States

Location

Related Publications (9)

  • 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.

    PMID: 12642755BACKGROUND

  • 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.

    PMID: 16915076BACKGROUND

  • 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.

    PMID: 20193941BACKGROUND

  • 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.

    PMID: 25943090BACKGROUND

  • 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.

    PMID: 10657162BACKGROUND

  • 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.

    PMID: 27163101BACKGROUND

  • 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.

    PMID: 22906411BACKGROUND

  • 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.

    PMID: 28027451BACKGROUND

  • 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.

    PMID: 25133624BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Centeno, MD

    Centeno-Schultz Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 7, 2018

Study Start

May 2, 2019

Primary Completion

June 29, 2022

Study Completion

June 29, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)