Trial for Treating Painful Degenerative Disc Disease

Part of paid clinical trials in Broomfield, Colorado.

Sponsor
Regenexx, LLC
Study ID
NCT05287867
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) — BIOLOGICAL
    Approx 161-420cc autologous blood is drawn and processed into PPP, PRP, and PL, amount dependent on condition. Using sterile technique with patient sedated, US or x-ray is used to guide needles bilaterally into multifidus, specifically LM, TF, IAF. Once the lamina is reached the physician injects 2.5 cc of PPP into the multifidus muscle on one side and then repeat this on the opposite side for each level. The physician guides a needle into the supraneural transforaminal space to perform an epidural injection with 2cc of 4x PL and 1 cc of 0.5% ropivacaine. Next, a needle will then be guided into the facet joint to perform an intra-articular injection with 1cc of 14x PRP. Any tendon insertion areas will be injected using ultrasound guidance with platelet lysate dextrose. The supraspinous/interspinous, SI ligaments at the involved degenerative levels will be injected with 4x PL/12.5% dextrose/0.125% ropivacaine. If L5/S1 is involved, the iliolumbar ligaments will also be injected.
  • Sham procedure — OTHER
    Approximately 161-420 cc of autologous blood is drawn to maintain patient blinding. While lying prone, the patient's back will be exposed and prepped sterilely. Provider puts patient in conscious sedation and several needles are placed into the low back. The provider inserts needle into the facet joint and then removes. Then inserts the needle midline to ligament and removes (1 needle per level) mimicking normal needle placement, but not injecting anything.

Study Details

To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.

Key Dates

Start date
May 6, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Platelet treatment
    A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).
  • Sham Comparator: Sham procedure
    A series of two sham procedures spaced 4 weeks apart.

Primary Outcome Measure

Numeric Pain Scale (NPS) [ Time Frame: 3-months after 2nd treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Centeno-Schultz ClinicBroomfieldColorado80021
Eric Speer, MBA
[email protected]
Christopher Centeno, MD (PRINCIPAL_INVESTIGATOR)
John Schultz, MD (SUB_INVESTIGATOR)
John Pitts, MD (SUB_INVESTIGATOR)
Jason Markle, DO (SUB_INVESTIGATOR)
Matthew Hyzy, DO (SUB_INVESTIGATOR)
Brandon Money, DO (SUB_INVESTIGATOR)
Centeno-Schultz ClinicLone TreeColorado80124
Christopher Centeno, MD (PRINCIPAL_INVESTIGATOR)
John Schultz, MD (SUB_INVESTIGATOR)
John Pitts, MD (SUB_INVESTIGATOR)
Jason Markle, DO (SUB_INVESTIGATOR)
Matthew Hyzy, DO (SUB_INVESTIGATOR)
Brandon Money, DO (SUB_INVESTIGATOR)

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Centeno-Schultz Clinic· Broomfield, COCenteno-Schultz Clinic· Lone Tree, CO

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