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Status:

RECRUITING

Trial for Treating Painful Degenerative Disc Disease

Lead Sponsor:

Regenexx, LLC

Conditions:

Degenerative Disc Disease

Eligibility:

All Genders

25-65 years

Phase:

NA

Brief Summary

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.

Detailed Description

This is a single-blind, randomized, placebo-controlled study using platelet-based treatment to the functional spinal unit .in a series of 2 treatments 4 weeks apart to treat painful lumbar degenerativ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Voluntary signature of the IRB approved Informed Consent,
  • Skeletally mature Male or Female ages 25 to 65
  • Maximum of 3 levels degenerative disc disease without significant spondylolisthesis in the area c/w the pain (grade 1 with less than or equal to 10% vertebral body)
  • Chronic back and/or leg pain having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 6 months
  • MRI and physical examination consistent with painful Degenerative Disc Disease
  • Failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy
  • Instability as seen on MRI, flexion-extension x-ray, or physical deformity as seen on MRI c/w degenerative instability (facet hypertrophy, loss of disc height, spondylolisthesis, laterolisthesis, osteophytes)
  • A lumbar surgery candidate (will need to specify which surgery, ie. fusion, decompression, etc)
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits
  • Exclusion criteria:
  • Evidence of more than moderate central canal or foraminal stenosis
  • Smoker or cessation for less than 6 weeks
  • Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor to chronic pain
  • Prior epidural steroid injection within the past 8 weeks
  • Degenerative scoliosis if cob angle over 10 degrees
  • Undergone previous Regenexx lumbar procedure
  • Standing intolerance (patient cannot stand longer than 30 minutes)
  • Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
  • Severe neurogenic inflammation of the cutaneous nerves
  • Condition represents a worker's compensation case
  • Currently involved in a health-related litigation procedure
  • Is pregnant
  • Bleeding disorders
  • Currently taking anticoagulant or immunosuppressive medication
  • Allergy or intolerance to study medication
  • Use of chronic opioid
  • Documented history of drug abuse within six months of treatment
  • Central sensitization
  • Hypermobile or EDS
  • 19\) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Exclusion

    Key Trial Info

    Start Date :

    May 6 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2026

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT05287867

    Start Date

    May 6 2022

    End Date

    December 31 2026

    Last Update

    April 6 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Centeno-Schultz Clinic

    Broomfield, Colorado, United States, 80021

    2

    Centeno-Schultz Clinic

    Lone Tree, Colorado, United States, 80124