Treating Painful Degenerative Disc Disease with Platelet-Based Treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of two platelet-based treatments for painful degenerative disc disease compared to sham procedures. It is a single-blind, randomized, placebo-controlled study where participants receive treatments spaced four weeks apart. The study aims to assess improvements in clinical outcomes reported by subjects at various follow-up intervals, including 3 and 12 months post-treatment. A total of 42 subjects will be enrolled, with a 2:1 randomization between the treatment and control groups.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Christopher Centeno, MD — Centeno-Schultz Clinic
• Study coordinator: Ehren Dodson, PhD
• Email: edodson@regenexx.com
• Phone: 7202877199

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.