Actively Recruiting
Trial for Treating Painful Degenerative Disc Disease
Led by Regenexx, LLC · Updated on 2025-04-06
42
Participants Needed
2
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial for Treating Painful Degenerative Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary signature of the IRB approved Informed Consent
- Male or Female aged 25 to 65
- Degenerative disc disease affecting up to 3 levels without significant spondylolisthesis (grade 1 with ≤10% vertebral body slip)
- Chronic back and/or leg pain lasting at least 6 months that did not improve with conservative treatments like NSAIDs or physical therapy
- MRI and physical exam consistent with painful degenerative disc disease
- Failure of treatments such as epidural steroid injection, facet injection, medial branch block, radiofrequency ablation, or physical therapy
- Evidence of instability related to degenerative changes on MRI, flexion-extension x-ray, or physical deformity
- Candidate for lumbar surgery (fusion, decompression, etc.) as specified
- Independent, ambulatory, and able to comply with all post-operative evaluations and visits
You will not qualify if you...
- More than moderate central canal or foraminal stenosis
- Current smoker or quit less than 6 weeks ago
- Untreated psychological conditions contributing to chronic pain (e.g., depression, chronic pain syndrome)
- Epidural steroid injection within the past 8 weeks
- Degenerative scoliosis with a Cobb angle over 10 degrees
- Previous Regenexx lumbar procedure
- Unable to stand longer than 30 minutes
- Inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout)
- Severe neurogenic inflammation of cutaneous nerves
- Workers' compensation case
- Involved in health-related litigation
- Pregnant
- Bleeding disorders
- Taking anticoagulant or immunosuppressive medications
- Allergy or intolerance to study medication
- Chronic opioid use
- Drug abuse within 6 months prior to treatment
- Central sensitization
- Hypermobile or Ehlers-Danlos syndrome
- Any other condition that investigator believes precludes enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021
Actively Recruiting
2
Centeno-Schultz Clinic
Lone Tree, Colorado, United States, 80124
Actively Recruiting
Research Team
E
Ehren Dodson, PhD
CONTACT
N
Neven Steinmetz, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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