NCT05287867 · Regenexx, LLC
Trial for Treating Painful Degenerative Disc Disease
What this study 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.
View original scientific description
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.
Interventions
BIOLOGICAL
Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)
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.
OTHER
Sham procedure
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.
Primary outcome measures
Numeric Pain Scale (NPS)
Time frame: 3-months after 2nd treatment
Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain
Modified Single Assessment Numerical Evaluation (SANE) scores
Time frame: 3-months after 2nd treatment
Difference in modified Single Assessment Numerical Evaluation score group differences; scores range from 0-100 where 0=no improvement and 100=100% improved
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Broomfield, Colorado
- Lone Tree, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2025 · Source of record for eligibility and locations