Trial for Treating Painful Degenerative Disc Disease

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Degenerative Disc Disease

In brief

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 facts

Study ID

NCT05287867

Run by

Regenexx, LLC

People needed

42

Starts

2022-05-06

Expected to finish

2026-12-31

Last updated by the study team

2025-04-06

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Centeno-Schultz Clinic — Broomfield, Colorado, United States (enrolling)
• Centeno-Schultz Clinic — Lone Tree, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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