Trial for Treating Painful Degenerative Disc Disease
- Conditions
- Degenerative Disc Disease
- Interventions
- Biological: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)Other: Sham procedure
- Registration Number
- NCT05287867
- Lead Sponsor
- Regenexx, LLC
- 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 degenerative disc disease. Randomization is 2:1, with 28 in the treatment group and 14 in the sham control group.
A pretreatment visit will occur at or before the time of enrollment; follow-up visits will occur at the clinical site at 3- and 12 months post injection. Target enrollment is 42 subjects. Patients in the control group can crossover to the treatment group after 3-month follow-up. Crossover patients then follow the treatment group follow-up timeline based on their second real treatment. Subjects will complete the study following the 1-year follow-up visit.
The primary objective of this study is to observe the improvement in subject-reported clinical outcomes from baseline to 3 months after 2nd treatment and between groups at 3 months, with continued evaluation of efficacy and durability up to 12 months. Questionnaires are completed at 1, 3, 6, and 12 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
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- Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Platelet treatment Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP). Sham procedure Sham procedure A series of two sham procedures spaced 4 weeks apart.
- Primary Outcome Measures
Name Time Method Numeric Pain Scale (NPS) 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 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
- Secondary Outcome Measures
Name Time Method Numeric Pain Scale (NPS) Baseline, 1-month, 3-months, 6 months, 12 months Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain
Functional Rating Index (FRI) Baseline, 1-month, 3-months, 6 months, 12 months Changes in FRI from pre to post treatment and between group differences at 1 and 3 months; scales 0-100% where 0%=no disability and 100%=very severe disability
Incidence rate of adverse events 1 month, 3 months, 6 months and 12 months Incidence of adverse events after treatment
Mean modified SANE scores 1-month, 3-months, 6 months, 12 months Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved
Oswestry Disability Index (ODI) Baseline, 1-month, 3-months, 6 months, 12 months Changes in ODI from pre to post and between group differences at 1 and 3 months; scales 0-100% where 0%=no disability and 100%=very disabled.
Incidence rate of surgical/other treatment interventions 1 month, 3 months , 6 months and 12 months Incidence of surgical/other treatment interventions after treatment
Pain medications 1 month, 3 months, 6 months and 12 months Changes in medications from pre to post treatment
Trial Locations
- Locations (1)
Centeno-Schultz Clinic
🇺🇸Lone Tree, Colorado, United States