Trial for Treating Painful Degenerative Disc Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Biological: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)
* Other: Sham procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet treatment<br>A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP). | Biological: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)<br>* 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.<br>|
| Sham Comparator: Sham procedure<br>A series of two sham procedures spaced 4 weeks apart. | Other: Sham procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Scale (NPS) | Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain | 3-months after 2nd treatment | 
| Modified Single Assessment Numerical Evaluation (SANE) scores | Difference in modified Single Assessment Numerical Evaluation score group differences; scores range from 0-100 where 0=no improvement and 100=100% improved | 3-months after 2nd treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean modified SANE scores | Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved | 1-month, 3-months, 6 months, 12 months | 
| Numeric Pain Scale (NPS) | Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain | Baseline, 1-month, 3-months, 6 months, 12 months | 
| Functional Rating Index (FRI) | 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 | Baseline, 1-month, 3-months, 6 months, 12 months | 
| Oswestry Disability Index (ODI) | 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. | Baseline, 1-month, 3-months, 6 months, 12 months | 
| Incidence rate of adverse events | Incidence of adverse events after treatment | 1 month, 3 months, 6 months and 12 months | 
| Incidence rate of surgical/other treatment interventions | Incidence of surgical/other treatment interventions after treatment | 1 month, 3 months , 6 months and 12 months | 
| Pain medications | Changes in medications from pre to post treatment | 1 month, 3 months, 6 months and 12 months |