Back to resultsTrial for Treating Painful Degenerative Disc Disease
Primary Purpose
Degenerative Disc Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)
Sham procedure
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
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
Sites / Locations
- Centeno-Schultz ClinicRecruiting
- Centeno-Schultz ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Platelet treatment
Sham procedure
Arm Description
A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).
A series of two sham procedures spaced 4 weeks apart.
Outcomes
Primary Outcome Measures
Numeric Pain Scale (NPS)
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
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
Mean modified SANE scores
Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved
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
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
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.
Incidence rate of adverse events
Incidence of adverse events after treatment
Incidence rate of surgical/other treatment interventions
Incidence of surgical/other treatment interventions after treatment
Pain medications
Changes in medications from pre to post treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05287867
Brief Title
Trial for Treating Painful Degenerative Disc Disease
Official Title
A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regenexx, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Single-blind
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet treatment
Arm Type
Experimental
Arm Description
A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
A series of two sham procedures spaced 4 weeks apart.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham procedure
Intervention Description
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 Measure Information:
Title
Numeric Pain Scale (NPS)
Description
Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain
Time Frame
3-months after 2nd treatment
Title
Modified Single Assessment Numerical Evaluation (SANE) scores
Description
Difference in modified Single Assessment Numerical Evaluation score group differences; scores range from 0-100 where 0=no improvement and 100=100% improved
Time Frame
3-months after 2nd treatment
Secondary Outcome Measure Information:
Title
Mean modified SANE scores
Description
Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved
Time Frame
1-month, 3-months, 6 months, 12 months
Title
Numeric Pain Scale (NPS)
Description
Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain
Time Frame
Baseline, 1-month, 3-months, 6 months, 12 months
Title
Functional Rating Index (FRI)
Description
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
Time Frame
Baseline, 1-month, 3-months, 6 months, 12 months
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
Baseline, 1-month, 3-months, 6 months, 12 months
Title
Incidence rate of adverse events
Description
Incidence of adverse events after treatment
Time Frame
1 month, 3 months, 6 months and 12 months
Title
Incidence rate of surgical/other treatment interventions
Description
Incidence of surgical/other treatment interventions after treatment
Time Frame
1 month, 3 months , 6 months and 12 months
Title
Pain medications
Description
Changes in medications from pre to post treatment
Time Frame
1 month, 3 months, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehren Dodson, PhD
Phone
7202877199
Email
edodson@regenexx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neven Steinmetz, PhD
Email
nsteinmetz@regenexx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Centeno, MD
Organizational Affiliation
Centeno-Schultz Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centeno-Schultz Clinic
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Speer, MBA
Email
espeer@centenoschultz.com
First Name & Middle Initial & Last Name & Degree
Christopher Centeno, MD
First Name & Middle Initial & Last Name & Degree
John Schultz, MD
First Name & Middle Initial & Last Name & Degree
John Pitts, MD
First Name & Middle Initial & Last Name & Degree
Jason Markle, DO
First Name & Middle Initial & Last Name & Degree
Matthew Hyzy, DO
First Name & Middle Initial & Last Name & Degree
Brandon Money, DO
Facility Name
Centeno-Schultz Clinic
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Speer
Email
espeer@centenschultz.com
First Name & Middle Initial & Last Name & Degree
Christopher Centeno, MD
First Name & Middle Initial & Last Name & Degree
John Schultz, MD
First Name & Middle Initial & Last Name & Degree
John Pitts, MD
First Name & Middle Initial & Last Name & Degree
Jason Markle, DO
First Name & Middle Initial & Last Name & Degree
Matthew Hyzy, DO
First Name & Middle Initial & Last Name & Degree
Brandon Money, DO
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20648203
Citation
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):343-55.
Results Reference
background
PubMed Identifier
30560029
Citation
Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
Results Reference
background
PubMed Identifier
22474794
Citation
Rodrigues SV, Acharya AB, Thakur SL. Platelet-rich plasma. A review. N Y State Dent J. 2012 Jan;78(1):26-30.
Results Reference
background
PubMed Identifier
17680021
Citation
Capelli C, Domenghini M, Borleri G, Bellavita P, Poma R, Carobbio A, Mico C, Rambaldi A, Golay J, Introna M. Human platelet lysate allows expansion and clinical grade production of mesenchymal stromal cells from small samples of bone marrow aspirates or marrow filter washouts. Bone Marrow Transplant. 2007 Oct;40(8):785-91. doi: 10.1038/sj.bmt.1705798. Epub 2007 Aug 6.
Results Reference
background
PubMed Identifier
22023622
Citation
Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371.
Results Reference
background
PubMed Identifier
29177632
Citation
Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.
Results Reference
background
PubMed Identifier
34659923
Citation
Williams C, Jerome M, Fausel C, Dodson E, Stemper I, Centeno C. Regenerative Injection Treatments Utilizing Platelet Products and Prolotherapy for Cervical Spine Pain: A Functional Spinal Unit Approach. Cureus. 2021 Oct 8;13(10):e18608. doi: 10.7759/cureus.18608. eCollection 2021 Oct.
Results Reference
background
PubMed Identifier
23334400
Citation
Phillips FM, Slosar PJ, Youssef JA, Andersson G, Papatheofanis F. Lumbar spine fusion for chronic low back pain due to degenerative disc disease: a systematic review. Spine (Phila Pa 1976). 2013 Apr 1;38(7):E409-22. doi: 10.1097/BRS.0b013e3182877f11.
Results Reference
background
Learn more about this trial
Trial for Treating Painful Degenerative Disc Disease
We'll reach out to this number within 24 hrs