RECRUITING

Trial for Treating Painful Degenerative Disc Disease

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-06

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05287867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ehren Dodson, PhD

CONTACT

7202877199

edodson@regenexx.com

Neven Steinmetz, PhD

CONTACT

nsteinmetz@regenexx.com

Principal Investigator

Christopher Centeno, MD

PRINCIPAL_INVESTIGATOR

Centeno-Schultz Clinic

Study Locations (Sites)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021

United States

Centeno-Schultz Clinic

Lone Tree, Colorado, 80124

United States

Collaborators and Investigators

Sponsor: Regenexx, LLC

Christopher Centeno, MD, PRINCIPAL_INVESTIGATOR, Centeno-Schultz Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-06

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-05-06

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Degenerative Disc Disease