Lumbar Degenerative Disc Disease Study at Centeno Schultz Clinic
The Centeno Schultz Clinic in Broomfield, Colorado is seeking applicants for a new study being conducted by our Research Team. Read all of the information below before submitting your application to be considered for participation. Submit ApplicationWhat is the purpose of this study?
Our Research Team is conducting a study investigating how a series of two non-steroidal injections affect lumbar degenerative disc disease (DDD).
What will Study Participants need to do?
Participants must be able to visit the Centeno-Schultz Clinic in Broomfield, CO for evaluation, two treatment procedures spaced 1-month apart, and two follow-up visits after the 2nd procedure, at a minimum.
Participants in the study will be randomly assigned to receive either two real treatments or two sham control procedures (to mimic spine injection treatment, although nothing is injected), in a 2:1 allocation. 28 participants will be assigned to the treatment group and 14 to the sham control group.
At the 3-month follow-up visit, all participants will be notified as to which study group they had been assigned. Participants assigned to the control group can then cross over to the real treatment group at the 3-month follow-up visit.
Participant-reported outcome surveys will be completed before treatment, as well as at 1-, 3-, 6-, and 12-months.
What will selected Study Participants need?
All selected participants will need a lumbar MRI or lumbar flexion-extension x-ray to determine if they are a candidate for the lumbar degenerative disc disease (DDD) study.
What happens after you apply?
All prescreen applicants will be reviewed for candidacy by the research team. Those who meet the study eligibility criteria to move forward will be notified individually.
Who qualifies for this study?
We’ve provided inclusion and exclusion criteria in the toggles below.
Inclusion Criteria
- Skeletally mature male or female ages 25-65
- Maximum of 3 levels of 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, i.e., fusion, decompression, etc.)
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Exclusion Criteria
Candidates will be excluded if they meet ANY of the following:
- Evidence of more than moderate central canal or foraminal
- 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 last 8 weeks
- Degenerative scoliosis if cob angle over 10 degrees
- Standing intolerance (patient cannot stand longer than 30 mins)
- Inflammatory or auto-immune based joint diseases or other lower extremity pathology
- 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
Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment