Is NCT06011551 recruiting in Santa Monica, CA?

Yes, NCT06011551 is currently recruiting participants at its Santa Monica, CA location. This degenerative disc disease (ddd) clinical trial is actively enrolling qualified participants.

How do I join the degenerative disc disease (ddd) clinical trial in Santa Monica?

To join this clinical trial in Santa Monica, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Santa Monica clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Degenerative Disc Disease (DDD) Clinical Trial in Santa Monica, CA

Who Can Participate

Inclusion Criteria

Male or female subjects aged 22 to 85 years, inclusive

Subjects presenting with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration

Presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by Discography

Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI

Failure to have their symptoms resolve or reduce following at least six (6) months of conservative care (as defined in the body of the protocol)

Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms

English fluency

Signed informed consent

Exclusion Criteria

History of or active systemic or local infection

Any skin disease or inadequate tissue coverage at the site of the proposed injection

Annular tear or defect that shows free contrast extravasation into the epidural space during or after Discography

Presence of more than two (2) symptomatic discs presenting with pain confirmed during Discography

Presence of extruded or sequestered disc herniation (i.e., disc extrusions or sequestrations) at the symptomatic level(s) or on adjacent levels

Presence of wide annular fissures confluent with large disc protrusions at the symptomatic level(s)

Epidural steroid injection, intradiscal injection, trigger point injection, facet or medial branch block within 60 days of enrollment

Opioid medication usage \>60 MME (morphine milligram equivalent)/day or increase in opioid use within 60 days of enrollment

Evidence of Modic type 3 changes

Subjects presenting with radicular pain greater than back pain or by history within the past six (6) months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Note: somatic referred pain is allowed

Evidence of neurogenic claudication due to spinal stenosis

Subjects with any prior back surgery on the lumbar spine

History of vertebral fractures in the lumbar spine

Evidence of severe compression of cauda equina

Evidence of spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), severe spinal canal stenosis, isthmus pathology, or scoliosis \[Cobb angle \>20 at the index level(s)\]

Subjects with arachnoiditis

Subjects who are prisoners or wards of courts

Subjects involved in active litigation including worker's compensation cases

Subjects on chronic anticoagulation due to a bleeding disorder and unable to safely stop anticoagulants, or has taken anticoagulants within three (3) days prior to procedure

Subjects with LBP of non-spinal or unknown etiology

Subjects who have a history (in the last five (5) years) of substance abuse or chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V))

Subjects who have major psychiatric disorders, such as major depression, bipolar disorder and schizophrenia, as defined by the DSM-V

If female, subjects who are pregnant or are trying to become pregnant during the course of the trial (due to risks of additional radiation exposures)

Failure to understand informed consent or inability or unwillingness to adhere to the study follow-up visit schedule or other protocol requirements

Subjects having participated in any other clinical study within the last three (3) months, or are actively participating in any other clinical study, or have planned participation in any other clinical study during the course of this trial. Note: subjects must agree they will not participate in any other clinical study during the course of this trial

Body Mass Index (BMI) \>35 kg/m2

Current smoker or nicotine and/or tobacco user

Known allergy or hypersensitivity to any of the device materials

Endocrine or metabolic disorder known to affect osteogenesis

Insulin-dependent diabetes mellitus

Inability to undergo X-ray, MRI, CT scans or other radiographic assessments, including Discography

Any comorbid medical condition which, in the best judgement of the Investigator, would make the subject unsuitable for inclusion in the study or interferes with the proper assessment of safety or effectiveness (e.g., systemic disease)

Subjects with any active malignancy or who have been previously diagnosed with a malignancy and have evidence of residual disease

Any degenerative or neurological condition that would interfere with evaluation of outcomes or that may generate an unacceptable risk of failure or postoperative complications

Chronic or acute renal and/ or hepatic impairment

Evidence of severe osteoporosis. The SCORES/MORES will be utilized to screen if a DEXA scan is indicated. If SCORES/MORES value ≥ 6; then a DEXA scan is required. Severe osteoporosis is defined as DEXA T-score \< 2.5 (spine or hip) or QCT T-score \< 80mg/cubic cm

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Santa Monica?

Yes, this clinical trial (NCT06011551) has an active research site in Santa Monica, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Degenerative Disc Disease (DDD) Treatment Options in Santa Monica, CA

If you're searching for degenerative disc disease (ddd) treatment options in Santa Monica, CA, this clinical trial (NCT06011551) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Santa Monica research site is actively enrolling participants for this clinical trial. You'll receive care from experienced degenerative disc disease (ddd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all degenerative disc disease (ddd) clinical trials near you to find additional studies recruiting in your area.

Degenerative Disc Disease (DDD) Clinical Trial in Santa Monica, CA

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About This Degenerative Disc Disease (DDD) Study in Santa Monica