Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT04064866
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female at least 18 years of age.
2. Clinically suspected discogenic pain in the cervical, thoracic or lumbar spine.
3. Bring considered for discography in order to identify source of pain in the evaluation of potential surgical candidates.
4. History of neck pain or mid or low back pain for at least 3 months.
5. Failed to respond to conservative therapies that include physical therapy and analgesics.
6. Documented Pfirrmann grade changes of 7 or less at each treatment level as represented by an MRI no more than 12 months old (extravasation not excluded).
Exclusion Criteria:
1. Unresolved neck or back pain from a previous cervical, thoracic or lumbar surgery at any level.
2. Any contraindication for discography or surgery
3. Significant signs or symptoms of root or cord compression at treatment levels.
4. Any diagnosis of a concurrent pain disorder or other concurrent cause of disability.
5. Daily opioid requirements of greater than180 mg oral morphine equivalent
(OME) per day.
6. Current active systemic infection, or history of disc infection.
7. Untreated disabling thought or mood disorder.
8. Inability to provide informed consent including subjects in a socially compromised condition such as prisoners.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04064866
Study Brief:
Protocol Section:
NCT04064866