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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT04102761
Eligibility Criteria:
Inclusion Criteria:
* A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without contained protrusions
* Age greater than 18 and less than 70 years
* Maintained intervertebral disc heights of at least 50%
* Pain not generated from facet joints, sacro-iliac joints or any pathology other than discogenic origin.
* Pain is not responsive to conservative treatment measures (oral medications, epidural steroid injections, physical therapy)
* Pain persists for an extended period of time (i.e., at least 3 months)
* High intensity zone (HIZ) in annular fissure detected on T2 or STIR MRI, degenerated discs or contained disc protrusions.
* No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
* English speaking
Exclusion Criteria:
* Disc extrusions, disc sequestrations, severe spinal stenosis, or severe disc degeneration with grade 5 Pfirmann index or with Modic 3 level change.
* Patient refusal
* Presence of a known bleeding disorder
* Pregnancy
* Systemic or local infection
* Presence of an unstable medical or psychiatric condition
* Prior intradiscal procedure (ie. IDET, Nucleoplasty)
* Inaccessibility to discs such as fusion
* Non-English speaking
* Prior fusion surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04102761
Study Brief:
Protocol Section:
NCT04102761