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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00415220
Eligibility Criteria:
Inclusion Criteria:
* Consecutive patients presenting through elective referral by primary care physicians to one of the three participating spinal neurosurgeons (SC, SJD, RJH) between December 2000 and May 2004 were screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3/4, L4/5 or L5/S1. Detailed surgical histories and physical examinations were performed on each referred patient by the consulting neurosurgeon and correlated with evidence of appropriate root compression on MR imaging. Patients who had failed at least 3 months of non-operative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy and / or acupuncture, and who were felt appropriate for microdiscectomy by the neurosurgeon were asked to consider study participation.
Exclusion Criteria:
* Radicular symptoms \< 3 months duration
* Major neurological deficits such as:
* Cauda equina syndrome
* Rapidly progressing neurological symptoms (e.g. foot drop)
* Substance abuse
* Hospitalization for intravenous or intramuscular narcotics
* Systemic or visceral disease (e.g. auto-immune diseases, major system failure)
* Hemorrhagic disorders, anticoagulation therapy
* Previous surgery at symptomatic level
* Concurrent chiropractic care at time of enrollment
* Prolonged use of systemic corticosteroids
* Osteopenia/Osteoporosis
* Spondylolisthesis grade III or IV
* Unable to read or speak English
* Age \< 18
* Pregnancy
* Dementia or other cognitive impairment
* Unavailable for follow-up (geographic barriers)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00415220
Study Brief:
Protocol Section:
NCT00415220