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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00668434
Eligibility Criteria:
Inclusion Criteria:
* Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville site
* Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution
* Score of at least 20 on the modified Oswestry Disability Index
* Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc
* MRI study confirms a herniated disc consistent with the signs and symptoms
Exclusion Criteria:
* Onset of sciatica symptoms occurred more than 3 months before study entry
* Cauda equina syndrome
* Active cancer
* Acute spinal fracture
* Currently taking oral steroids
* Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%
* Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg
* Pregnant or breastfeeding
* Active peptic ulcer disease
* History of intolerance to steroid therapy
* Bleeding diathesis or anticoagulant therapy
* Ongoing litigation or workers compensation claim for low back pain or sciatica
* Underwent previous lumbar surgery
* Received epidural steroid injection (ESI) within the 12 months before study entry
* Unable to read or speak English
* Progressive or severe motor loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00668434
Study Brief:
Protocol Section:
NCT00668434