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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00697827
Eligibility Criteria:
Inclusion Criteria:
* ≥ 50 years in age
* Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
* Zurich Claudication Questionnaire Score ≥ 2.0,
* Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
* Has completed at least 6 months conservative therapy
Exclusion Criteria:
* Axial back pain only without leg/buttock/groin pain
* Has had any prior lumbar spine surgery at any level
* Significant scoliosis, defined as Cobb angle \> 10°
* Spondylolisthesis \> Grade 1 or isthmic spondylolisthesis at affected level
* Osteoporosis
* Morbid obesity, defined as BMI \> 40 kg/m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00697827
Study Brief:
Protocol Section:
NCT00697827