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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT00567333
Eligibility Criteria:
Inclusion Criteria:
* Mechanical LBP classified as 1, 2, 3, or 4 using Quebec Task Force (QTF) classification.70 (This includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs).
* LBP localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds.
* Pain level \> 3 on 0 to 10 scale
* Current LBP episode \> 6 weeks duration
* 18 years of age and older
* Stable prescription medication plan (No changes in prescription medications that affect musculoskeletal pain in the previous month.)
Exclusion Criteria:
* Ongoing treatment for LBP by other non-study providers
* Progressive neurological deficits or cauda equina syndrome
* QTF classifications 5 (spinal instability or fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
* QTF 7 (Spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
* Uncontrolled hypertension or metabolic disease
* Blood clotting disorders
* Severe osteoporosis
* Inflammatory or destructive tissue changes of the spine
* Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of LBP patients which generally have a poorer prognosis.
* Pregnant or nursing women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00567333
Study Brief:
Protocol Section:
NCT00567333