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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT03031158
Eligibility Criteria:
Inclusion Criteria:
1. Age 60-85
2. Low Back Pain for ≥ 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification.
3. Presence of at least 1 hip impairment denoted by the American College of Rheumatology as potential indicators of hip osteoarthritis: hip pain, pain on hip internal rotation or morning stiffness of the hip of \<60 minutes.
Exclusion Criteria:
1. Previous hip fracture repair or total hip replacement
2. Prominent component of radicular pain: CLBP with distal radiation below the knee
3. Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine)
4. Non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair)
5. Folstein Mini-Mental State Examination score of \<24
6. Severe visual or hearing impairment.
7. Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae (i.e. loss of sensation over saddle region, significant disturbances in bowel and bladder function).
8. Significant pain in parts of the body other than the back or acute LBP.
9. Acute, ongoing illness.
10. Inability to participate in the study for the full six months for any known reason.(i.e. moving away, extended vacation)
11. Received physical therapy for their LBP within in the last 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT03031158
Study Brief:
Protocol Section:
NCT03031158