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:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT03888235
Eligibility Criteria:
Inclusion Criteria:
* Age 19 to 90
* Participants present with pain in their low back (below the waist) or their buttocks.
* Able to attend all 3 study visits at the participating physician's office.
* Able to attend at least the first two visits with someone willing to assist them in assessing their back and help them with the necessary exercise if need be.
* Willing to perform the corrective exercise and or wear the sacroiliac stabilization belt at home as needed
* Their posterior superior iliac spines (PSISs) are not level on initial examination.
* The long dorsal sacroiliac ligament below at least one of the (PSISs) is tender to palpation on initial examination.
Exclusion Criteria:
* Pain experienced is lumbar in origin
* Pain secondary to hip or other pathology
* PSISs are level at initial examination
* No tenderness to pressure under the PSISs
* Severe pain elsewhere in the body, making the assessment of back pain difficult.
* Presence of ankylosing spondylitis (seen on x-ray, pain worse at night, relieved by exercise, abnormal C reactive protein (CRP) or erythrocyte sedimentation rate (ESR)
* Obvious leg length discrepancy (\> 1 ½ cm) when measured umbilicus to medial malleolus.
* Location of PSISs cannot be assessed accurately due to back mice or obesity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
90 Years
Study:
NCT03888235
Study Brief:
Protocol Section:
NCT03888235