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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT00797368
Eligibility Criteria:
Inclusion/Exclusion Criteria:
* A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility according to each inclusion/exclusion criterion.
* The following inclusion criteria will be used to determine eligibility for this study:
* Primary complaint of ankle pain, status post inversion ankle sprain.
* The investigators decided to include patients with both acute and chronic ankle sprains since our previous work has shown that patients from both stage have exhibited positive benefits with manual therapy.66
* Age between 16-60 years old
* NPRS score \> 3 points (average score) over past 24 hrs.
* Does not meet criteria for needing radiographs per the Ottawa Ankle Rules
* The following exclusion criteria will be used to determine ineligibility for this study:
* Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, RA, osteoporosis, prolonged history of steroid use, severe vascular disease, etc.)
* Prior surgery to the distal tibia, fibula, ankle joint, or rearfoot region (proximal to the base of the metatarsals).
* Grade III ankle sprain (as defined by the West Point Ankle Sprain Grading System and/or tenderness along the anterior medial malleolus as described by,51 fracture, or other absolute contraindications to manual therapy.
* Insufficient English language skills to complete all questionnaires
* Inability to comply with treatment and follow-up schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT00797368
Study Brief:
Protocol Section:
NCT00797368