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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04923633
Eligibility Criteria:
Inclusion Criteria:
Phase I
1. Male or female between the ages of 18-75 years old.
2. Be a licensed, practicing healthcare clinician (e.g. physical therapist, massage therapist, osteopathic physician, athletic trainer, chiropractor)
3. Have at least 8 years of clinical experience in instrument-assisted soft tissue manual therapy
Phase II
1. Male and female subjects between 18-75 years old
2. Body Mass Index (BMI) ≥ 18.5 kg/m2 but \<30 kg/m2
Phase III
1. Male and female subjects, ages younger (≥18 but ≤30yo) and older (≥50 but ≤75yo)
2. Body Mass Index (BMI) ≥ 18.5 kg/m2 but \<30 kg/m2
Exclusion Criteria:
Phase I
1. \<8 years of clinical experience in instrument-assisted soft tissue manual therapy practice
2. Any known pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or any other inflammatory conditions that could interfere with the participant's ability to perform basic IASTM stroke patterns.
3. Any known cardiovascular, pulmonary, or metabolic disease that could interfere with the clinician's ability to perform basic IASTM stroke patterns.
Phase II
1. Known cardiovascular, pulmonary, or metabolic disease;
2. Current smoking or those who quit smoking within the previous 6 months;
3. Current use of anti-inflammatory or analgesics;
4. Any history of back, neck, lower extremity, or abdominal surgery or injury; or back, neck, or leg pain within the previous 6 months that impaired function;
5. Any co-morbidities that could contribute to back, neck, or leg pain (e.g., radiculopathies, rheumatoid arthritis, osteoarthritis, inflammatory conditions).
Phase III 1. The same exclusion criteria as for Phase II.
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Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04923633
Study Brief:
Protocol Section:
NCT04923633