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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT05604066
Eligibility Criteria:
Healthy Volunteer Inclusion Criteria:
* Absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work
* A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale)
* Able to understand the goal of the project and give informed consent.
Healthy Volunteer Exclusion Criteria:
* Pregnancy or breastfeeding
* Any contraindication to an MRI exam
* Previous severe/acute back or low extremity injury (including fracture)
* Previous back or low extremity surgery
* Back and lower limb deformities
* Inability to provide consent.
Myofascial-Related Pain Patient Inclusion Criteria:
* A history of chronic low back or leg pain (the targeted location will be determined based on the findings in Aim 1) for at least 3 months. (Measured by patient history and physical exam)
* A palpable taut band or nodule within the skeletal muscle
* Hypersensitive tender spot within the taut band
* Recognition of current pain complaint by pressure on the tender nodule/taut band
* Painful limit to the full stretch range of motion
Myofascial-Related Pain Patient Exclusion Criteria:
* Pregnancy or breastfeeding
* Any contraindication to an MRI exam
* Previous therapy in the area to be treated within 6 months
* Previous severe back or low extremity injury (including fracture) or surgery
* Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
* Severe osteoarthritis
* Skin injuries in the area to be treated
* Inability to provide consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05604066
Study Brief:
Protocol Section:
NCT05604066