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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07317518
Eligibility Criteria:
Inclusion Criteria:
* Age: Be between 18 and 65 years old.
* Volunteer status: Be willing to participate in the study and sign an informed consent form.
* Diagnosis: Have been diagnosed by a physician with nonspecific mechanical chronic low back pain. This diagnosis is defined as follows:
* A pain episode lasting longer than 6 weeks or
* A history of recurrent low back pain (episodes lasting longer than 24 hours with at least one pain-free period of one month before/after the episode).
* Localization: Pain localized between the lowest rib and the gluteal folds.
Exclusion Criteria:
* Specific Spinal Pathologies: The presence of a specific cause for back pain (e.g., structural abnormalities such as herniation, stenosis, spondylolisthesis).
* History of Major Trauma: A history of serious trauma to the back region.
* Systemic Diseases: Systemic diseases that may affect the outcome, such as rheumatological diseases or diabetes.
* History of Cancer: Any cancer diagnosis or history.
* Osteoporosis: Diagnosis of bone loss.
* Inflammatory or Neurological Diseases: Diagnosis of inflammatory rheumatic diseases such as ankylosing spondylitis or a neurological disease.
* Radicular Pain: Presence of radicular pain radiating to the legs, suggesting nerve root compression.
Skin Conditions:
* Known skin sensitivity or allergy to the patches.
* Active dermatitis or pre-existing skin lesion in the patch application area.
* Recent Treatments: Having undergone a physical therapy and rehabilitation (PTR) program targeting the lumbar region or an intervention such as an injection within the last 3 months prior to the start of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07317518
Study Brief:
Protocol Section:
NCT07317518