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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT04378959
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 90 years
* Tenderness to palpation over affected areas (using average 4 kg force for 70 kg person)
* Average pain score \>/= 4 over the week prior to enrollment
* On stable doses of analgesics for 2 weeks prior to enrollment
* Chronic mechanical neck pain \> 3 months in duration
* Boundaries are upper trapezius, mastoid processes, shoulders
Exclusion Criteria:
* Radicular pain as determined by clinical presentation
* Opioid dose in oral morphine equivalents/day \> 30
* Moderate or severe hepatic disease (will obtain blood work and exclude individuals with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the normal range.
* Previous neck surgery
* Known structural defect presumed to be the primary pain generator (e.g. severe degenerative disc or facet joint disease)
* Serious medical (e.g. unstable angina) or psychiatric (e.g. poorly controlled depression, active substance abuse) that could interfere with treatment or pain response
* Secondary gain
* Pregnancy or breastfeeding
* painDETECT score \> 18
* Known allergy to lidocaine
* Diffuse pain phenotype (e.g. fibromyalgia)
* Cervical pain greater in area than 3 patches (10 x 14 cm/patch)
* Skin defects (e.g. burns, active infection) in area(s) of application that could result in significant systemic absorption
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04378959
Study Brief:
Protocol Section:
NCT04378959