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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT00521495
Eligibility Criteria:
Inclusion Criteria:
Age range (18-65 years) Both genders Hand or wrist pain with paresthesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night Symptoms present for at least 3 months No prior treatment with magnet therapy Baseline BCTQ \>2.0 on SSS subscale Meet specific EDX inclusion/ exclusion criteria listed in Table 1 (below) Willing and able to provide informed consent Ability to read English fluently
Exclusion Criteria:
Use of narcotic analgesia Corticosteroid injection into the carpal tunnel within previous 3 months Prior carpal tunnel surgery on affected side History of wrist or hand fracture on the symptomatic limb Skin rash or irritation on the wrist Participant (or bed partner) wearing a pacemaker or other electronic device Current pregnancy, less than 3 months postpartum, nursing, or planning a pregnancy Plans to move from area during the time frame of the study Inability to tolerate the baseline screening nerve conduction study Unable or unwilling to comply with the protocol Collecting workers' compensation or social-security disability benefits Involved in litigation regarding pain or disability Development of a rash or skin irritation to the tape applied to the wrist during a run-in baseline test period
Concomitant medical conditions including:
Insulin-dependent diabetes mellitus History of chronic renal failure or renal dialysis or forearm fistulae History of generalized peripheral neuropathy History of other neurologic disorders which may confuse the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor Inflammatory articular disease or tendonitis of the involved hand or wrist Other disorders known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis Cancer
Table 1. Electrodiagnostic (EDX) Inclusion and Exclusion Criteria Inclusion Criteria
* Median nerve onset sensory latency \> 3.5 ms at 13 cm
* Median-ulnar across palm latency difference ≥ 0.4 ms
* Median-radial to thumb latency difference ≥ 0.7 ms
* Median-ulnar to ring finger latency difference ≥ 0.5ms ED Exclusion Criteria
* Absent sensory nerve action potential (SNAP)
* Median nerve distal motor latency \> 6.0 ms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00521495
Study Brief:
Protocol Section:
NCT00521495