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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00665132
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Chronic peripheral pain persisting for greater than or equal to 3 months diagnosed previously as a mononeuropathy of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
* Average chronic pain level greater than or equal to 5/10 \[on 0-10 numeric rating scale (NRS) (BPI#14)\], where such pain is attributed to injury, irritation, or entrapment of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
* Failure of a single prior carpal tunnel release surgery to provide relief, where such failed surgery was performed greater than or equal to study entry
* Able to tolerate stimulation (TENS)
* Temporary pain relief is achieved by local anesthetic block of the target median nerve suspected to be the source of chronic pain symptoms
* Ability to give informed consent and understand study requirements
* Ability to quantify pain using a 0-10 numeric rating scale \[A screening tool will be used to ensure that subjects can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other, with mosquito bite \< stubbed toe \< broken bone\]
* Willing and able to understand and comply with all study-related procedures during the course of the study
* Motivated to maintain an accurate diary for the study duration
Exclusion Criteria:
* Metal implants in the forearm
* Active infection
* Active or existing skin disorder or irritation which, at the physician's discretion, contraindications use of skin gel electrodes
* Allodynia
* Regular use of antiplatelet medications \[e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)\]
* Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
* Cardiac pacemaker
* Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve stimulator) or implanted pump or infusion device
* History of cardiac arrhythmia with homodynamic instability
* Untreated drug habituation or dependence
* Psychologically or medically unstable
* Uncontrolled seizures (averaging \> 2 seizures per month)
* Pregnant or plan on becoming pregnant or breastfeeding during the study period
* Currently require, or likely to require, diathermy and/or MRI during the study duration
* History of adverse reactions to local anesthetic (e.g., lidocaine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00665132
Study Brief:
Protocol Section:
NCT00665132