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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00597766
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 18
* upper extremity hemiplegia due to hemorrhagic or nonhemorrhagic stroke
* ≤ 4/5 on manual muscle testing for the deltoid on the affected side if isolated movement is present
* post-stroke duration ≥ 1-mo, but \< 24-mo
* shoulder pain sustained for ≥ 1-mo
* BPI 12 ≥ 4 (pain scale)
* willing and able to report pain and other conditions throughout the 4-mo study period
* positive Neer's test
Exclusion Criteria:
* evidence of joint or overlying skin infection
* \> 2 opioid and/or nonopioid analgesic for shoulder pain (i.e., \> 2 regardless of class)
* regular intake of pain medications for any other chronic pain
* steroid injections to the shoulder in the last 6-wks
* history of pre-stroke shoulder pain
* bleeding disorder
* for those on Coumadin, INR \> 3.0
* history of allergies to lidocaine
* renal insufficiency (Creat \> 2.0)
* both history of liver disease \& abnormal liver enzyme lab results
* poorly controlled diabetes (HbA1c \> 7.0)
* medical instability
* cognitive deficits; In order to pass the cognitive exam, the participant must exhibit 3/3 registration and recall the same three objects in 30 minutes. The participant must also be able to correctly rank the following three levels of pain from highest to lowest: 1) falling from a 2-story building and breaking both ankles, 2) stubbing one's toe and 3) getting bitten by a mosquito.
* immunocompromised
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00597766
Study Brief:
Protocol Section:
NCT00597766