View Clinical Trial (Medical Research Study)
Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot
| City: |
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Boise |
| State: |
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Idaho |
| Zip Code: |
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83713 |
| Conditions: |
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Shoulder Pain |
| Purpose: |
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Objective:
This purpose of this pilot study is to explore the potential usefulness of Synera for the
treatment of pain associated with shoulder impingement syndrome.
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| Study Summary: |
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Subjects will receive either a subacromial injection at baseline or will be issued Synera
patches to use daily for 2 weeks and then PRN for an additional 2 weeks.
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| Criteria: |
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Inclusion Criteria:
- be at least 18 years of age.
- have pain associated with shoulder impingement syndrome in a single shoulder (minimum
2-week duration).
- have tenderness at the attachment site of the rotator cuff tendons.
- have positive Hawkin's and Neer's signs.
- report an average pain intensity score of 4 (on an 11-point scale) over the past 24
hours at the Screening/Baseline visit.
Exclusion Criteria:
- have used any topically applied pain medication on the target treatment area within
14 days preceding Study Day 1, such as non-steroidal anti-inflammatory drugs
(NSAIDs), menthol, methyl salicylate, local anesthetics (including Lidoderm®), or
steroids.
- have used any injected medication within 60 days preceding Study Day 1, such as local
anesthetic (lidocaine) or steroids.
- have a clinically significant illness within 14 days of Screening/Day 1 that, in the
opinion of the investigator, would preclude the subject from participating in the
study.
- are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
- have a history of and/or past diagnosis of severe hepatic disease.
- have participated in a clinical trial of an unapproved drug within 30 days prior to
screening.
- are pregnant, breastfeeding, or a female of childbearing potential and not practicing
an acceptable method of birth control.
- are unable or unwilling, in the opinion of the investigators, to comply with all
study procedures and cooperate fully with research staff.
- have filed a disability claim or are currently receiving disability payments for
shoulder impingement syndrome.
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| NCT ID: |
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NCT01544283 |
| Primary Contact: |
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Principal Investigator
Richard D Radnovich, DO
Injury Care Medical Center
Jill L Heinz, MHS, CCRP
Phone: (208) 939-2100 ext. 4
Email: jill@injurycaremedical.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boise, Idaho 83713
United States
Jill L Heinz, MHS, CCRP
Phone: 208-939-2100
Email: jill@injurycaremedical.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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