Clinical trial NCT01544283: Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
Official title: Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Shoulder Pain
Keywords: Shoulder Pain
Shoulder Impingement Syndrome
Lead sponsor: Injury Care Medical Center
Sponsor class: OTHER
Collaborators: name: Nuvo Research Inc.
First posted: 2012-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient Global Assessment of Treatment Satisfaction
timeFrame: 6 weeks
measure: Patient Global Impression of Change
timeFrame: 6 weeks
measure: Pain Interference
timeFrame: 6 weeks
measure: Patch Site Evaluation for Erythema
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boise
country: United States
facility: Injury Care Medical Center
state: Idaho
Study officials:
affiliation: Injury Care Medical Center
name: Richard D Radnovich, DO
role: PRINCIPAL_INVESTIGATOR
References: