Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMarch 6, 2012
March 1, 2012
1.8 years
February 23, 2012
March 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Intensity
Average pain and worst pain over past 24 hours will be measured.
6 weeks
Secondary Outcomes (4)
Patient Global Assessment of Treatment Satisfaction
6 weeks
Patient Global Impression of Change
6 weeks
Pain Interference
6 weeks
Patch Site Evaluation for Erythema
6 weeks
Study Arms (2)
Patch
EXPERIMENTALPatch will be applied directly to the lateral tip of the affected shoulder, at the site of maximal tenderness. Subjects will apply a single patch at home approximately every 12 hours (e.g., morning and evening patch applications) for 14 days. Subjects will remove each patch after 4 hours. Subjects will have the option of applying the Synera patch as needed for an additional 2 week period (weeks 2-4) if they feel their shoulder impingement pain is severe enough to warrant treatment. Patches will be applied every 12 hours for up to 4 hours as needed during this period.
Subacromial Injection
ACTIVE COMPARATORA single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.
Interventions
Synera consists of a thin, uniform layer of a local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetics. The drug formulation is an emulsion in which the oil phase is a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. The surface area of the entire Synera patch is approximately 50 cm2, 10 cm2 of which is active. The 40 cm2 perimeter is a medical grade adhesive. The Synera patches used in this study are the commercially available form.
Triamcinolone Acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. Each mL of the sterile aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and a 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Injury Care Medical Centerlead
- Nuvo Research Inc.collaborator
Study Sites (1)
Injury Care Medical Center
Boise, Idaho, 83713, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Radnovich, DO
Injury Care Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
March 5, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2014
Study Completion
March 1, 2014
Last Updated
March 6, 2012
Record last verified: 2012-03