Back to resultsPain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
Primary Purpose
Shoulder Pain
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch
Triamcinolone Acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, Shoulder Impingement Syndrome
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.
Sites / Locations
- Injury Care Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patch
Subacromial Injection
Arm Description
Patch 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.
A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.
Outcomes
Primary Outcome Measures
Pain Intensity
Average pain and worst pain over past 24 hours will be measured.
Secondary Outcome Measures
Patient Global Assessment of Treatment Satisfaction
Patient Global Impression of Change
Pain Interference
Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.
Patch Site Evaluation for Erythema
site patch is applied will be assessed for erythema and patch site reactions
Full Information
NCT ID
NCT01544283
First Posted
February 23, 2012
Last Updated
March 5, 2012
Sponsor
Injury Care Medical Center
Collaborators
Nuvo Research Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01544283
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Injury Care Medical Center
Collaborators
Nuvo Research Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder Pain, Shoulder Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patch
Arm Type
Experimental
Arm Description
Patch 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.
Arm Title
Subacromial Injection
Arm Type
Active Comparator
Arm Description
A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.
Intervention Type
Drug
Intervention Name(s)
Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch
Other Intervention Name(s)
lidocaine 70 mg/tetracaine 70mg topical patch
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenalog, Trivaris
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Average pain and worst pain over past 24 hours will be measured.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Patient Global Assessment of Treatment Satisfaction
Time Frame
6 weeks
Title
Patient Global Impression of Change
Time Frame
6 weeks
Title
Pain Interference
Description
Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.
Time Frame
6 weeks
Title
Patch Site Evaluation for Erythema
Description
site patch is applied will be assessed for erythema and patch site reactions
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill L Heinz, MHS, CCRP
Phone
(208) 939-2100
Ext
4
Email
jill@injurycaremedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Radnovich, DO
Organizational Affiliation
Injury Care Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Injury Care Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill L Heinz, MHS, CCRP
Phone
208-939-2100
Ext
4
Email
jill@injurycaremedical.com
First Name & Middle Initial & Last Name & Degree
Richard D Radnovich, DO
12. IPD Sharing Statement
Learn more about this trial
Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
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