Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome - Full Text View

Purpose

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.

Condition	Intervention	Phase
Shoulder Pain	Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch Drug: Triamcinolone Acetonide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot

Resource links provided by NLM:

MedlinePlus related topics: Shoulder Injuries and Disorders

Drug Information available for: Triamcinolone diacetate Lidocaine hydrochloride Triamcinolone acetonide Tetracaine Triamcinolone Tetracaine hydrochloride Lidocaine Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Injury Care Medical Center:

Primary Outcome Measures:

Pain Intensity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Average pain and worst pain over past 24 hours will be measured.

Secondary Outcome Measures:

Patient Global Assessment of Treatment Satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Pain Interference [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.
Patch Site Evaluation for Erythema [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
site patch is applied will be assessed for erythema and patch site reactions

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patch 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.	Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch 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. Other Name: lidocaine 70 mg/tetracaine 70mg topical patch
Active Comparator: Subacromial Injection A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.	Drug: Triamcinolone Acetonide 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. Other Names: Kenalog Trivaris

Arms

Assigned Interventions

Experimental: Patch

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.

Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch

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.

Other Name: lidocaine 70 mg/tetracaine 70mg topical patch

Active Comparator: Subacromial Injection

A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit.

Drug: Triamcinolone Acetonide

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.

Other Names:

Kenalog
Trivaris

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544283

Contacts

Contact: Jill L Heinz, MHS, CCRP

(208) 939-2100 ext 4

jill@injurycaremedical.com

Locations

United States, Idaho
Injury Care Medical Center	Recruiting
Boise, Idaho, United States, 83713
Contact: Jill L Heinz, MHS, CCRP 208-939-2100 ext 4 jill@injurycaremedical.com
Principal Investigator: Richard D Radnovich, DO

Sponsors and Collaborators

Injury Care Medical Center

Nuvo Research Inc.

Investigators

Principal Investigator:

Richard D Radnovich, DO

Injury Care Medical Center

More Information

Additional Information:

Site Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Injury Care Medical Center
ClinicalTrials.gov Identifier:	NCT01544283 History of Changes
Other Study ID Numbers:	NS001
Study First Received:	February 23, 2012
Last Updated:	March 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Injury Care Medical Center:

Shoulder Pain
Shoulder Impingement Syndrome

Additional relevant MeSH terms:

Shoulder Pain
Shoulder Impingement Syndrome
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Tetracaine
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 19, 2013