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

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Pain
• Intervention / Treatment: Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch; Drug: Triamcinolone Acetonide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Average pain and worst pain over past 24 hours will be measured.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Assessment of Treatment Satisfaction		6 weeks
Patient Global Impression of Change		6 weeks
Pain Interference	Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.	6 weeks
Patch Site Evaluation for Erythema	site patch is applied will be assessed for erythema and patch site reactions	6 weeks

Collaborators and Investigators

• Sponsor: Injury Care Medical Center
• Collaborators: Nuvo Research Inc.
• Investigators: Principal Investigator: Richard D Radnovich, DO, Injury Care Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): January 1, 2014
• Study Completion (ANTICIPATED): March 1, 2014

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (ESTIMATE): March 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 6, 2012
• Last Update Submitted That Met QC Criteria: March 5, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Shoulder Pain; Shoulder Impingement Syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Arthralgia; Shoulder Impingement Syndrome; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Tetracaine
• Other Study ID Numbers: NS001