Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome

Shoulder Pain Clinical Trial

Official title:

Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01544283
• Other study ID #: NS001
• Status: Unknown status
• Phase: Phase 2
• First received: February 23, 2012
• Last updated: March 5, 2012
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2012
• Source: Injury Care Medical Center
• Contact: Jill L Heinz, MHS, CCRP
• Phone: (208) 939-2100
• Email: jill[@]injurycaremedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Injury Care Medical Center	Boise	Idaho

Sponsors (2)

Lead Sponsor	Collaborator
Injury Care Medical Center	Nuvo Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Average pain and worst pain over past 24 hours will be measured.	6 weeks
Secondary	Patient Global Assessment of Treatment Satisfaction		6 weeks
Secondary	Patient Global Impression of Change		6 weeks
Secondary	Pain Interference	Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.	6 weeks
Secondary	Patch Site Evaluation for Erythema	site patch is applied will be assessed for erythema and patch site reactions	6 weeks

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