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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Injury Care Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
Injury Care Medical Center
ClinicalTrials.gov Identifier:
NCT01544283
First received: February 23, 2012
Last updated: March 5, 2012
Last verified: March 2012
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 Impingement Syndrome
Shoulder Pain
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 28, 2014