Shoulder PainPhase 2NCT01544283
Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome
A Phase 2 study testing Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch and Triamcinolone Acetonide in people with Shoulder Pain, run by Injury Care Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Injury Care Medical Center
Boise, Idaho, 83713
Jill L Heinz, MHS, CCRP, 208-939-2100 ext. 4, jill@injurycaremedical.com
Richard D Radnovich, DO
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch, Triamcinolone Acetonide
- Keywords
- Shoulder Pain, Shoulder Impingement Syndrome
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patchDrug
Also called lidocaine 70 mg/tetracaine 70mg 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 AcetonideDrug
Also called Kenalog, Trivaris
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.
| Study group | Role | What they receive |
|---|---|---|
| Patch | Experimental | 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. Receives: Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch |
| Subacromial Injection | Active comparator | A single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Average pain and worst pain over past 24 hours will be measured.
Measured: 6 weeks
Secondary outcomes (4)
Patient Global Assessment of Treatment Satisfaction
Measured: 6 weeks
Patient Global Impression of Change
Measured: 6 weeks
Pain Interference
Pain interference as it relates to general activity, normal work, and sleep will be measured at each visit.
Measured: 6 weeks
Patch Site Evaluation for Erythema
site patch is applied will be assessed for erythema and patch site reactions
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Injury Care Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nuvo Research Inc.
- Responsible party
- Sponsor
- Investigators
- Richard D Radnovich, DO, Principal investigator, Injury Care Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544283
- Sponsor's protocol ID
- NS001
- Status last verified
- Mar 2012
- First submitted
- 23 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heated Lidocaine Patch Compared to Subacromial Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome, A Pilot
- ClinicalTrials.gov ID
- NCT01544283
- Acronym / sponsor ID
- NS001
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, Shoulder Impingement Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Injury Care Medical CenterUniversity, hospital or other
- Collaborators
- Nuvo Research Inc.
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patch | Experimental | Drug: Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patchPatch 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. |
| Subacromial Injection | Active comparator | Drug: Triamcinolone AcetonideA single injection will be administered into the subacromial space utilizing triamcinolone acetonide at the baseline visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patchAlso: lidocaine 70 mg/tetracaine 70mg topical patchSynera 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. | Drug | Patch |
| Triamcinolone AcetonideAlso: Kenalog, TrivarisTriamcinolone 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. | Drug | Subacromial Injection |
Primary outcome
Pain Intensity
Time frame: 6 weeks
Average pain and worst pain over past 24 hours will be measured.
4 secondary outcomes
Patient Global Assessment of Treatment Satisfaction
Time frame: 6 weeks
Patient Global Impression of Change
Time frame: 6 weeks
Pain Interference
Time frame: 6 weeks
Patch Site Evaluation for Erythema
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Radnovich, DO principal investigator
Injury Care Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch and Triamcinolone Acetonide in people with Shoulder Pain, run by Injury Care Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill L Heinz, MHS, CCRP ((208) 939-2100 ext. 4, jill@injurycaremedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.