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Lack of time to enroll due to additional responsibilities of the PI and research coordinator.
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The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.
Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. As a common source of distress, shoulder pain contributes significantly to health care costs.
Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option.
The steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no topical or subcutaneous anesthetic | Active Comparator | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine |
|
| subcutaneous lidocaine | Active Comparator | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection |
|
| topical ethyl chloride | Active Comparator | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine | Drug | used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Assessment | Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases. | change from baseline assessment before injection at 10 minutes post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A Gallo, MD | The Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | no Topical or Subcutaneous Anesthetic | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection |
| FG001 | Subcutaneous Lidocaine | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection |
| FG002 | Topical Ethyl Chloride | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Topical or Subcutaneous Anesthetic | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection |
| BG001 | Subcutaneous Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Assessment | Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases. | Posted | Mean | Standard Deviation | units on a scale | change from baseline assessment before injection at 10 minutes post injection |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | no Topical or Subcutaneous Anesthetic | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gallo, M.D. | Penn State Hershey Medical Center | 7175310003 | 289222 | rgallo@pennstatehershey.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2016 | Jun 20, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2016 | Jun 20, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D005018 | Ethyl Chloride |
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| ethyl chloride | Drug | topical spray |
|
|
| Kenalog | Drug | used with lidocaine in shoulder injection |
|
|
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection |
| BG002 | Topical Ethyl Chloride | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| baseline pain | The pain will be measured with a scale from 0 (no pain) to 10 (worst possible pain)". | Mean | Standard Deviation | units on a scale |
|
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection
lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
Kenalog: used with lidocaine in shoulder injection
| OG002 | Topical Ethyl Chloride | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Subcutaneous Lidocaine | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Topical Ethyl Chloride | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|