Shoulder Pain
Conditions
Keywords
subacromial injection, rotator cuff disease, steroid injection
Brief summary
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.
Detailed description
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.
Interventions
DRUGlidocaine
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
DRUGethyl chloride
topical spray
DRUGKenalog
used with lidocaine in shoulder injection
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18 to 70 years old * Shoulder pain lasting at least 4 weeks * Inability to use arm with restriction of movement and loss of full function. * Able to understand study and provide voluntary, written informed consent
Exclusion criteria
* Less than 18 or greater than 70 years old * Contraindications of previous injections and previous shoulder surgery * Unable to understand consent form (in the opinion of the PI) * Non-English speaking individuals * Medication contradictions to lidocaine, corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Assessment | change from baseline assessment before injection at 10 minutes post injection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 9 |
| 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 | 5 |
| Total | 19 |
Baseline characteristics
| Characteristic | Total | no Topical or Subcutaneous Anesthetic | Subcutaneous Lidocaine | Topical Ethyl Chloride |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 5 Participants | 9 Participants | 5 Participants |
| baseline pain | 4.78 units on a scale STANDARD_DEVIATION 2.11 | 4.2 units on a scale STANDARD_DEVIATION 2.56 | 5.16 units on a scale STANDARD_DEVIATION 1.93 | 4.7 units on a scale STANDARD_DEVIATION 1.84 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 19 Participants | 5 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 9 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 | 0 / 5 |
Outcome results
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.
Time frame: change from baseline assessment before injection at 10 minutes post injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Topical or Subcutaneous Anesthetic | Change in Pain Assessment | 3 units on a scale | Standard Deviation 1.6 |
| Subcutaneous Lidocaine | Change in Pain Assessment | 4.21 units on a scale | Standard Deviation 2.19 |
| Topical Ethyl Chloride | Change in Pain Assessment | 5.6 units on a scale | Standard Deviation 1.88 |
p-value: <0.05ANOVA