The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
- Conditions
- Shoulder Pain
- Interventions
- Registration Number
- NCT02592629
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description no topical or subcutaneous anesthetic lidocaine Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine no topical or subcutaneous anesthetic Kenalog Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine subcutaneous lidocaine Kenalog Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection subcutaneous lidocaine 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 topical ethyl chloride lidocaine Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds topical ethyl chloride Kenalog Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds topical ethyl chloride 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
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States