Clinical trial NCT02592629: The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
Official title: The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Shoulder Pain
Keywords: subacromial injection
rotator cuff disease
steroid injection
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Assessment
timeFrame: change from baseline assessment before injection at 10 minutes post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: The Milton S. Hershey Medical Center
name: Robert A Gallo, MD
role: PRINCIPAL_INVESTIGATOR
References: