Clinical trial NCT02613455: Corticosteroid Injection Verses High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
Official title: Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lateral Epicondylitis
Tennis Elbow
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2015-11-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively compare the pain and functional outcomes of patients with chronic lateral epicondylitis treated with either intratendinous corticosteroid injection or high energy extracorporeal shock wave therapy (ESWT).

Detailed description: Corticosteroid injections and high energy ESWT are standard therapies for lateral epicondylitis at Walter Reed National Military Medical Center. While corticosteroid injections have been shown to be moderately effective in the short term for the condition, a significant minority of patients remains symptomatic. Low energy ESWT has mixed results in the orthopaedic literature, but to date no study has specifically examined the effects of high energy ESWT. The investigators plan to randomize a total of 80 patients with the diagnosis of lateral epicondylitis to either corticosteroid injection or high energy ESWT, and follow them for a total of 12 months. Primary outcomes will be Disabilities of the Arm, Shoulder, and Hand (DASH) score, Patient Reported Tennis Elbow Evaluation (PRTEE) score, Mayo Elbow Score, Veterans Rand-36, and return-to-work status. Patients will be surveyed at baseline, 6 weeks, 3 months, and 6 months. All assessments will be done by an independent physician examiner who is blinded to the treatment received.

Eligibility criteria: Inclusion Criteria:

* All patients presenting to the WRNMMC orthopaedic hand surgery clinic for complaints of lateral elbow pain will be evaluated for inclusion in the study. Inclusions criteria will be:
* Clinical diagnosis of lateral epicondylitis based on primary complaint of lateral elbow pain and either (a) tenderness over the lateral epicondyle with direct palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion of the wrist
* Failure of previous trial of non-operative management of at least 4wks duration (to include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational therapy, home stretching regimen)

Exclusion Criteria:

* Age \<18yo
* Pregnant or planning to become pregnant during study period (based on verbal questioning)
* Steroid treatment (oral or injectable) within the previous 3mo
* Diagnosis of ipsilateral compressive neuropathy
* Allergy to Kenalog, lidocaine, or conductive ultrasound gel
* Diagnosis of inflammatory arthropathy or rheumatoid conditions
* Diagnosis of fibromyalgia, chronic fatigue syndrome, complex regional pain syndrome, or other chronic widespread pain syndromes

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 6 months
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 6 months
measure: Mayo Elbow Score
timeFrame: 6 months
measure: Veteran Rand 36 Item Health Survey (VR-36)
timeFrame: 6 months
measure: Patient-Related Tennis Elbow Evaluation (PRTEE)
timeFrame: 6 months
Secondary outcomes:
measure: Grip Strength
timeFrame: 6 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Ceneter
state: Maryland
Study officials:
affiliation: WRNMMC Orthopaedics
name: Scott M Tintle, MD
role: PRINCIPAL_INVESTIGATOR
References: