Corticosteroid Injection Verses High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02613455
• Other study ID #: 405072-2
• Status: Recruiting
• Phase: Phase 4
• First received: October 28, 2015
• Last updated: November 23, 2015
• Start date: July 2015

Study information

• Verified date: November 2015
• Source: Walter Reed National Military Medical Center
• Contact: Scott M Tintle, MD
• Phone: 301-295-4290
• Email: Scott.M.Tintle.mil[@]mail.mil
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Procedure:
• extracorporeal shock wave therapy
Following clearance, patients will be booked for ESWT in the operating room either WRNMMC or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24kV, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion.

Drug:
• Kenalog (triamcinolone)
patients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic.
• lidocaine 1% (lidocaine HCl 20mg)
patients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Ceneter	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	VAS is a measurement instrument to quantify pain. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.	6 months	No
Primary	Disabilities of the Arm, Shoulder and Hand (DASH)	DASH is a questionnaire to measure upper extremity symptoms and ability to perform activities. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.	6 months	No
Primary	Mayo Elbow Score	Mayo Elbow score is an elbow focused outcome score. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.	6 months	No
Primary	Veteran Rand 36 Item Health Survey (VR-36)	VR-36 is a 36 item health survey widely used in the veteran population. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.	6 months	No
Primary	Patient-Related Tennis Elbow Evaluation (PRTEE)	PRTEE is a questionnaire to measure pain and disability in patients with lateral epicondylitis. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.	6 months	No
Secondary	Grip Strength	Difference in grip strength between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy will be determined at six months following intervention.	6 months	No