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

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Walter Reed National Military Medical Center

Status and phase

Unknown
Phase 4

Conditions

Tennis Elbow
Lateral Epicondylitis

Treatments

Procedure: extracorporeal shock wave therapy
Drug: lidocaine 1% (lidocaine HCl 20mg)
Drug: Kenalog (triamcinolone)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02613455
405072-2

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Kenalog (triamcinolone )
Active Comparator group
Description:
Patients assigned to the corticosteroid arm will receive an intratendinous injection of 1cc Kenalog-40 (triamcinolone-40mg) + 2cc lidocaine 1% by an attending orthopaedic hand surgeon in clinic. They will be provided a home stretching regimen for lateral epicondylitis. They will be discouraged from using nonsteroidal anti-inflammatory drugs . No additional physical or occupational therapy will prescribed.
Treatment:
Drug: Kenalog (triamcinolone)
Drug: lidocaine 1% (lidocaine HCl 20mg)
extracorporeal shock wave therapy
Active Comparator group
Description:
Following clearance, patients will be booked for ESWT in the operating room either Walter Reed National Military Medical Center (WRNMMC) or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24 kilovolts, 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.
Treatment:
Procedure: extracorporeal shock wave therapy

Trial contacts and locations

1

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Central trial contact

Scott M Tintle, MD

Data sourced from clinicaltrials.gov

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