Recruiting

Corticosteroid vs. Shock Wave

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT02613455

Conditions

Lateral Epicondylitis

Tennis Elbow

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

extracorporeal shock wave therapy

Kenalog (triamcinolone)

lidocaine 1% (lidocaine HCl 20mg)

Study Details

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).

Conditions

Lateral Epicondylitis

Tennis Elbow

Study ID

NCT02613455

Start date

Jul, 2015

Status verified date

Nov, 2015

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Kenalog (triamcinolone )

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.

active comparator: extracorporeal shock wave therapy

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.

Interventions

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.

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.

Primary outcome measure

  • Visual Analog Scale (VAS) [ Time Frame: 6 months ]
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 months ]
  • Mayo Elbow Score [ Time Frame: 6 months ]
  • Veteran Rand 36 Item Health Survey (VR-36) [ Time Frame: 6 months ]
  • Patient-Related Tennis Elbow Evaluation (PRTEE) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Scott M Tintle, MD

301-295-4290Scott.M.Tintle.mil@mail.mil

Locations

Walter Reed National Military Medical Ceneter

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Scott M Tintle, MD

301-295-4290Scott.M.Tintle.mil@mail.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Nov 24, 2015

Last verified

Nov, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2015-11-24.