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

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ClinicalTrials.gov Identifier: NCT02613455
Recruitment Status : Unknown
Verified November 2015 by Walter Reed National Military Medical Center.
Recruitment status was:  Recruiting
First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Walter Reed National Military Medical Center

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).

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Tennis Elbow Procedure: extracorporeal shock wave therapy Drug: Kenalog (triamcinolone) Drug: lidocaine 1% (lidocaine HCl 20mg) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomize Trial Comparing Corticosteroid Injection to High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016


Arm Intervention/treatment
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.
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.
Other Name: Steriod, Corticosteroid

Drug: 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.
Other Name: lidocaine

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.
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.
Other Name: ESWT




Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 6 months ]
    VAS is a measurement instrument to quantify pain. Difference between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy at six months following intervention.

  2. Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 months ]
    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.

  3. Mayo Elbow Score [ Time Frame: 6 months ]
    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.

  4. Veteran Rand 36 Item Health Survey (VR-36) [ Time Frame: 6 months ]
    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.

  5. Patient-Related Tennis Elbow Evaluation (PRTEE) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Grip Strength [ Time Frame: 6 months ]
    Difference in grip strength between the Kenalog (triamcinolone ) group and extracorporeal shock wave therapy will be determined at six months following intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613455


Contacts
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Contact: Scott M Tintle, MD 301-295-4290 Scott.M.Tintle.mil@mail.mil

Locations
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United States, Maryland
Walter Reed National Military Medical Ceneter Recruiting
Bethesda, Maryland, United States, 20889
Contact: Scott M Tintle, MD    301-295-4290    Scott.M.Tintle.mil@mail.mil   
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
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Principal Investigator: Scott M Tintle, MD WRNMMC Orthopaedics
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Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT02613455    
Other Study ID Numbers: 405072-2
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Triamcinolone
Triamcinolone Acetonide
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors