NCT02613455

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

October 28, 2015

Last Update Submit

November 23, 2015

Conditions

Lateral EpicondylitisTennis Elbow

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Grip Strength

    6 months

Study Arms (2)

Kenalog (triamcinolone )

ACTIVE COMPARATOR

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)Drug: lidocaine 1% (lidocaine HCl 20mg)

extracorporeal shock wave therapy

ACTIVE COMPARATOR

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

Interventions

extracorporeal shock wave therapyPROCEDURE

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.

Also known as: ESWT
extracorporeal shock wave therapy
Kenalog (triamcinolone)DRUG

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.

Also known as: Steriod, Corticosteroid
Kenalog (triamcinolone )
lidocaine 1% (lidocaine HCl 20mg)DRUG

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.

Also known as: lidocaine
Kenalog (triamcinolone )

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Ceneter

Bethesda, Maryland, 20889, United States

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave TherapyTriamcinolone AcetonideTriamcinoloneAdrenal Cortex HormonesLidocaine

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Scott M Tintle, MD

    WRNMMC Orthopaedics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott M Tintle, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 24, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

US(1)