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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extracorporeal shock wave therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott M Tintle, MD | Contact | 301-295-4290 | Scott.M.Tintle.mil@mail.mil |
| Name | Affiliation | Role |
|---|---|---|
| Scott M Tintle, MD | WRNMMC Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Ceneter | Recruiting | Bethesda | Maryland | 20889 | United States |
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| D000305 | Adrenal Cortex Hormones |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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