Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.

Detailed Description
-----------------
Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups: Botox-Epic group received 20 units of Botox injection into lateral epicondyle; Botox-Tend group had 20 units of Botox injected into tender point of muscles; Steroid group had 40mg of triamcinolone injected into lateral epicondyle. The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.

Official Title
-----------------
Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study

Conditions
-----------------
Tennis Elbow

Intervention / Treatment
-----------------
* Drug: Botox-Epic
* Drug: Botox-Tend
* Drug: triamcinolone acetonide (Steroid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications, local tenderness around the lateral epicondyle, and pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors. Exclusion Criteria: local steroid injection within the past six months, coexisting elbow arthritis or arthralgia, previous trauma or surgery history over the lateral epicondyle, pregnancy or lactation, and other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox-Epic group<br>20 units of Botox injection into lateral epicondyle in Botox-Epic group | Drug: Botox-Epic<br>* injected 20 units of Botox into lateral epicondyle in Botox-Epic group<br>* Other names: onabotulinumtoxinA;|
| Experimental: Botox-Tend group<br>20 units of Botox injected into tender point of muscles in Botox-Tend group | Drug: Botox-Tend<br>* injected 20 units of Botox into tender point of muscles in Botox-Tend group<br>* Other names: onabotulinumtoxinA;|
| Active Comparator: Steroid group<br>40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group | Drug: triamcinolone acetonide (Steroid)<br>* injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group<br>* Other names: steroid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain assessed on the visual analogue scale |  | baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of grip strength by dynamometer |  | baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks | 
| Change of self-assessment by Patient-Rated Tennis Elbow Evaluation |  | baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks |