Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis

Study Overview
=================
Brief Summary
-----------------
Objectives: The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo. Patients and Methods: Fifty one patients diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound, pulsed ultrasound and placebo groups by using closed envelop method. First group received continuous ultrasound treatment. Second group received pulsed ultrasound treatment in proportion as. Third group received of placebo treatment. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).

Detailed Description
-----------------
The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo. Fifty one patients (33 women, 18 men) diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound (n=17), pulsed ultrasound (n=17) and placebo (n=17) groups by using closed envelop method. First group received 10 sessions of 1 W/cm2 and 1,5 MHz continuous ultrasound treatment. Second group received 10 sessions of 1 W/cm2 and 1,5 MHz pulsed ultrasound treatment in proportion as 1:4. Third group received 10 sessions of placebo treatment with the same device seemed to be working but without delivering any output. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).

Official Title
-----------------
Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Patients With Lateral Epicondylitis : a Double Blind, Randomized and Placebo-controlled Study

Conditions
-----------------
Lateral Epicondylitis

Intervention / Treatment
-----------------
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18-70 years pain on the lateral side of the elbow for less than six months tenderness over the lateral epicondyle pain during extension of wrist and fingers Exclusion Criteria: upper extremity and neck disorders other elbow pathologies presence of tendon rupture usage of non-steroidal anti inflammatory drugs joint limitations due to a previous radius/ulna fracture previous elbow surgery osteoporosis, malignancy, hemophilia, neurologic deficit(s) in the ipsilateral upper limb cognitive disfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: continuous ultrasound<br>continuous ultrasound were applied to the patients | Device: ultrasound<br>* therapeutical ultrasound were applied to the patients<br>|
| Experimental: pulsed ultrasound<br>pulsed ultrasound were applied to the patients | Device: ultrasound<br>* therapeutical ultrasound were applied to the patients<br>|
| Experimental: placebo<br>placebo (sham) ultrasound were applied to the patients | Device: ultrasound<br>* therapeutical ultrasound were applied to the patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring the thickness of common extensor tendon by ultrasound imaging. | the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study | 2nd week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale |  | 6th week | 
| Duruoz's hand index |  | 6th week | 
| Patient-Rated Tennis Elbow Evaluation (PRTEE) scales |  | 6th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lateral epicondylitis, therapeutical ultrasound