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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944122
• Other study ID #: FTR
• Status: Completed
• Phase: N/A
• Start date: May 5, 2013
• Est. completion date: November 5, 2018

Study information

• Verified date: May 2019
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 5, 2018
• Est. primary completion date: May 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Device:
• ultrasound
therapeutical ultrasound were applied to the patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale		6th week
Secondary	Duruoz's hand index		6th week
Secondary	Patient-Rated Tennis Elbow Evaluation (PRTEE) scales		6th week