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

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

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).

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: ultrasound

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).

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: continuous ultrasound; continuous ultrasound were applied to the patients	Device: ultrasound; therapeutical ultrasound were applied to the patients
Experimental: pulsed ultrasound; pulsed ultrasound were applied to the patients	Device: ultrasound; therapeutical ultrasound were applied to the patients
Experimental: placebo; placebo (sham) ultrasound were applied to the patients	Device: ultrasound; therapeutical ultrasound were applied to the patients

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

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Study Director: Fulya Bakılan, Eskişehir City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2013
• Primary Completion (Actual): May 5, 2015
• Study Completion (Actual): November 5, 2018

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: lateral epicondylitis, therapeutical ultrasound
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: FTR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No