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Completed

NCT Number: NCT03944122

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

therapeutical ultrasound were applied to the patients

Primary outcomes

  1. measuring the thickness of common extensor tendon by ultrasound imaging.

    Time frame: 2nd week

    the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study

Secondary outcomes

  1. Visual Analog Scale

    Time frame: 6th week

  2. Duruoz's hand index

    Time frame: 6th week

  3. Patient-Rated Tennis Elbow Evaluation (PRTEE) scales

    Time frame: 6th week

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
May 9, 2019
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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