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

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, therapeutical ultrasound

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    continuous ultrasound

    pulsed ultrasound

    placebo

    Arm Description

    continuous ultrasound were applied to the patients

    pulsed ultrasound were applied to the patients

    placebo (sham) ultrasound were applied to the patients

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Visual Analog Scale
    Duruoz's hand index
    Patient-Rated Tennis Elbow Evaluation (PRTEE) scales

    Full Information

    First Posted
    May 7, 2019
    Last Updated
    May 9, 2019
    Sponsor
    Eskisehir Osmangazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03944122
    Brief Title
    Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis
    Official Title
    Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Patients With Lateral Epicondylitis : a Double Blind, Randomized and Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 5, 2013 (Actual)
    Primary Completion Date
    May 5, 2015 (Actual)
    Study Completion Date
    November 5, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eskisehir Osmangazi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lateral Epicondylitis
    Keywords
    lateral epicondylitis, therapeutical ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    the patients and the physician was blind to the study
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    continuous ultrasound
    Arm Type
    Experimental
    Arm Description
    continuous ultrasound were applied to the patients
    Arm Title
    pulsed ultrasound
    Arm Type
    Experimental
    Arm Description
    pulsed ultrasound were applied to the patients
    Arm Title
    placebo
    Arm Type
    Experimental
    Arm Description
    placebo (sham) ultrasound were applied to the patients
    Intervention Type
    Device
    Intervention Name(s)
    ultrasound
    Intervention Description
    therapeutical ultrasound were applied to the patients
    Primary Outcome Measure Information:
    Title
    measuring the thickness of common extensor tendon by ultrasound imaging.
    Description
    the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study
    Time Frame
    2nd week
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale
    Time Frame
    6th week
    Title
    Duruoz's hand index
    Time Frame
    6th week
    Title
    Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
    Time Frame
    6th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fulya Bakılan
    Organizational Affiliation
    Eskisehir City Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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