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
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, therapeutical ultrasound
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
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
NCT ID
NCT03944122
First Posted
May 7, 2019
Last Updated
May 9, 2019
Sponsor
Eskisehir Osmangazi University
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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