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

NCT ID: NCT03944122

Last Updated: 2019-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-05

Study Completion Date

2018-11-05

Brief Summary

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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

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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).

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
the patients and the physician was blind to the study

Study Groups

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continuous ultrasound

continuous ultrasound were applied to the patients

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

therapeutical ultrasound were applied to the patients

pulsed ultrasound

pulsed ultrasound were applied to the patients

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

therapeutical ultrasound were applied to the patients

placebo

placebo (sham) ultrasound were applied to the patients

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

therapeutical ultrasound were applied to the patients

Interventions

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ultrasound

therapeutical ultrasound were applied to the patients

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Onur Armağan

Onur Armagan, medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fulya Bakılan

Role: STUDY_DIRECTOR

Eskisehir City Hospital

Other Identifiers

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FTR

Identifier Type: -

Identifier Source: org_study_id

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