Clinical trial NCT03944122: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis, therapeutical ultrasound
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: measuring the thickness of common extensor tendon by ultrasound imaging.
timeFrame: 2nd week
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 6th week
measure: Duruoz's hand index
timeFrame: 6th week
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
timeFrame: 6th week
Other outcomes:
Locations:
Study officials:
affiliation: Eskisehir City Hospital
name: Fulya Bakılan
role: STUDY_DIRECTOR
References: