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

NCT03944122 | Completed

• 1 other identifier: FTR
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis, therapeutical ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  2nd week

Secondary Outcomes (3)

• Visual Analog Scale

  6th week

• Duruoz's hand index

  6th week

• Patient-Rated Tennis Elbow Evaluation (PRTEE) scales

  6th week

Study Arms (3)

continuous ultrasound

EXPERIMENTAL

continuous ultrasound were applied to the patients

Device: ultrasound

pulsed ultrasound

EXPERIMENTAL

pulsed ultrasound were applied to the patients

Device: ultrasound

placebo

EXPERIMENTAL

placebo (sham) ultrasound were applied to the patients

Device: ultrasound

Interventions

ultrasound DEVICE

therapeutical ultrasound were applied to the patients

continuous ultrasound; placebo; pulsed ultrasound

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

MeSH Terms

Conditions

Tennis Elbow

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Fulya Bakılan

  Eskisehir City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: the patients and the physician was blind to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Onur Armagan, medical doctor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: May 5, 2013
• Primary Completion: May 5, 2015
• Study Completion: November 5, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05