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Clinical Trials/NCT05334953
NCT05334953
Completed
Not Applicable

Comparing the Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis: A Randomized Controlled Trial

Bezmialem Vakif University1 site in 1 country68 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lateral Epicondylitis
Sponsor
Bezmialem Vakif University
Enrollment
68
Locations
1
Primary Endpoint
Visual Analog Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.

Detailed Description

Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach. Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
January 6, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged between 18-65 years
  • Pain on the lateral side of the elbow for at least 4 weeks
  • Tenderness over the lateral epicondyle
  • Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)

Exclusion Criteria

  • Be younger than 18
  • Having had ESWT treatment in the elbow area before
  • History of injection, surgery, physical therapy in the elbow area in the last 3 months
  • Previous elbow surgery
  • History of radius/ulna fracture
  • A history of cervical and shoulder problems
  • having bilateral symptoms
  • concomitant medial epicondylitis
  • Malignancy
  • Pregnancy

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: Change from Baseline at 1 month after treatment.

The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale

Secondary Outcomes

  • Grip Strength score(Change from Baseline at 1 month after treatment.)
  • Patient-Rated Tennis Elbow Evaluation (PRTEE) scales(Change from Baseline at 1 month after treatment.)
  • Health Assessment Questionnaire (HAQ) score(Change from Baseline at 1 month after treatment.)
  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score(Change from Baseline at 1 month after treatment.)
  • Roles and Maudsley Score(Change from Baseline at 1 month after treatment.)

Study Sites (1)

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