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Completed

NCT Number: NCT05334953

Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif university

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Systemic rheumatologic disease or systemic infection
  • inserted cardiac pacemaker
  • presence of coagulation disorders
  • Cognitive disfunction

Treatment and study plan

ESWT

Device

Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

Phonophoresis

Device

Group 2 ( n=17) will be given five times a week total 10 sessions of diclofenac phonophoresis + home exercise program

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

Ultrasound

Device

Group 3 (n=17) will be given five times a week total 10 sessions of ultrasound therapy+ home exercise program

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

Control Group

Other

Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

Primary outcomes

  1. 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

  1. Patient-Rated Tennis Elbow Evaluation (PRTEE) scales

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

    The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis

  2. Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score

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

    The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness

  3. Roles and Maudsley Score

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

    The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair and 4 points = poor.

  4. Health Assessment Questionnaire (HAQ) score

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

    This is a self-reported questionnaire covering 20 items in eight domains related to measuring difficulty in performing activities of daily living: dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities

  5. Grip Strength score

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

    Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 19, 2022
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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