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

Not Applicable
Completed
Conditions
Lateral Epicondylitis
Interventions
Device: Phonophoresis
Other: Control group
Device: ESWT
Device: Ultrasound
Registration Number
NCT05334953
Lead Sponsor
Bezmialem Vakif University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
68
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PhonophoresisPhonophoresisGroup 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program
Control goupControl groupGroup 4 ( n=17) will be given home exercise program
Experimental: ESWT(Extracorporeal Shock Wave Therapy)ESWTGroup 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Ultrasound therapyUltrasoundGroup 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program
Primary Outcome Measures
NameTimeMethod
Visual Analog ScaleChange 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 Outcome Measures
NameTimeMethod
Grip Strength scoreChange from Baseline at 1 month after treatment.

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

Patient-Rated Tennis Elbow Evaluation (PRTEE) scalesChange 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

Health Assessment Questionnaire (HAQ) scoreChange 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

Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire scoreChange 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

Roles and Maudsley ScoreChange 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.

Trial Locations

Locations (1)

Bezmialem Vakif university

🇹🇷

Istanbul, Turkey

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