An interventional study of ESWT and Phonophoresis in Lateral Epicondylitis, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 68 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.
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Exclusion Criteria:
Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Device: ESWT
Group 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program
Device: Phonophoresis
Group 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program
Device: Ultrasound
Group 4 ( n=17) will be given home exercise program
Other: Control group
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
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
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
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Visual Analog Scale
The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale
Time frame: Change from Baseline at 1 month after treatment.
Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis
Time frame: Change from Baseline at 1 month after treatment.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score
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
Time frame: Change from Baseline at 1 month after treatment.
Roles and Maudsley Score
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.
Time frame: Change from Baseline at 1 month after treatment.
Health Assessment Questionnaire (HAQ) score
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
Time frame: Change from Baseline at 1 month after treatment.
Grip Strength score
Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
Time frame: Change from Baseline at 1 month after treatment.
Plan to share: No
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Bezmialem Vakif University