ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation

Not Applicable

Completed

• Conditions: Lateral Epicondylitis; Tennis Elbow
• Interventions: Device: Extracorporeal Shock Wave Therapy (ESWT); Device: Sham ESWT; Behavioral: Resting Splint , Exercises and ice

• Registration Number: NCT06342518
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.

Detailed Description

42 patients with tennis elbow were split into two groups by chance: one group received shock wave therapy (ESWT), while the other received a fake treatment (Sham-ESWT) for comparison. Both groups underwent wrist exercises, splint usage, and ice application. Grip strength, pain levels, and how well they could move their wrist (functionality) were measured before, after, and one month post-treatment using tests. Additionally, the thickness of a common extensor tendon (CET) was evaluated using ultrasound. The patient, the doctor checking the patient, and the doctor doing the ultrasound didn't know which group the patient was in.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months

Exclusion Criteria

• Patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, PRP, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT GROUP	Resting Splint , Exercises and ice	The ESWT group received radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.
ESWT GROUP	Extracorporeal Shock Wave Therapy (ESWT)	The ESWT group received radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.
Sham-ESWT group	Sham ESWT	The Sham-ESWT group received Sham radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.
Sham-ESWT group	Resting Splint , Exercises and ice	The Sham-ESWT group received Sham radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups.

Primary Outcome Measures

Name	Time	Method
Hand Grip Strength	Baseline, post-treatment(4th week), and one-month post-treatment (8th week)	measured using the Jamar hand dynamometer
Functionality	Baseline, post-treatment(4th week), and one-month post-treatment (8th week)	the Patient-Rated Tennis Elbow Evaluation (PRTEE); The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) Pain - 5 items; 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability).; Pain Score = Sum of the 5 pain items(out of 50) Best Score = 0, Worst Score =50 Function Score = Sum of the 10 function items, Divided by 2 (out of 50) Best Score = 0, Worst Score = 50; Computing the Total Score Total Score = Sum of pain + function scores Best Score = 0, Worst Score = 50 Best Score = 0, Worst Score = 100
Quality of life score	Baseline, post-treatment(4th week), and one-month post-treatment (8th week)	Short Form-12 (SF-12), Patients are provided with the SF-12 questionnaire, which consists of 12 questions covering physical and mental health domains.; The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).; PCS mean score: 56,5 MSC mean score: 60.7 Scores above mean indicate a better-than-average health-related quality of life, while scores below mean suggest below-average health.
Pain severity	Baseline, post-treatment(4th week), and one-month post-treatment (8th week)	Visual Analog Scale (VAS) which was scored from 0 (no pain) to 10 (extremely severe).
thickness of the common extensor tendon (CET)	Baseline, post-treatment(4th week), and one-month post-treatment (8th week)	During ultrasonography for LE, the elbow is positioned in 90 degrees of flexion and the wrist in pronation. The ultrasound probe is placed longitudinally on the radial surface of the elbow. And common extensor tendon thickness was measured sonographically.
deep muscular tissue sensitivity	Baseline, post-treatment(4th week), and one-month post-treatment (8th week)	pain pressure threshold (PPT) Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle.

Trial Locations

Locations (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department; 🇹🇷 Istanbul, Turkey