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

NCT05334953 | Completed

• 1 other identifier: 71306642-050.05.04
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; extracorporeal shock wave therapy; ultrasound; phonophoresis

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

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

  Change from Baseline at 1 month after treatment.

Secondary Outcomes (5)

• Patient-Rated Tennis Elbow Evaluation (PRTEE) scales

  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.

• Health Assessment Questionnaire (HAQ) score

  Change from Baseline at 1 month after treatment.

• Grip Strength score

  Change from Baseline at 1 month after treatment.

Study Arms (4)

Experimental: ESWT(Extracorporeal Shock Wave Therapy)

EXPERIMENTAL

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

Device: ESWT

Phonophoresis

EXPERIMENTAL

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

Device: Phonophoresis

Ultrasound therapy

EXPERIMENTAL

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

Device: Ultrasound

Control goup

OTHER

Group 4 ( n=17) will be given home exercise program

Other: Control group

Interventions

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

Experimental: ESWT(Extracorporeal Shock Wave Therapy)

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

Phonophoresis

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

Ultrasound therapy

Control group OTHER

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

Control goup

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif university

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Yalvac B, Mesci N, Geler Kulcu D, Yurdakul OV. Comparison of ultrasound and extracorporeal shock wave therapy in lateral epicondylosis. Acta Orthop Traumatol Turc. 2018 Sep;52(5):357-362. doi: 10.1016/j.aott.2018.06.004. Epub 2018 Jun 28.

  PMID: 30497658 BACKGROUND

• Bayram K, Yesil H, Dogan E. Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis. North Clin Istanb. 2014 Aug 3;1(1):33-38. doi: 10.14744/nci.2014.77487. eCollection 2014.

  PMID: 28058299 BACKGROUND

• Stasinopoulos D, Johnson MI. Cyriax physiotherapy for tennis elbow/lateral epicondylitis. Br J Sports Med. 2004 Dec;38(6):675-7. doi: 10.1136/bjsm.2004.013573.

  PMID: 15562158 BACKGROUND

• Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.

  PMID: 26303397 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Phonophoresis; Ultrasonography; Control Groups

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Okan Küçükakkaş, Doç

  okan4494@yahoo.com

  STUDY DIRECTOR

• Elif Uğurlu, MD

  elifdemirbag92qgmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: January 6, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)