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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334953
• Other study ID #: 71306642-050.05.04
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: January 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 6, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Device:
• ESWT
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
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
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:
• Control group
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif university	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change from Baseline at 1 month after treatment.
Secondary	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	Change from Baseline at 1 month after treatment.
Secondary	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.	Change from Baseline at 1 month after treatment.
Secondary	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	Change from Baseline at 1 month after treatment.
Secondary	Grip Strength score	Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer	Change from Baseline at 1 month after treatment.