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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05334953
Other study ID # 71306642-050.05.04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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