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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06301152
Other study ID # E2-22-1905
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date May 30, 2023

Study information

Verified date March 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE). Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 30, 2023
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of Lateral epicondylitis - Age >18 Exclusion Criteria: - Operation history about elbow - Received physical therapy, or had a steroid injection to the elbow in the three months - Cervical radiculopathy, - Elbow deformities, - Fibromyalgia syndrome, - Carpal tunnel syndrome, - Neurological impairments in the upper extremity, - Chronic inflammatory conditions, - Hemophilia, - Pregnant, - History of malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
high intensive laser
high-intensity laser ,three times in a week, for three weeks, 9 session
extracorporeal shock wave therapy
extracorporeal shock wave therapy, once a week, for three weeks ,3 times,

Locations

Country Name City State
Turkey Emine Esra Bilir Ankara Çankaya

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale score 0-10, 0 minimum value, mean is no pain, score 10 is maximum value, pain is very severe Baseline, 1 week and 6 weeks
Secondary Quick Disability Arm, Shoulder and Hand questionary, Quick Disability Arm, Shoulder and Hand questionary, minimum score 0 maximum score 100, high score value is associated with poor functional status Baseline, 1 week and 6 weeks
Secondary hand grip strength evaluates the maximum isometric contraction strength of hand and forearm muscles, 20-69 age male 47-40kg, female 30-24kg is normal value. ow value is associated with poor function Baseline, 1 week and 6 weeks
Secondary musculoskeletal ultrasonography common extensor tendon thickness;>0.40-0.41cm measurement result is associated with thickening of the tendon Baseline, 1 week and 6 weeks
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