Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy

Lateral Epicondylitis Clinical Trial

Official title:

Comparison of High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy in Treatment of Lateral Epicondylitis: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301152
• Other study ID #: E2-22-1905
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

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