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

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

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.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: high intensive laser; Device: extracorporeal shock wave therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Emine Esra Bilir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high intensive laser; high-intensity laser was applied 3 times in a week, for three weeks, total of 9 sessions	Device: high intensive laser; high-intensity laser ,three times in a week, for three weeks, 9 session
Experimental: extracorporeal shock wave therapy; extracorporeal shock wave therapy was applied once a week, for three weeks total of 3 sessions	Device: extracorporeal shock wave therapy; extracorporeal shock wave therapy, once a week, for three weeks ,3 times,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lateral Epicondylitis; Extracorporeal Shock Wave Therapy; Musculoskeletal ultrasound; High Intensive Laser Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Elbow Injuries; Tennis Elbow
• Other Study ID Numbers: E2-22-1905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No