Physiotherapy Applications in Lateral Epicondylitis

NCT07028840 | Completed

• 1 other identifier: 674325
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) in improving pain, grip strength, and function in patients with lateral epicondylitis. A total of 42 volunteer patients aged 18-65 were enrolled at Balıkesir Private Sevgi Hospital physical medicine polyclinic. Participants were randomly assigned into three groups: group 1 received conventional physiotherapy, group 2 received physiotherapy plus ESWT, and group 3 received physiotherapy plus HILT. Physiotherapy was applied for 2 weeks, totaling 10 sessions. ESWT and HILT were each administered twice weekly for 2 weeks, totaling 4 sessions. Pain was measured using the visual analog scale (VAS), grip strength with a hand dynamometer, and function using the Duruöz Hand Index and PRTEE-T questionnaire. Evaluations were performed before treatment, after 2 weeks, and one month post-treatment.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (4)

• Pain Severity - Visual Analog Scale (VAS)

  Pain intensity will be evaluated using the visual analog scale (VAS), a 10 cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Continuous scale (0-10), higher scores indicate worse outcome.

  Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

• Grip Strength - Hand Dynamometer

  Grip strength will be measured in kilograms using a hand dynamometer. Continuous scale, higher scores indicate better outcome

  Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

• Upper Extremity Function - Duruöz Hand Index

  The Duruöz Hand Index is a functional scale that assesses hand-related disability. Scores range from 0 to 90, with higher scores indicating worse functional impairment.

  Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

• Functional Evaluation - PRTEE-T (Patient-Rated Tennis Elbow Evaluation)

  The PRTEE-T is a 15-item patient-rated questionnaire for lateral epicondylitis. Total scores range from 0 (no disability) to 100 (maximum disability). Continuous scale (0-100), higher scores indicate worse outcome.

  Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

Study Arms (3)

Physiotherapy

ACTIVE COMPARATOR

This group received conventional physiotherapy only

Other: Physiotherapy

Physiotherapy + ESWT

ACTIVE COMPARATOR

This group received conventional physiotherapy and additional extracorporeal shock wave therapy (ESWT)

Other: Physiotherapy; Device: Extracorporeal Shock Wave Therapy (ESWT)

Physiotherapy + HILT

ACTIVE COMPARATOR

This group received conventional physiotherapy and additional high-intensity laser therapy (HILT).

Other: Physiotherapy; Device: High-Intensity Laser Therapy (HILT)

Interventions

Physiotherapy OTHER

10 sessions over 2 weeks, including TENS, cold therapy, ultrasound, and exercise therapy, 5 sessions per week.

Physiotherapy; Physiotherapy + ESWT; Physiotherapy + HILT

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

4 sessions total, applied 2 times per week for 2 weeks.

Physiotherapy + ESWT

High-Intensity Laser Therapy (HILT) DEVICE

4 sessions total, applied 2 times per week for 2 weeks.

Physiotherapy + HILT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over the age of 18,
• Being diagnosed with lateral epicondylitis,
• Not having received lateral epicondylitis treatment in the last 3 months

You may not qualify if:

• Stopping the treatment,
• Those who have been traumatized in the last 3 months,
• Those who use drugs that can affect muscle strength or pain level (muscle relaxants, analgesics, gabapentinoids, etc.)
• Those with open wounds in the elbow area, Those with elbow fractures, Those with drug allergies, Pregnant and breastfeeding women.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Physical Therapy Modalities; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced

Study Officials

• SUAT EREL, PROF.DR.

  PAMUKKALE UNİVERSİTY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF THE DEPARTMENT OF ORTHOPEDIC REHABILITATION

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: June 19, 2025
• Study Start: June 10, 2020
• Primary Completion: September 5, 2020
• Study Completion: December 30, 2020
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: FOR 6 MONTH
• Access Criteria: FOR RESEARCH

Locations

TU (1)