Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment in Patients With Lateral Epicondylitis

NCT06603181 | Completed

• 1 other identifier: AEÜ-NK-LE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the effects of Extracorporeal Shock Wave Therapy and phonophoresis treatment on pain, function, hand grip strength and tendon thickness in ultrasonography in patients with lateral epicondylitis.

Conditions

Extracorporeal Shock Wave Therapy; Phonophoresis; Lateral Epicondylitis

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  VAS is a pain rating scale with numbers 0 and 10. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale. Patients' night, rest and activity pain will be evaluated separately.

  baseline, 2th week, 12th week

• Patient-based lateral epicondylitis assessment questionnaire

  It is a specific assessment questionnaire for lateral epicondylitis. It consists of two parts. In the first part, the pain in the affected arm is evaluated, and in the second part, the level of functionality is evaluated. In the second part, the functionality level is divided into two parts: specific activities and daily activities. In total, the best score is evaluated as 0 and the worst score is evaluated as 100.

  baseline, 2th week, 12th week

Secondary Outcomes (3)

• Quick-DASH

  baseline, 2th week, 12th week

• hand grip strength

  baseline, 2th week, 12th week

• tendon thickness

  baseline, 2th week, 12th week

Study Arms (3)

Group A

EXPERIMENTAL

Conventional Treatment Patients in this group will be given activity modification and home exercise program training, including stretching and eccentric strengthening exercises. Patients will be asked to perform the exercise treatment in 3 sets of 10 repetitions. Additionally, a splint will be recommended to rest the arm.

Other: conventional treatment

GroupB

EXPERIMENTAL

Conventional Treatment and Phonophoresis Patients in this group will receive phonophoresis treatment in addition to a home exercise program and splint. A US device (Intelect 2776 Combo; Chattanoga Group, Inc, Chattanoga, TN) will be used for phonophoresis. The gel containing 10% naproxen will be mixed with aquasonic us gel to better deliver the drug through the body. Continuous mode at 1watt/cm2 1mhz frequency will be applied around the lateral epicondyle for 5 minutes. Sessions will be applied 5 sessions per week for 2 weeks.

Other: conventional treatment; Other: phonophoresis

Group C

EXPERIMENTAL

Conventional Treatment and Ekstrakorporeal shock wave therapy Patients in this group will receive ESWT treatment in addition to a home exercise program and splint. ESWT; With the MODUS ESWT system, 2 sessions per week will be applied to the lateral epicondyle (2.4 bar intensity, 15 Hz frequency, 1500 pulses) for 2 weeks (Modus ESWT® RadialShockwaveTherapy).

Other: conventional treatment; Other: extracorporeal shock wave therapy

Interventions

extracorporeal shock wave therapy OTHER

exercise, splint and ESWT

Group C

conventional treatment OTHER

exercise and splint

Group A; Group C; GroupB

phonophoresis OTHER

exercise, splint and phonophoresis

GroupB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-65
• Those who signed the informed consent form
• Painful palpation of the lateral epicondyle
• Positive Mill\'s, Maudsley\'s and Cozen\'s tests
• Patients who have had complaints for at least 3 months

You may not qualify if:

• Those who have had corticosteroid, PRP, prolotherapy, hyaluronic acid etc. injections into the elbow area within 3 months or those who have received physical therapy
• Those with cervical radiculopathy
• Those who have had surgery on the elbow
• Those with an open wound on the elbow
• Those with a history of malignancy
• Those with rheumatological diseases
• Those with neurological diseases
• Pregnancy
• Infection

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Kırşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Phonophoresis; 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)

Drug Administration Routes; Drug Therapy; Therapeutics; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: September 19, 2024
• Study Start: September 25, 2024
• Primary Completion: January 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2024-09

Locations

TU (1)