- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06603181
Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment in Patients With Lateral Epicondylitis
Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment on Pain, Function, Grip Strength and Tendon Thickness in Ultrasonography in Patients With Lateral Epicondylitis.
Study Overview
Status
Intervention / Treatment
Detailed Description
Lateral epicondylitis (LE) is tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use, forced wrist extension, or direct trauma to the epicondyle. It is the most common cause of lateral elbow pain. Although also known as tennis elbow, lateral epicondylitis often develops as a work-related condition and is therefore a significant public health problem.
ESWT; It involves transmitting high-intensity acoustic pressure waves produced by electrohydraulic, electromagnetic or piezoelectric devices to the target area of the body in a short time through the gel. It has been reported that ESWT increases collagen synthesis in tendons, bones and other soft tissues, accelerates vascularization and reduces pain.
ultrasound; It has been used for many years in the treatment of musculoskeletal disorders such as tendinitis, epicondylitis, tenosynovitis, bursitis and osteoarthritis. It produces acoustic waves through the conversion of electrical energy. These waves turn into heat as they pass through tissues at different resistance levels. Ultrasound is also used to enhance percutaneous absorption of drugs in phonophoresis applications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kırşehir
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Kırşehir, Kırşehir, Turkey (Türkiye)
- Kırşehir Ahi Evran University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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.
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exercise and splint
|
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Experimental: GroupB
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.
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exercise and splint
exercise, splint and phonophoresis
|
|
Experimental: Group C
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).
|
exercise and splint
exercise, splint and ESWT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: baseline, 2th week, 12th week
|
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
Time Frame: baseline, 2th week, 12th week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick-DASH
Time Frame: baseline, 2th week, 12th week
|
It is an evaluation questionnaire that measures activity and participation limitations in all upper extremity disorders.
In the survey, patients' difficulties during daily living activities are questioned with 11 questions.
Each answer is scored on a Likert scale from 1 to 5, from best to worst.
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baseline, 2th week, 12th week
|
|
hand grip strength
Time Frame: baseline, 2th week, 12th week
|
It will be done with a Jamar dynamometer.
Patients will be seated in a chair with their elbows flexed at 90 degrees and their forearms in a neutral position.
They will be asked to squeeze the dynamometer for a maximum of 3 seconds, and this will be repeated 3 times, with a 60-second rest in the meantime.
The average of 3 results will be recorded.
|
baseline, 2th week, 12th week
|
|
tendon thickness
Time Frame: baseline, 2th week, 12th week
|
Extensor tendon thickness measurement will be performed by the same researcher under clinical ultrasound guidance.
Plato technique will be used.
The plateau is located between the attachment site of the extensor tendon and the humeroradial joint.
Tendon thickness is measured perpendicularly from the plateau to the tendon surface.
|
baseline, 2th week, 12th week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Elbow Tendinopathy
- Elbow Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Wounds and Injuries
- Tendon Injuries
- Arm Injuries
- Tendinopathy
- Tennis Elbow
- Therapeutics
- Drug Administration Routes
- Drug Therapy
- Physical Therapy Modalities
- Rehabilitation
- Ultrasonic Therapy
- Diathermy
- Hyperthermia, Induced
- Extracorporeal Shockwave Therapy
- Phonophoresis
Other Study ID Numbers
- AEÜ-NK-LE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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