Lateral EpicondylitisNCT06603181
Effect of Extracorporeal Shock Wave Therapy (ESWT) and Phonophoresis Treatment in Patients With Lateral Epicondylitis
A study testing conventional treatment, phonophoresis and extracorporeal shock wave therapy in people with Lateral Epicondylitis and Extracorporeal Shock Wave Therapy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis, Extracorporeal Shock Wave Therapy, Phonophoresis
- What is being tested?
- conventional treatment, phonophoresis and extracorporeal shock wave therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Those with neurological diseases
- Pregnancy
- Infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University
Kırşehir, Kırşehir
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- conventional treatment, phonophoresis, extracorporeal shock wave therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional treatmentOther
exercise and splint
phonophoresisOther
exercise, splint and phonophoresis
extracorporeal shock wave therapyOther
exercise, splint and ESWT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Other: conventional treatment; Other: extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 2th week, 12th week
Secondary outcomes (3)
Quick-DASH
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.
Measured: baseline, 2th week, 12th week
hand grip strength
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.
Measured: baseline, 2th week, 12th week
tendon thickness
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.
Measured: baseline, 2th week, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Sep 2024
- Primary completion30 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazife Kapan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603181
- Sponsor's protocol ID
- AEÜ-NK-LE
- Status last verified
- Sep 2024
- First submitted
- 7 May 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06603181
- Acronym / sponsor ID
- AEÜ-NK-LE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: conventional treatmentConventional 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. |
| GroupB | Experimental | Other: conventional treatment, Other: phonophoresisConventional 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. |
| Group C | Experimental | Other: conventional treatment, Other: extracorporeal shock wave therapyConventional 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional treatmentexercise and splint | Other | Group A, Group C, GroupB |
| phonophoresisexercise, splint and phonophoresis | Other | GroupB |
| extracorporeal shock wave therapyexercise, splint and ESWT | Other | Group C |
Primary outcome
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.
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.
3 secondary outcomes
Quick-DASH
Time frame: baseline, 2th week, 12th week
hand grip strength
Time frame: baseline, 2th week, 12th week
tendon thickness
Time frame: baseline, 2th week, 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional treatment, phonophoresis and extracorporeal shock wave therapy in people with Lateral Epicondylitis and Extracorporeal Shock Wave Therapy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: baseline, 2th week, 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.