Lateral EpicondylitisNCT07282431
Shockwave Therapy Plus Exercise for Lateral Epicondylitis
A study testing Extracorporeal Shock Wave Therapy (ESWT) and exercise therapy in people with Lateral Epicondylitis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT) and exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 15 Feb 2026
- 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
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Individuals with the following characteristics will be included in the study:
- Being 18 years of age or older
- Having a clinical diagnosis of lateral epicondylitis
- Not having received any other similar treatment within the last 6 months
- Having the cognitive ability to understand the Turkish questionnaire and assessment forms
- Voluntarily agreeing to participate in the study and providing written informed consent
Exclusion Criteria: Individuals with one or more of the following conditions will be excluded from the study:
- Having a history of concomitant systemic, rheumatological, or inflammatory diseases that could affect pain
- Having a history of trauma, surgery, or neurological disease in the upper extremity
- Presence of conditions other than lateral epicondylitis, such as tendinopathy, bursitis, or nerve entrapment
- Having major psychiatric disorders that could affect the pain threshold (e.g., major depression, schizophrenia)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul medipol University
Istanbul, Beykoz, 34000
About this study
Official title: Clinical Effectiveness of Extracorporeal Shock Wave Therapy Combined With Exercise in Patients With Lateral Epicondylitis
The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success.
Read the detailed description
This randomized, controlled, prospective clinical trial aims to compare the effectiveness of exercise therapy alone versus exercise therapy combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals diagnosed with lateral epicondylitis. The study is conducted at a single center and includes adult participants who meet predefined eligibility criteria.
Participants are randomly assigned to one of two groups: an exercise-only group and an exercise-plus-ESWT group. Both groups follow a 4-week treatment program consisting of 12 sessions delivered three times per week. The exercise program includes isometric, isotonic, and stretching exercises targeting wrist extensors and related musculature. These exercises are demonstrated and supervised by physiotherapists, with participants encouraged to continue them as a home program.
In the intervention group, ESWT is administered once weekly for a total of four sessions. A radial-type ESWT device is used with preset parameters (2.0 bar pressure, 10 Hz frequency, 2000 pulses per session). All ESWT applications are performed by trained physiotherapists.
Clinical assessments occur at baseline and at the end of the 4-week intervention. Pain intensity, upper-extremity functional capacity, and condition-specific functional limitations are measured using validated outcome tools. Global improvement is also recorded at post-treatment to evaluate the participant's perceived benefit.
This study is designed to provide comparative data on the added value of ESWT when combined with a structured exercise program for the management of lateral epicondylitis, with the goal of informing clinical decision-making and optimizing treatment strategies.
- Conditions
- Lateral Epicondylitis
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT), exercise therapy
- Keywords
- Lateral epicondylitis 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.
Extracorporeal Shock Wave Therapy (ESWT)Other
Extracorporeal Shock Wave Therapy (ESWT)
exercise therapyOther
exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Participants will be randomly assigned to two groups; one group will receive exercise therapy alone, Receives: Other: exercise therapy |
| Extracorporeal Shock Wave Therapy (ESWT) | Experimental | Participants will be randomly assigned to two groups; one group will receive exercise therapy alone, while the other group will receive exercise plus Extracorporeal Shock Wave Therapy (ESWT). Clinical efficacy will be assessed by pre- and post-treatment measurements. Receives: Other: Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.
Pain Intensity (Visual Analog Scale - VAS) Description: Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level on the line.
Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse pain.
Measured: 8 week
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH)
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH) Description: Functional status will be measured using the QuickDASH questionnaire. Scores range from 0 (no disability) to 100 (severe disability).
Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse functional impairment.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Jun 2025
- Primary completion15 Jan 2026
- Study completion15 Feb 2026
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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salih tan, Istanbul Medipol University Hospital
- Investigators
- Salih tan, doctorate, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282431
- Sponsor's protocol ID
- MST-1
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Extracorporeal Shock Wave Therapy Combined With Exercise in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07282431
- Acronym / sponsor ID
- MST-1
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral epicondylitis Extracorporeal Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 15 Dec 2025 (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.
The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success.
Detailed description
This randomized, controlled, prospective clinical trial aims to compare the effectiveness of exercise therapy alone versus exercise therapy combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals diagnosed with lateral epicondylitis. The study is conducted at a single center and includes adult participants who meet predefined eligibility criteria.
Participants are randomly assigned to one of two groups: an exercise-only group and an exercise-plus-ESWT group. Both groups follow a 4-week treatment program consisting of 12 sessions delivered three times per week. The exercise program includes isometric, isotonic, and stretching exercises targeting wrist extensors and related musculature. These exercises are demonstrated and supervised by physiotherapists, with participants encouraged to continue them as a home program.
In the intervention group, ESWT is administered once weekly for a total of four sessions. A radial-type ESWT device is used with preset parameters (2.0 bar pressure, 10 Hz frequency, 2000 pulses per session). All ESWT applications are performed by trained physiotherapists.
Clinical assessments occur at baseline and at the end of the 4-week intervention. Pain intensity, upper-extremity functional capacity, and condition-specific functional limitations are measured using validated outcome tools. Global improvement is also recorded at post-treatment to evaluate the participant's perceived benefit.
This study is designed to provide comparative data on the added value of ESWT when combined with a structured exercise program for the management of lateral epicondylitis, with the goal of informing clinical decision-making and optimizing treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: exercise therapyParticipants will be randomly assigned to two groups; one group will receive exercise therapy alone, |
| Extracorporeal Shock Wave Therapy (ESWT) | Experimental | Other: Extracorporeal Shock Wave Therapy (ESWT)Participants will be randomly assigned to two groups; one group will receive exercise therapy alone, while the other group will receive exercise plus Extracorporeal Shock Wave Therapy (ESWT). Clinical efficacy will be assessed by pre- and post-treatment measurements. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT)Extracorporeal Shock Wave Therapy (ESWT) | Other | Extracorporeal Shock Wave Therapy (ESWT) |
| exercise therapyexercise therapy | Other | Control Group |
Primary outcome
Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.
Time frame: 8 week
Pain Intensity (Visual Analog Scale - VAS) Description: Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level on the line. Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse pain.
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH)
Time frame: 8 week
Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH) Description: Functional status will be measured using the QuickDASH questionnaire. Scores range from 0 (no disability) to 100 (severe disability). Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse functional impairment.
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Salih tan, doctorate study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) and exercise therapy in people with Lateral Epicondylitis, run by Istanbul Medipol University Hospital 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?
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 28 Oct 2026. 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?
Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone. (time frame: 8 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 28 Oct 2026.