Lateral Epicondylitis (Tennis Elbow)NCT07564713
Comparison of Extracorporeal Shock Wave Therapy and Low-Level Laser Therapy in Patients With Lateral Epicondylitis
A study testing ESWT Group and LLLT Group in people with Lateral Epicondylitis (Tennis Elbow), run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Background: Lateral epicondylitis is a common musculoskeletal condition characterized by pain and functional impairment of the elbow, often associated with degenerative changes in the common extensor tendon. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- ESWT Group and LLLT Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Clinical diagnosis of lateral epicondylitis based on physical examination findings
- Symptom duration of at least 6 weeks
- Presence of lateral elbow pain aggravated by wrist extension and/or gripping activities
- Ability to understand and comply with study procedures
- Provision of written informed consent
Who cannot join
- Previous surgery involving the affected elbow
- History of corticosteroid or other injection therapy to the affected elbow within the last 6 months
- Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis)
- Neurological disorders affecting the upper extremity
- Systemic inflammatory or metabolic diseases that may affect tendon structure or healing
- Cervical radiculopathy or other causes of referred upper extremity pain
Show all 9Show fewer
- Pregnancy or breastfeeding
- Use of anticoagulant therapy or bleeding disorders
- Severe comorbid conditions that may interfere with participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic
Çorum
Ayşe Gülşen Doğan, Ass Prof, +905554734440, dr.mdagu@gmail.com
About this study
Official title: Effects of Extracorporeal Shock Wave Therapy Versus Low-Level Laser Therapy on Ultrasonographic Tendon Thickness and Clinical Outcomes in Patients With Lateral Epicondylitis
Background:
Lateral epicondylitis is a common musculoskeletal condition characterized by pain and functional impairment of the elbow, often associated with degenerative changes in the common extensor tendon. Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities; however, comparative evidence regarding their clinical and structural effects remains limited.
Read more
Objective:
This study aims to compare the effects of ESWT and LLLT on pain intensity, elbow function, quality of life, grip strength, and ultrasonographic characteristics of the extensor tendon (thickness and echogenicity) in patients with lateral epicondylitis.
Methods:
This prospective, randomized, single-blind, comparative clinical trial will be conducted at the Physical Medicine and Rehabilitation outpatient clinic. Patients aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be included. All participants will receive a tennis elbow brace and a standardized exercise program. Participants will be randomly assigned to receive either ESWT or LLLT. ESWT will be applied to the lateral epicondyle region using a standardized protocol once weekly for 3 weeks. LLLT will be administered to the same region using standard clinical protocol three times per week for 3 weeks.
Assessments will be performed before and after treatment. Pain will be evaluated using the Visual Analog Scale (VAS), elbow function using the Patient-Rated Tennis Elbow Evaluation (PRTEE), quality of life using the Short Form-36 (SF-36), and grip strength using a hand dynamometer. Ultrasonographic evaluation of the common extensor tendon will be performed by a blinded specialist using a high-frequency linear probe to assess tendon thickness.
Read the detailed description
Lateral epicondylitis is a common overuse disorder characterized by degenerative changes in the common extensor tendon, particularly the extensor carpi radialis brevis. Current evidence suggests that the condition represents a tendinopathic process rather than an inflammatory disorder, emphasizing the importance of treatments targeting both symptom relief and tendon healing.
Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities in clinical practice. ESWT is thought to promote tendon healing through mechanotransduction and neovascularization, whereas LLLT may enhance cellular metabolism, fibroblast proliferation, and collagen synthesis. Although both treatments have demonstrated clinical benefits, comparative data evaluating their effects on both clinical outcomes and tendon structure are limited.
This study is designed as a prospective, randomized, single-blind, comparative clinical trial conducted at the Physical Medicine and Rehabilitation outpatient clinic of Hitit University. Eligible participants aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be randomly assigned to receive either ESWT or LLLT using a computer-generated randomization sequence. Outcome assessors will be blinded to group allocation.
ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Herz, once weekly for 3 weeks). LLLT will be administered to the same anatomical region three times per week for 3 weeks (four points, 40 seconds per point, 4 joules per square centimeter (J/cm²). In addition, all participants will receive a tennis elbow brace and a standardized exercise program. No additional physical therapy modalities or changes in ongoing medical treatments will be allowed during the study period.
Clinical assessments will be performed at baseline and immediately after treatment. Pain intensity will be measured using the Visual Analog Scale (VAS). Elbow function will be evaluated using the Patient-Rated Tennis Elbow Evaluation (PRTEE). Quality of life will be assessed with the Short Form-36 (SF-36), and grip strength will be measured using a hand dynamometer.
Ultrasonographic evaluation will be performed by an experienced physiatrist blinded to treatment allocation, using a high-frequency linear probe. The common extensor tendon will be assessed in both longitudinal and transverse planes. Tendon thickness will be measured in millimeters.
The primary aim is to compare the effects of ESWT and LLLT on pain and tendon thickness, while secondary outcomes include functional scores, quality of life, grip strength, and tendon echogenicity. It is hypothesized that both treatments will improve clinical outcomes, with ESWT potentially providing greater structural improvement in tendon characteristics.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- ESWT Group, LLLT Group
- Keywords
- Lateral epicondylitis, extracorporeal shock wave therapy, ultrasonography, tennis elbow, low level laser 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.
ESWT GroupBehavioural
ESWT will be applied to the lateral epicondyle region using a standardized protocol for 3 sessions in three weeks
LLLT GroupBehavioural
LLLT will be applied to the lateral epicondyle region using a standardized protocol three times per week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| ESWT Group | Experimental | Participants in the experimental group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo extracorporeal shock wave therapy (ESWT). ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Herz, once weekly for 3 weeks). Receives: Behavioral: ESWT Group |
| LLLT Group | Active comparator | Participants in the active comparator group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo low-level laser therapy (LLLT). LLLT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol three times per week for 3 weeks at four points, 40 seconds per point, with a dose of 4 joules per square centimeter (J/cm²). Receives: Behavioral: LLLT Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity will be measured by the Visual Analog Scale (VAS)
Pain intensity will be measured by the Visual Analog Scale (VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to indicate their pain level, and the score will be recorded accordingly.
Measured: Baseline and after 3 weeks of treatment
Secondary outcomes (4)
Elbow function and pain-related disability will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Elbow function and pain-related disability will be assessed by Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. The PRTEE is a validated, patient-reported outcome measure consisting of 15 items evaluating pain and functional limitations. Scores range from 0 to 100, with higher scores indicating greater pain and disability.
Measured: Baseline and after 3 weeks of treatment
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, a validated instrument consisting of 36 items that evaluate eight domains of health-related quality of life, including physical functioning, bodily pain, and mental health. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and after 3 weeks of treatment
Grip strength will be measured using a Jamar hand dynamometer
Grip strength will be measured using a Jamar hand dynamometer in a standardized position. Measurements will be performed three times, and the average value will be recorded.
Measured: Baseline and after 3 weeks of treatment
Ultrasonographic assessment of extensor tendon thickness
Extensor tendon thickness will be measured by an experienced physiatrist blinded to treatment allocation using ultrasonography. Measurements will be performed over the common extensor tendon at the level of the lateral epicondyle using a high-frequency linear probe.
Measured: Baseline and after 3 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start4 May 2026
- Primary completion29 Sep 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies 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
- Parallel groups
- Model description
- Participants will be randomly allocated in a 1:1 ratio to receive either extracorporeal shock wave therapy (ESWT) or low-level laser therapy (LLLT). In addition to the assigned intervention, all participants will be provided with a tennis elbow brace and a standardized exercise program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Özge Başaran, Hitit University
- Investigators
- Pınar Başaran, Dr, Principal investigator, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564713
- Sponsor's protocol ID
- 2026-15
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional regulations and the absence of participant consent for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave Therapy Versus Low-Level Laser Therapy on Ultrasonographic Tendon Thickness and Clinical Outcomes in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07564713
- Acronym / sponsor ID
- 2026-15
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Lateral epicondylitis, extracorporeal shock wave therapy, ultrasonography, tennis elbow, low level laser therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 4 May 2026 (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.
Background:
Lateral epicondylitis is a common musculoskeletal condition characterized by pain and functional impairment of the elbow, often associated with degenerative changes in the common extensor tendon. Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities; however, comparative evidence regarding their clinical and structural effects remains limited.
Objective:
This study aims to compare the effects of ESWT and LLLT on pain intensity, elbow function, quality of life, grip strength, and ultrasonographic characteristics of the extensor tendon (thickness and echogenicity) in patients with lateral epicondylitis.
Methods:
This prospective, randomized, single-blind, comparative clinical trial will be conducted at the Physical Medicine and Rehabilitation outpatient clinic. Patients aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be included. All participants will receive a tennis elbow brace and a standardized exercise program. Participants will be randomly assigned to receive either ESWT or LLLT. ESWT will be applied to the lateral epicondyle region using a standardized protocol once weekly for 3 weeks. LLLT will be administered to the same region using standard clinical protocol three times per week for 3 weeks.
Assessments will be performed before and after treatment. Pain will be evaluated using the Visual Analog Scale (VAS), elbow function using the Patient-Rated Tennis Elbow Evaluation (PRTEE), quality of life using the Short Form-36 (SF-36), and grip strength using a hand dynamometer. Ultrasonographic evaluation of the common extensor tendon will be performed by a blinded specialist using a high-frequency linear probe to assess tendon thickness.
Detailed description
Lateral epicondylitis is a common overuse disorder characterized by degenerative changes in the common extensor tendon, particularly the extensor carpi radialis brevis. Current evidence suggests that the condition represents a tendinopathic process rather than an inflammatory disorder, emphasizing the importance of treatments targeting both symptom relief and tendon healing.
Extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) are widely used noninvasive treatment modalities in clinical practice. ESWT is thought to promote tendon healing through mechanotransduction and neovascularization, whereas LLLT may enhance cellular metabolism, fibroblast proliferation, and collagen synthesis. Although both treatments have demonstrated clinical benefits, comparative data evaluating their effects on both clinical outcomes and tendon structure are limited.
This study is designed as a prospective, randomized, single-blind, comparative clinical trial conducted at the Physical Medicine and Rehabilitation outpatient clinic of Hitit University. Eligible participants aged 18-65 years with clinically diagnosed lateral epicondylitis and symptom duration of at least six weeks will be randomly assigned to receive either ESWT or LLLT using a computer-generated randomization sequence. Outcome assessors will be blinded to group allocation.
ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Herz, once weekly for 3 weeks). LLLT will be administered to the same anatomical region three times per week for 3 weeks (four points, 40 seconds per point, 4 joules per square centimeter (J/cm²). In addition, all participants will receive a tennis elbow brace and a standardized exercise program. No additional physical therapy modalities or changes in ongoing medical treatments will be allowed during the study period.
Clinical assessments will be performed at baseline and immediately after treatment. Pain intensity will be measured using the Visual Analog Scale (VAS). Elbow function will be evaluated using the Patient-Rated Tennis Elbow Evaluation (PRTEE). Quality of life will be assessed with the Short Form-36 (SF-36), and grip strength will be measured using a hand dynamometer.
Ultrasonographic evaluation will be performed by an experienced physiatrist blinded to treatment allocation, using a high-frequency linear probe. The common extensor tendon will be assessed in both longitudinal and transverse planes. Tendon thickness will be measured in millimeters.
The primary aim is to compare the effects of ESWT and LLLT on pain and tendon thickness, while secondary outcomes include functional scores, quality of life, grip strength, and tendon echogenicity. It is hypothesized that both treatments will improve clinical outcomes, with ESWT potentially providing greater structural improvement in tendon characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 1:1 ratio to receive either extracorporeal shock wave therapy (ESWT) or low-level laser therapy (LLLT). In addition to the assigned intervention, all participants will be provided with a tennis elbow brace and a standardized exercise program.
| Arm | Type | Receives |
|---|---|---|
| ESWT Group | Experimental | Behavioral: ESWT GroupParticipants in the experimental group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo extracorporeal shock wave therapy (ESWT). ESWT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol (1.6 bar, 2000 pulses, 10 Herz, once weekly for 3 weeks). |
| LLLT Group | Active comparator | Behavioral: LLLT GroupParticipants in the active comparator group will receive a tennis elbow brace and a standardized exercise program, and additionally undergo low-level laser therapy (LLLT). LLLT will be applied to the lateral epicondyle region over the common extensor tendon using a standardized protocol three times per week for 3 weeks at four points, 40 seconds per point, with a dose of 4 joules per square centimeter (J/cm²). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of lateral epicondylitis based on physical examination findings
- Symptom duration of at least 6 weeks
- Presence of lateral elbow pain aggravated by wrist extension and/or gripping activities
- Ability to understand and comply with study procedures
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Previous surgery involving the affected elbow
- History of corticosteroid or other injection therapy to the affected elbow within the last 6 months
- Presence of inflammatory rheumatic diseases (e.g., rheumatoid arthritis)
- Neurological disorders affecting the upper extremity
- Systemic inflammatory or metabolic diseases that may affect tendon structure or healing
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 |
|---|---|---|
| ESWT GroupESWT will be applied to the lateral epicondyle region using a standardized protocol for 3 sessions in three weeks | Behavioural | ESWT Group |
| LLLT GroupLLLT will be applied to the lateral epicondyle region using a standardized protocol three times per week for 3 weeks | Behavioural | LLLT Group |
Primary outcome
Pain intensity will be measured by the Visual Analog Scale (VAS)
Time frame: Baseline and after 3 weeks of treatment
Pain intensity will be measured by the Visual Analog Scale (VAS), a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to indicate their pain level, and the score will be recorded accordingly.
4 secondary outcomes
Elbow function and pain-related disability will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Time frame: Baseline and after 3 weeks of treatment
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire
Time frame: Baseline and after 3 weeks of treatment
Grip strength will be measured using a Jamar hand dynamometer
Time frame: Baseline and after 3 weeks of treatment
Ultrasonographic assessment of extensor tendon thickness
Time frame: Baseline and after 3 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional regulations and the absence of participant consent for public data sharing.
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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.
Pınar Başaran, Dr principal investigator
Hitit 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 ESWT Group and LLLT Group in people with Lateral Epicondylitis (Tennis Elbow), run by Hitit University 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: looking for participants now, as of the sponsor's last update on 16 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pınar Başaran, Dr (00903642230300 ext. 2251, pinarozge@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity will be measured by the Visual Analog Scale (VAS) (time frame: Baseline and after 3 weeks of treatment). 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 16 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.