Lateral EpicondylitisNCT07802938
Pulsed Electromagnetic Field Therapy Added to ESWT for Lateral Epicondylitis
A study testing Pulsed Electromagnetic Field Therapy, Extracorporeal Shock Wave Therapy and Home Exercise Program in people with Lateral Epicondylitis, run by Ali Güneri.
Trial summary
This randomized, sham-controlled, assessor-blinded clinical trial will evaluate the efficacy of pulsed electromagnetic field therapy (PEMF) added to extracorporeal shock wave therapy (ESWT) in adults with lateral epicondylitis. 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?
- Pulsed Electromagnetic Field Therapy, Extracorporeal Shock Wave Therapy and Home Exercise Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2026to 14 Jan 2027
- 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
- Age between 18 and 65 years
- Symptom duration of at least 3 months
- Clinical diagnosis of unilateral lateral epicondylitis
- Numeric Rating Scale (NRS) pain score of at least 4
- Ability and willingness to provide written informed consent
Who cannot join
- Injection treatment, including corticosteroid or platelet-rich plasma (PRP), within the previous 6 months
- Previous application of physical therapy modalities to the affected region
- Cervical radiculopathy, peripheral nerve entrapment neuropathy, or another neurological condition that may mimic lateral elbow pain
- Uncontrolled diabetes mellitus, defined as HbA1c >8%, or the presence of diabetic peripheral neuropathy
- Rheumatoid arthritis or other inflammatory rheumatic diseases
- Previous surgery involving the affected elbow
Show all 14Show fewer
- Elbow instability, significant limitation of joint range of motion, extensor tendon rupture, or a history of major trauma to the elbow
- Other shoulder or upper extremity disorders that may explain lateral elbow pain
- Active infection or open wound at the treatment site
- Malignancy
- Presence of a pacemaker, defibrillator, electronic implant, or other active implanted device
- Pregnancy
- Coagulopathy or anticoagulant use
- Inability to complete the questionnaires because of cognitive impairment or expected poor adherence to follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Pulsed Electromagnetic Field Therapy as an Adjunct to Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Sham-Controlled Trial
This randomized, sham-controlled, assessor-blinded clinical trial will evaluate the efficacy of pulsed electromagnetic field therapy (PEMF) added to extracorporeal shock wave therapy (ESWT) in adults with lateral epicondylitis. A total of 70 participants will be randomly assigned to receive either ESWT plus active PEMF or ESWT plus sham PEMF. Both groups will also receive the same standardized home exercise program. Treatment will be administered once weekly for 5 weeks. Participants will be assessed before treatment, at the end of the 5-week treatment period, and 3 months after treatment. The primary outcome will be the Patient-Rated Tennis Elbow Evaluation (PRTEE) total score. Secondary outcomes will include pain intensity measured using the Numeric Rating Scale, pressure pain threshold, maximum and pain-free grip strength, and ultrasonographic assessment of the common extensor tendon, including tendon thickness, hypoechogenicity, and fibrillar pattern abnormalities.
- Conditions
- Lateral Epicondylitis
- Being tested
- Pulsed Electromagnetic Field Therapy, Sham Pulsed Electromagnetic Field Therapy, Extracorporeal Shock Wave Therapy, Home Exercise Program
- Keywords
- Lateral Epicondylitis, Extracorporeal Shock Wave Therapy, ESWT, Pulsed Electromagnetic Field Therapy, PEMF, Patient-Rated Tennis Elbow Evaluation
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field TherapyDevice
Also called PEMF
Active pulsed electromagnetic field therapy will be applied before each ESWT session for 30 minutes, once weekly for 5 weeks. According to the study protocol, PEMF will be delivered at 25 Hz and 4.6 Hz sequentially, with a total of 6 mT per session.
Sham Pulsed Electromagnetic Field TherapyDevice
Also called Sham PEMF
Sham PEMF will be applied before ESWT using the same duration and positioning as active PEMF. The device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field.
Extracorporeal Shock Wave TherapyDevice
Also called ESWT
Extracorporeal shock wave therapy will be applied to the point of maximum tenderness over the lateral epicondyle using 2000 shocks per session at 1.5-2.0 bar and 10 Hz, once weekly for 5 weeks. Transmission gel will be used and local anesthesia will not be administered.
Home Exercise ProgramBehavioural
All participants will receive the same standardized home exercise program. The program will include eccentric wrist extension (3 sets of 15 repetitions once daily), isometric wrist extension (3 sets of 30-second contractions once daily), and static stretching exercises targeting the forearm flexor and extensor muscle groups (3 sets of 30-second holds twice daily). The exercises will be demonstrated individually at the first session and supported with a written and visual exercise brochure. Exercise adherence will be checked and recorded weekly before each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| ESWT + Active PEMF | Experimental | Participants will receive active pulsed electromagnetic field therapy (PEMF) followed by extracorporeal shock wave therapy (ESWT) once weekly for 5 weeks. All participants will also receive the same standardized home exercise program. Receives: Device: Pulsed Electromagnetic Field Therapy; Device: Extracorporeal Shock Wave Therapy; Behavioral: Home Exercise Program |
| ESWT + Sham PEMF | Sham comparator | Participants will receive sham pulsed electromagnetic field therapy (PEMF) followed by the same extracorporeal shock wave therapy (ESWT) protocol once weekly for 5 weeks. The sham device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field. All participants will also receive the same standardized home exercise program. Receives: Device: Sham Pulsed Electromagnetic Field Therapy; Device: Extracorporeal Shock Wave Therapy; Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score
The PRTEE is a lateral epicondylitis-specific questionnaire consisting of a pain subscale and a function subscale. The total score ranges from 0 to 100, with higher scores indicating greater pain and functional impairment.
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in PRTEE Pain Subscale Score
The PRTEE pain subscale consists of 5 items and ranges from 0 to 50, with higher scores indicating greater pain.
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in PRTEE Function Subscale Score
The PRTEE function subscale consists of 10 items and ranges from 0 to 50, with higher scores indicating greater functional impairment.
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Secondary outcomes (7)
Change in Pain Intensity Measured by the Numeric Rating Scale
Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Pressure Pain Threshold
Pressure pain threshold over the lateral epicondyle will be measured using a pressure algometer with a 1.0 cm² probe. Three measurements will be obtained and the mean value will be recorded in kg/cm².
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Maximum Grip Strength
Maximum grip strength will be measured using a Jamar hydraulic hand dynamometer. Three measurements will be performed and the mean value will be recorded in kilograms (kg).
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Pain-Free Grip Strength
Pain-free grip strength will be measured using a Jamar hydraulic hand dynamometer. Three measurements will be performed and the mean value will be recorded in kilograms (kg).
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Common Extensor Tendon Thickness
Common extensor tendon thickness will be assessed by ultrasonography in the longitudinal plane at the lateral epicondyle origin. Maximum tendon thickness will be recorded in millimeters (mm).
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Common Extensor Tendon Hypoechogenicity
The presence of hypoechoic areas within the common extensor tendon will be assessed by ultrasonography and recorded as present or absent.
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Common Extensor Tendon Fibrillar Pattern
Abnormality of the fibrillar pattern of the common extensor tendon will be assessed by ultrasonography and recorded as present or absent.
Measured: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start2 Sep 2026 (estimated)
- Primary completion14 Jan 2027 (estimated)
- Study completion14 Jan 2027 (estimated)
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Güneri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Güneri, Gaziantep City Hospital
- Investigators
- Ali Güneri, MD, Principal investigator, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802938
- Sponsor's protocol ID
- HU-KAEK-2026-00076
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been finalized and will be determined in accordance with ethical approval, participant consent, and the data-sharing requirements of the journal at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Electromagnetic Field Therapy as an Adjunct to Extracorporeal Shock Wave Therapy in Lateral Epicondylitis: A Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07802938
- Acronym / sponsor ID
- HU-KAEK-2026-00076
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Extracorporeal Shock Wave Therapy, ESWT, Pulsed Electromagnetic Field Therapy, PEMF, Patient-Rated Tennis Elbow Evaluation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ali GüneriUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 14 Jan 2027 (estimated)
- First posted
- 3 Sep 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.
This randomized, sham-controlled, assessor-blinded clinical trial will evaluate the efficacy of pulsed electromagnetic field therapy (PEMF) added to extracorporeal shock wave therapy (ESWT) in adults with lateral epicondylitis. A total of 70 participants will be randomly assigned to receive either ESWT plus active PEMF or ESWT plus sham PEMF. Both groups will also receive the same standardized home exercise program. Treatment will be administered once weekly for 5 weeks. Participants will be assessed before treatment, at the end of the 5-week treatment period, and 3 months after treatment. The primary outcome will be the Patient-Rated Tennis Elbow Evaluation (PRTEE) total score. Secondary outcomes will include pain intensity measured using the Numeric Rating Scale, pressure pain threshold, maximum and pain-free grip strength, and ultrasonographic assessment of the common extensor tendon, including tendon thickness, hypoechogenicity, and fibrillar pattern abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT + Active PEMF | Experimental | Device: Pulsed Electromagnetic Field Therapy, Device: Extracorporeal Shock Wave Therapy, Behavioral: Home Exercise ProgramParticipants will receive active pulsed electromagnetic field therapy (PEMF) followed by extracorporeal shock wave therapy (ESWT) once weekly for 5 weeks. All participants will also receive the same standardized home exercise program. |
| ESWT + Sham PEMF | Sham comparator | Device: Sham Pulsed Electromagnetic Field Therapy, Device: Extracorporeal Shock Wave Therapy, Behavioral: Home Exercise ProgramParticipants will receive sham pulsed electromagnetic field therapy (PEMF) followed by the same extracorporeal shock wave therapy (ESWT) protocol once weekly for 5 weeks. The sham device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field. All participants will also receive the same standardized home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Symptom duration of at least 3 months
- Clinical diagnosis of unilateral lateral epicondylitis
- Numeric Rating Scale (NRS) pain score of at least 4
- Ability and willingness to provide written informed consent
Key exclusion criteria (14 listed)
- Injection treatment, including corticosteroid or platelet-rich plasma (PRP), within the previous 6 months
- Previous application of physical therapy modalities to the affected region
- Cervical radiculopathy, peripheral nerve entrapment neuropathy, or another neurological condition that may mimic lateral elbow pain
- Uncontrolled diabetes mellitus, defined as HbA1c >8%, or the presence of diabetic peripheral neuropathy
- Rheumatoid arthritis or other inflammatory rheumatic diseases
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 |
|---|---|---|
| Pulsed Electromagnetic Field TherapyAlso: PEMFActive pulsed electromagnetic field therapy will be applied before each ESWT session for 30 minutes, once weekly for 5 weeks. According to the study protocol, PEMF will be delivered at 25 Hz and 4.6 Hz sequentially, with a total of 6 mT per session. | Device | ESWT + Active PEMF |
| Sham Pulsed Electromagnetic Field TherapyAlso: Sham PEMFSham PEMF will be applied before ESWT using the same duration and positioning as active PEMF. The device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field. | Device | ESWT + Sham PEMF |
| Extracorporeal Shock Wave TherapyAlso: ESWTExtracorporeal shock wave therapy will be applied to the point of maximum tenderness over the lateral epicondyle using 2000 shocks per session at 1.5-2.0 bar and 10 Hz, once weekly for 5 weeks. Transmission gel will be used and local anesthesia will not be administered. | Device | ESWT + Active PEMF, ESWT + Sham PEMF |
| Home Exercise ProgramAll participants will receive the same standardized home exercise program. The program will include eccentric wrist extension (3 sets of 15 repetitions once daily), isometric wrist extension (3 sets of 30-second contractions once daily), and static stretching exercises targeting the forearm flexor and extensor muscle groups (3 sets of 30-second holds twice daily). The exercises will be demonstrated individually at the first session and supported with a written and visual exercise brochure. Exercise adherence will be checked and recorded weekly before each treatment session. | Behavioural | ESWT + Active PEMF, ESWT + Sham PEMF |
Primary outcome
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
The PRTEE is a lateral epicondylitis-specific questionnaire consisting of a pain subscale and a function subscale. The total score ranges from 0 to 100, with higher scores indicating greater pain and functional impairment.
Change in PRTEE Pain Subscale Score
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
The PRTEE pain subscale consists of 5 items and ranges from 0 to 50, with higher scores indicating greater pain.
Change in PRTEE Function Subscale Score
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
The PRTEE function subscale consists of 10 items and ranges from 0 to 50, with higher scores indicating greater functional impairment.
7 secondary outcomes
Change in Pain Intensity Measured by the Numeric Rating Scale
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Pressure Pain Threshold
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Maximum Grip Strength
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Pain-Free Grip Strength
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Common Extensor Tendon Thickness
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Common Extensor Tendon Hypoechogenicity
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
Change in Common Extensor Tendon Fibrillar Pattern
Time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion
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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been finalized and will be determined in accordance with ethical approval, participant consent, and the data-sharing requirements of the journal at the time of publication.
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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.
Ali Güneri, MD principal investigator
Gaziantep City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field Therapy, Extracorporeal Shock Wave Therapy and Home Exercise Program in people with Lateral Epicondylitis, run by Ali Güneri.
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 14 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Ali Güneri, MD (+90 507 751 20 47, draliguneri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score (time frame: Baseline, end of the 5-week treatment period, and 3 months after treatment completion). The study lists 3 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 3 Sep 2026.