Lateral EpicondylitisNCT07028840
Physiotherapy Applications in Lateral Epicondylitis
A study testing Physiotherapy, Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in people with Lateral Epicondylitis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) in improving pain, grip strength, and function in patients 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?
- Physiotherapy, Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2020to 30 Dec 2020
- 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
Who may be able to join
- Being over the age of 18,
- Being diagnosed with lateral epicondylitis,
- Not having received lateral epicondylitis treatment in the last 3 months
Who cannot join
- Stopping the treatment,
- Those who have been traumatized in the last 3 months,
- Those who use drugs that can affect muscle strength or pain level (muscle relaxants, analgesics, gabapentinoids, etc.)
- Those with open wounds in the elbow area, Those with elbow fractures, Those with drug allergies, Pregnant and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Extracorporeal Shockwave Therapy (ESWT) and High-intensity Laser Therapy (HILT) in Terms of Pain, Function and Grip Strength in Lateral Epicondilitis: a Randomized Controlled Study
This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) in improving pain, grip strength, and function in patients with lateral epicondylitis. A total of 42 volunteer patients aged 18-65 were enrolled at Balıkesir Private Sevgi Hospital physical medicine polyclinic. Participants were randomly assigned into three groups: group 1 received conventional physiotherapy, group 2 received physiotherapy plus ESWT, and group 3 received physiotherapy plus HILT. Physiotherapy was applied for 2 weeks, totaling 10 sessions. ESWT and HILT were each administered twice weekly for 2 weeks, totaling 4 sessions. Pain was measured using the visual analog scale (VAS), grip strength with a hand dynamometer, and function using the Duruöz Hand Index and PRTEE-T questionnaire. Evaluations were performed before treatment, after 2 weeks, and one month post-treatment.
Read the detailed description
This randomized controlled clinical trial investigates the effects of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) on pain, grip strength, and function in patients diagnosed with lateral epicondylitis. The study was conducted at the physical medicine polyclinic of Balıkesir Private Sevgi Hospital and included 42 patients aged 18 to 65 who were referred for therapeutic physical therapy after being diagnosed for the first time with lateral epicondylitis.
Participants were randomly divided into three groups:
Group 1: received conventional physiotherapy including hot pack application, transcutaneous electric nerve stimulation (TENS), and stretching/strengthening exercises. Physiotherapy was administered 5 times per week for 2 weeks (total of 10 sessions).
Group 2: received the same physiotherapy as group 1, plus extracorporeal shock wave therapy (ESWT) administered twice per week for 2 weeks (total of 4 sessions).
Group 3: received the same physiotherapy as group 1, plus high-intensity laser therapy (HILT) administered twice per week for 2 weeks (total of 4 sessions).
Pain severity was evaluated using the visual analog scale (VAS), grip strength using a hand dynamometer, and functional status using the Duruöz Hand Index and patient-rated tennis elbow evaluation (PRTEE-T). All outcome measures were assessed at three time points: baseline (before treatment), post-treatment (after 2 weeks), and at 1-month follow-up. The primary objective was to assess whether either ESWT or HILT offers additional benefit over standard physiotherapy and whether one modality is superior to the other in treating lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Physiotherapy, Extracorporeal Shock Wave Therapy (ESWT), High-Intensity Laser Therapy (HILT)
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
10 sessions over 2 weeks, including TENS, cold therapy, ultrasound, and exercise therapy, 5 sessions per week.
Extracorporeal Shock Wave Therapy (ESWT)Device
4 sessions total, applied 2 times per week for 2 weeks.
High-Intensity Laser Therapy (HILT)Device
4 sessions total, applied 2 times per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | This group received conventional physiotherapy only Receives: Other: Physiotherapy |
| Physiotherapy + ESWT | Active comparator | This group received conventional physiotherapy and additional extracorporeal shock wave therapy (ESWT) Receives: Other: Physiotherapy; Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Physiotherapy + HILT | Active comparator | This group received conventional physiotherapy and additional high-intensity laser therapy (HILT). Receives: Other: Physiotherapy; Device: High-Intensity Laser Therapy (HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity - Visual Analog Scale (VAS)
Pain intensity will be evaluated using the visual analog scale (VAS), a 10 cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Continuous scale (0-10), higher scores indicate worse outcome.
Measured: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
Grip Strength - Hand Dynamometer
Grip strength will be measured in kilograms using a hand dynamometer. Continuous scale, higher scores indicate better outcome
Measured: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
Upper Extremity Function - Duruöz Hand Index
The Duruöz Hand Index is a functional scale that assesses hand-related disability. Scores range from 0 to 90, with higher scores indicating worse functional impairment.
Measured: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
Functional Evaluation - PRTEE-T (Patient-Rated Tennis Elbow Evaluation)
The PRTEE-T is a 15-item patient-rated questionnaire for lateral epicondylitis. Total scores range from 0 (no disability) to 100 (maximum disability). Continuous scale (0-100), higher scores indicate worse outcome.
Measured: Baseline (Day 1), at the end of 2-week treatment, 4 weeks 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 posted19 Jun 2025
- Study start10 Jun 2020
- Primary completion5 Sep 2020
- Study completion30 Dec 2020
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suat EREL, Pamukkale University
- Investigators
- SUAT EREL, PROF.DR., Study director, PAMUKKALE UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028840
- Sponsor's protocol ID
- 674325
- Status last verified
- Jun 2025
- First submitted
- 7 Oct 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Extracorporeal Shockwave Therapy (ESWT) and High-intensity Laser Therapy (HILT) in Terms of Pain, Function and Grip Strength in Lateral Epicondilitis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07028840
- Acronym / sponsor ID
- 674325
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 19 Jun 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.
This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) in improving pain, grip strength, and function in patients with lateral epicondylitis. A total of 42 volunteer patients aged 18-65 were enrolled at Balıkesir Private Sevgi Hospital physical medicine polyclinic. Participants were randomly assigned into three groups: group 1 received conventional physiotherapy, group 2 received physiotherapy plus ESWT, and group 3 received physiotherapy plus HILT. Physiotherapy was applied for 2 weeks, totaling 10 sessions. ESWT and HILT were each administered twice weekly for 2 weeks, totaling 4 sessions. Pain was measured using the visual analog scale (VAS), grip strength with a hand dynamometer, and function using the Duruöz Hand Index and PRTEE-T questionnaire. Evaluations were performed before treatment, after 2 weeks, and one month post-treatment.
Detailed description
This randomized controlled clinical trial investigates the effects of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) on pain, grip strength, and function in patients diagnosed with lateral epicondylitis. The study was conducted at the physical medicine polyclinic of Balıkesir Private Sevgi Hospital and included 42 patients aged 18 to 65 who were referred for therapeutic physical therapy after being diagnosed for the first time with lateral epicondylitis.
Participants were randomly divided into three groups:
Group 1: received conventional physiotherapy including hot pack application, transcutaneous electric nerve stimulation (TENS), and stretching/strengthening exercises. Physiotherapy was administered 5 times per week for 2 weeks (total of 10 sessions).
Group 2: received the same physiotherapy as group 1, plus extracorporeal shock wave therapy (ESWT) administered twice per week for 2 weeks (total of 4 sessions).
Group 3: received the same physiotherapy as group 1, plus high-intensity laser therapy (HILT) administered twice per week for 2 weeks (total of 4 sessions).
Pain severity was evaluated using the visual analog scale (VAS), grip strength using a hand dynamometer, and functional status using the Duruöz Hand Index and patient-rated tennis elbow evaluation (PRTEE-T). All outcome measures were assessed at three time points: baseline (before treatment), post-treatment (after 2 weeks), and at 1-month follow-up. The primary objective was to assess whether either ESWT or HILT offers additional benefit over standard physiotherapy and whether one modality is superior to the other in treating lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Other: PhysiotherapyThis group received conventional physiotherapy only |
| Physiotherapy + ESWT | Active comparator | Other: Physiotherapy, Device: Extracorporeal Shock Wave Therapy (ESWT)This group received conventional physiotherapy and additional extracorporeal shock wave therapy (ESWT) |
| Physiotherapy + HILT | Active comparator | Other: Physiotherapy, Device: High-Intensity Laser Therapy (HILT)This group received conventional physiotherapy and additional high-intensity laser therapy (HILT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over the age of 18,
- Being diagnosed with lateral epicondylitis,
- Not having received lateral epicondylitis treatment in the last 3 months
Key exclusion criteria (4 listed)
- Stopping the treatment,
- Those who have been traumatized in the last 3 months,
- Those who use drugs that can affect muscle strength or pain level (muscle relaxants, analgesics, gabapentinoids, etc.)
- Those with open wounds in the elbow area, Those with elbow fractures, Those with drug allergies, Pregnant and breastfeeding women.
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 |
|---|---|---|
| Physiotherapy10 sessions over 2 weeks, including TENS, cold therapy, ultrasound, and exercise therapy, 5 sessions per week. | Other | Physiotherapy, Physiotherapy + ESWT, Physiotherapy + HILT |
| Extracorporeal Shock Wave Therapy (ESWT)4 sessions total, applied 2 times per week for 2 weeks. | Device | Physiotherapy + ESWT |
| High-Intensity Laser Therapy (HILT)4 sessions total, applied 2 times per week for 2 weeks. | Device | Physiotherapy + HILT |
Primary outcome
Pain Severity - Visual Analog Scale (VAS)
Time frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
Pain intensity will be evaluated using the visual analog scale (VAS), a 10 cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Continuous scale (0-10), higher scores indicate worse outcome.
Grip Strength - Hand Dynamometer
Time frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
Grip strength will be measured in kilograms using a hand dynamometer. Continuous scale, higher scores indicate better outcome
Upper Extremity Function - Duruöz Hand Index
Time frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
The Duruöz Hand Index is a functional scale that assesses hand-related disability. Scores range from 0 to 90, with higher scores indicating worse functional impairment.
Functional Evaluation - PRTEE-T (Patient-Rated Tennis Elbow Evaluation)
Time frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion
The PRTEE-T is a 15-item patient-rated questionnaire for lateral epicondylitis. Total scores range from 0 (no disability) to 100 (maximum disability). Continuous scale (0-100), higher scores indicate worse outcome.
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 25 Jun 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Lateral Epicondylitis
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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.
SUAT EREL, PROF.DR. study director
PAMUKKALE UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy, Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in people with Lateral Epicondylitis, run by Pamukkale 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 3 inclusion and 4 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 25 Jun 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?
Pain Severity - Visual Analog Scale (VAS) (time frame: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion). The study lists 4 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 25 Jun 2025.