Lateral EpicondylitisNCT06342518
ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation
A study testing Extracorporeal Shock Wave Therapy (ESWT) and Resting Splint , Exercises and ice in people with Lateral Epicondylitis and Tennis Elbow, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT) and Resting Splint , Exercises and ice
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Dec 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months
Who cannot join
- Patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, PRP, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732
About this study
Official title: Clinical and Sonographic Evaluation of the Effectiveness of Extracorporeal Shock Wave Therapy (ESWT) in Patients With Lateral Epicondylitis
This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.
Read the detailed description
42 patients with tennis elbow were split into two groups by chance: one group received shock wave therapy (ESWT), while the other received a fake treatment (Sham-ESWT) for comparison. Both groups underwent wrist exercises, splint usage, and ice application. Grip strength, pain levels, and how well they could move their wrist (functionality) were measured before, after, and one month post-treatment using tests. Additionally, the thickness of a common extensor tendon (CET) was evaluated using ultrasound. The patient, the doctor checking the patient, and the doctor doing the ultrasound didn't know which group the patient was in.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT), Sham ESWT, Resting Splint , Exercises and ice
- Keywords
- Extracorporeal Shock Wave Therapy (ESWT), sonographic assessment, Lateral epicondylitis
- 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)Device
The ESWT group received radial ESWT each session with a total of 2000 pulses at a frequency of 10 Hz. A gel was used at the interface, and the air pressure was set at 1.8 bar per session.
Sham ESWTDevice
The Sham-ESWT group received Sham radial ESWT each session, but without actual contact of the applicator. To enhance the illusion of treatment, gel was applied, and the device emitted sound at every shock
Resting Splint , Exercises and iceBehavioural
Ensuring proper usage of the wrist resting splint by the patient was confirmed during follow-up visits. The physician instructed the patients on stretching and strengthening exercises for wrist extensors, which they were asked to perform three times a day. Application of ice for 20 minutes every 3-4 hours during painful periods was recommended. During follow-up visits patients confirmed that they adherence to exercises and recommendations.
| Study group | Role | What they receive |
|---|---|---|
| ESWT GROUP | Experimental | The ESWT group received radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions.
A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT); Behavioral: Resting Splint , Exercises and ice |
| Sham-ESWT group | Sham comparator | The Sham-ESWT group received Sham radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions.
A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups. Receives: Device: Sham ESWT; Behavioral: Resting Splint , Exercises and ice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength
measured using the Jamar hand dynamometer
Measured: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
Pain severity
Visual Analog Scale (VAS) which was scored from 0 (no pain) to 10 (extremely severe).
Measured: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
Functionality
the Patient-Rated Tennis Elbow Evaluation (PRTEE)
The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:
- PAIN subscale (0 = no pain, 10 = worst imaginable) Pain - 5 items
- FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability).
Pain Score = Sum of the 5 pain items(out of 50) Best Score = 0, Worst Score =50 Function Score = Sum of the 10 function items, Divided by 2 (out of 50) Best Score = 0, Worst Score = 50
Computing the Total Score Total Score = Sum of pain + function scores Best Score = 0, Worst Score = 50 Best Score = 0, Worst Score = 100
Measured: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
Quality of life score
Short Form-12 (SF-12), Patients are provided with the SF-12 questionnaire, which consists of 12 questions covering physical and mental health domains.
The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
PCS mean score: 56,5 MSC mean score: 60.7 Scores above mean indicate a better-than-average health-related quality of life, while scores below mean suggest below-average health.
Measured: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
deep muscular tissue sensitivity
pain pressure threshold (PPT) Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle.
Measured: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
thickness of the common extensor tendon (CET)
During ultrasonography for LE, the elbow is positioned in 90 degrees of flexion and the wrist in pronation. The ultrasound probe is placed longitudinally on the radial surface of the elbow. And common extensor tendon thickness was measured sonographically.
Measured: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342518
- Sponsor's protocol ID
- MU ESWT
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Sonographic Evaluation of the Effectiveness of Extracorporeal Shock Wave Therapy (ESWT) in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06342518
- Acronym / sponsor ID
- MU ESWT
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- Extracorporeal Shock Wave Therapy (ESWT), sonographic assessment, Lateral epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Apr 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 check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.
Detailed description
42 patients with tennis elbow were split into two groups by chance: one group received shock wave therapy (ESWT), while the other received a fake treatment (Sham-ESWT) for comparison. Both groups underwent wrist exercises, splint usage, and ice application. Grip strength, pain levels, and how well they could move their wrist (functionality) were measured before, after, and one month post-treatment using tests. Additionally, the thickness of a common extensor tendon (CET) was evaluated using ultrasound. The patient, the doctor checking the patient, and the doctor doing the ultrasound didn't know which group the patient was in.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT GROUP | Experimental | Device: Extracorporeal Shock Wave Therapy (ESWT), Behavioral: Resting Splint , Exercises and iceThe ESWT group received radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups. |
| Sham-ESWT group | Sham comparator | Device: Sham ESWT, Behavioral: Resting Splint , Exercises and iceThe Sham-ESWT group received Sham radial ESWT on the painful lateral epicondyle once per week for a total of 3 sessions. A wrist resting splint, wrist extensor strengthening and stretching exercises, and ice treatment were administered to both groups. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months
Key exclusion criteria (1 listed)
- Patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, PRP, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,
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)The ESWT group received radial ESWT each session with a total of 2000 pulses at a frequency of 10 Hz. A gel was used at the interface, and the air pressure was set at 1.8 bar per session. | Device | ESWT GROUP |
| Sham ESWTThe Sham-ESWT group received Sham radial ESWT each session, but without actual contact of the applicator. To enhance the illusion of treatment, gel was applied, and the device emitted sound at every shock | Device | Sham-ESWT group |
| Resting Splint , Exercises and iceEnsuring proper usage of the wrist resting splint by the patient was confirmed during follow-up visits. The physician instructed the patients on stretching and strengthening exercises for wrist extensors, which they were asked to perform three times a day. Application of ice for 20 minutes every 3-4 hours during painful periods was recommended. During follow-up visits patients confirmed that they adherence to exercises and recommendations. | Behavioural | ESWT GROUP, Sham-ESWT group |
Primary outcome
Hand Grip Strength
Time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
measured using the Jamar hand dynamometer
Pain severity
Time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
Visual Analog Scale (VAS) which was scored from 0 (no pain) to 10 (extremely severe).
Functionality
Time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
the Patient-Rated Tennis Elbow Evaluation (PRTEE) The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability). Pain Score = Sum of the 5 pain items(out of 50) Best Score = 0, Worst Score =50 Function Score = Sum of the 10 function items, Divided by 2 (out of 50) Best Score = 0, Worst Score = 50 Computing the Total Score Total Score = Sum of pain + function scores Best Score = 0, Worst Score = 50 Best Score = 0, Worst Score = 100
Quality of life score
Time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
Short Form-12 (SF-12), Patients are provided with the SF-12 questionnaire, which consists of 12 questions covering physical and mental health domains. The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). PCS mean score: 56,5 MSC mean score: 60.7 Scores above mean indicate a better-than-average health-related quality of life, while scores below mean suggest below-average health.
deep muscular tissue sensitivity
Time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
pain pressure threshold (PPT) Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle.
thickness of the common extensor tendon (CET)
Time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)
During ultrasonography for LE, the elbow is positioned in 90 degrees of flexion and the wrist in pronation. The ultrasound probe is placed longitudinally on the radial surface of the elbow. And common extensor tendon thickness was measured sonographically.
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 2 Apr 2024.
- 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.
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 Extracorporeal Shock Wave Therapy (ESWT) and Resting Splint , Exercises and ice in people with Lateral Epicondylitis and Tennis Elbow, run by Istanbul Medeniyet 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 1 inclusion and 1 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 2 Apr 2024. 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. 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?
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?
Hand Grip Strength (time frame: Baseline, post-treatment(4th week), and one-month post-treatment (8th week)). The study lists 6 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 2 Apr 2024.