Lateral EpicondylitisNCT04773249
Comparison of Two Different Splints in the Treatment of Lateral Epicondylitis
A study testing Lateral Epicondylitis Bandage and Wrist Extension Splint in people with Lateral Epicondylitis and Tennis Elbow, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis (LE) or tennis elbow; is the most common cause of lateral pain in the elbow, with an incidence of 1-3% in the general population. It is thought to develop as a result of overuse inflammation of the wrist joint extensor tendons, originating from the lateral epicondyle of the humerus. 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?
- Lateral Epicondylitis Bandage and Wrist Extension Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2021to 6 Sep 2022
- 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
- Applying to Dokuz Eylül University Medical Faculty Physical Medicine and Rehabilitation Department outpatient clinic
- Having pain in the elbow for less than 12 weeks and having no similar attack history for 1 year
- Diagnosing lateral epicondylitis with clinical and ultrasonographic evaluation
- Having pain of at least 3 in their VAS scores
- Agreeing to participate in the study
Who cannot join
- Having elbow pain for more than 12 weeks
- Having signs of lateral epicondylitis in the other extremity
- Having a history of injection for lateral epicondylitis
- In the last 3 months, who had physical therapy for lateral epicondylitis
- Having a history of elbow surgery and fracture in the elbow area.
- Having muscle weakness in the upper extremity due to cervical radiculopathy and/or entrapment neuropathy
- Having malignancy or neurological, rheumatological, and psychiatric disease comorbidities
- Pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University
Izmir, 35340
Banu Dilek, Assoc Prof, +905052248340, banu.dilek@deu.edu.tr
Kadir Songur, MD, +905054529231, kadir.93@gmail.com
About this study
Official title: Comparison of Clinical and Ultrasonographic Efficacy of Two Different Splints Used in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
Lateral epicondylitis (LE) or tennis elbow; is the most common cause of lateral pain in the elbow, with an incidence of 1-3% in the general population. It is thought to develop as a result of overuse inflammation of the wrist joint extensor tendons, originating from the lateral epicondyle of the humerus. The most common symptom is the pain located in the lateral aspect of the elbow, which can spread across the forearm extensor face and is aggravated by wrist extension, forearm supination, and strong grip movements of the hand. The diagnosis is made by clinical and ultrasonographic evaluations. Significant correlations were found between clinical symptoms of LE and increased joint extensor tendon thickness, focal hypoechogenicity, intratendinous calcification, bone abnormality, and diffuse heterogeneity findings that can be monitored by diagnostic ultrasound. Wait-see policy, conservative treatment regimens, local injections, and surgical approaches are the treatment methods that can be used on a patient-based basis until today. Conservative treatment options include physical therapy modalities such as exercise, massage, laser, electrotherapy, therapeutic ultrasound, extracorporeal shock wave therapy, the use of various splints, ice application, activity modification, rest, NSAIDs, and taping methods. The two prominent bracing methods are the lateral epicondylitis band and the wrist extension splint. Although these two methods are frequently used in daily practice, the limitations of studies investigating the effectiveness of orthoses and which orthosis are more effective draw attention. In comparative studies, some factors may affect clinical results such as allowing patients to use NSAIDs when necessary and organizing a home exercise program. Besides, none of them included a control group and the patients were not evaluated by ultrasonography. This study aims to compare the effects of the use of two different splints (lateral epicondylitis band and wrist extension splint) on clinical and ultrasonographic parameters in patients with a diagnosis of lateral epicondylitis.
Read the detailed description
The study is randomized and controlled. 158 patients will be included in to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of elbow pain, aged between 18-65 years and diagnosed with lateral epicondylitis by clinical and ultrasonographic methods. These patients will be divided into three groups randomly (group1 n:53, group 2 n:53, group 3 n:52).
First group: A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will also be asked to repeat this application while wearing the band.
Second group: A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements.
Third group: These patients will be monitored with a wait-and-see policy. No splint or band will be given to the patient.
Before treatment, age, gender, occupation, body mass index, duration of symptoms, trauma history, dominant hand, side of the symptom and previous similar complaint history will be questioned in all three groups.
All of the patients will be asked not to lift heavy for 6 weeks, to use their splints throughout the day, and to remove them during bathing and sleeping. Throughout the study, all patients will be allowed to take only paracetamol oral tablets as pain relief if needed and will be asked to keep a medication diary.
All patients will be evaluated 3 times, before the treatment, in the 3rd week during the treatment process, and in the 6th week after the treatment with a visual analog scale, patient-rated tennis elbow evaluation questionnaire, hand dynamometer, and ultrasonographic measurements. All evaluations will be done blindly by the clinician.
The primary aim of this randomized controlled single-blind study is to compare the effects of lateral epicondylitis bandage and wrist extension splint treatment on ultrasonographic changes in patients with lateral epicondylitis. Ultrasonographic evaluations will include measurement of maximum tendon thickness and assessment of hypoechogenicity, heterogeneity, neovascularity, and bone abnormality. The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon will be measured for both upper extremities.
The secondary aim is to compare the effects of these two different splint treatments on clinical changes such as pain, functional disability, sensitivity, and handgrip strength. Pain and functional disability will be measured by the Visual Analog Scale and Patient Rated Tennis Elbow Evaluation questionnaire, the sensitivity will be measured by algometer, and handgrip strength will be measured by hydraulic hand dynamometer for both hands.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Lateral Epicondylitis Bandage, Wrist Extension Splint
- Keywords
- ultrasonography, lateral epicondylitis bandage, wrist extension splint, wait-and-see policy, orthotic devices, forearm braces
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Epicondylitis BandageDevice
Also called Elbow Band, Counterforce Elbow Strap, Epicondylitis Bandage, Lateral Epicondyle Bandage
The lateral epicondylitis bandage was first used by Ilfeld in 1965, and it is a non-elastic band that prevents the expansion of the muscles in the proximal forearm. A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will be asked to repeat this application while wearing the band. The patients will also be asked to use the bandage throughout the day, and to remove them during bathing and sleeping.
Wrist Extension SplintDevice
Also called Hand-wrist Resting Orthosis, Wrist Splint
Wrist extension splint is an upper extremity orthosis that keeps the wrist at 15-20 degrees of extension with the polyethylene bar it contains. A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements. The patients will be asked to use the splint throughout the day, and to remove them during bathing and sleeping.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Epicondylitis Bandage | Experimental | A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will be asked to repeat this application while wearing the band. The patients will also be asked to use the bandage throughout the day, and to remove them during bathing and sleeping. Receives: Device: Lateral Epicondylitis Bandage |
| Wrist Extension Splint | Experimental | A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements. The patients will be asked to use the splint throughout the day, and to remove them during bathing and sleeping. Receives: Device: Wrist Extension Splint |
| Wait-and-see Policy | No intervention | These patients will be monitored with a wait-and-see policy. No splint or band will be given to the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the maximum tendon thickness of the common extensor tendon via ultrasonographic measurement
The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic measurements.
Change of the hypoechogenicity of the common extensor tendon via ultrasonographic assessment.
The assessment of hypoechogenicity of the common extensor tendon, Grade 0: Normal fibrillar and hypoechoic structure, Grade 1: hypoechoic lesions affecting less than 30% of whole section of the tendon, Grade 2: hypoechoic lesions affecting more than 30% and less than 50% of the whole section of the tendon, Grade 3: single large or multiple hypoechoic lesions affecting more than 50% of the whole section of the tendon / high-grade tendinosis.
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
Change of the heterogeneity of the common extensor tendon via ultrasonographic assessment.
The assessment of heterogeneity of the common extensor tendon, Grade 1 = presence, Grade 0 = absence
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
Change of the neovascularity of the common extensor tendon via ultrasonographic assessment.
The assessment of neovascularity of the common extensor tendon, Grade 0 = no detectable neovessels Grade 1 = neovessels detected in less than 30% of the whole section of the tendon Grade 2 = neovessels detected in more than 30% but less than 50% of the whole section of the tendon Grade 3 = neovessels detected in more than 50% of the whole section of the tendon.
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
Change of the bone abnormality of the lateral epicondyle via ultrasonographic assessment
The assessment of bone abnormality of the lateral epicondyle, Grade 1 = presence, Grade 0 = absence
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week( of the treatment with ultrasonographic assessments.
Secondary outcomes (5)
Change of the pain on the lateral elbow via Visual Analog Scale
The pain during rest, night, and daily life activities will be measured with a Visual Analog Scale (Minimum value : 0 , Maximum value: 100, A higher score indicates greater pain intensity.)
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the pain on the lateral elbow via Patient Rated Tennis Elbow Evaluation
The pain will be also measured by the Patient Rated Tennis Elbow Evaluation questionnaire.(which describe the pain on a scale from 0 to 10 for each of the 5 different questions. A higher score indicates greater pain intensity.)
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the functional disability via Patient Rated Tennis Elbow Evaluation
Functional disability will be measured by the Patient Rated Tennis Elbow Evaluation questionnaire. ( The best value = 0 , the worst value = 50.)
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the sensitivity via algometer
Sensitivity will be measured by an algometer as the value at which the pain first appears.
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the handgrip strength via hand dynamometer
Handgrip strength will be measured by a hydraulic hand dynamometer. Average values will be determined by making 3 separate measurements for both hands, and 30-second rest periods will be given between measurements.
Measured: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start22 Feb 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion6 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Dilek, Dokuz Eylul University
- Investigators
- Banu Dilek, Assoc Prof, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773249
- Sponsor's protocol ID
- DokuzEUKadir
- Status last verified
- Aug 2022
- First submitted
- 21 Feb 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Songur K, Demir ZD, Baysan C, Dilek B. Clinical and Ultrasonographic Effectiveness of Two Different Splints Used for the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study. Arch Phys Med Rehabil. 2024 Apr;105(4):655-663. doi: 10.1016/j.apmr.2023.12.010. Epub 2023 Dec 30.
PubMed 38163530
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Ultrasonographic Efficacy of Two Different Splints Used in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04773249
- Acronym / sponsor ID
- DokuzEUKadir
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- ultrasonography, lateral epicondylitis bandage, wrist extension splint, wait-and-see policy, orthotic devices, forearm braces
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 6 Sep 2022 (estimated)
- First posted
- 26 Feb 2021 (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.
Lateral epicondylitis (LE) or tennis elbow; is the most common cause of lateral pain in the elbow, with an incidence of 1-3% in the general population. It is thought to develop as a result of overuse inflammation of the wrist joint extensor tendons, originating from the lateral epicondyle of the humerus. The most common symptom is the pain located in the lateral aspect of the elbow, which can spread across the forearm extensor face and is aggravated by wrist extension, forearm supination, and strong grip movements of the hand. The diagnosis is made by clinical and ultrasonographic evaluations. Significant correlations were found between clinical symptoms of LE and increased joint extensor tendon thickness, focal hypoechogenicity, intratendinous calcification, bone abnormality, and diffuse heterogeneity findings that can be monitored by diagnostic ultrasound. Wait-see policy, conservative treatment regimens, local injections, and surgical approaches are the treatment methods that can be used on a patient-based basis until today. Conservative treatment options include physical therapy modalities such as exercise, massage, laser, electrotherapy, therapeutic ultrasound, extracorporeal shock wave therapy, the use of various splints, ice application, activity modification, rest, NSAIDs, and taping methods. The two prominent bracing methods are the lateral epicondylitis band and the wrist extension splint. Although these two methods are frequently used in daily practice, the limitations of studies investigating the effectiveness of orthoses and which orthosis are more effective draw attention. In comparative studies, some factors may affect clinical results such as allowing patients to use NSAIDs when necessary and organizing a home exercise program. Besides, none of them included a control group and the patients were not evaluated by ultrasonography. This study aims to compare the effects of the use of two different splints (lateral epicondylitis band and wrist extension splint) on clinical and ultrasonographic parameters in patients with a diagnosis of lateral epicondylitis.
Detailed description
The study is randomized and controlled. 158 patients will be included in to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of elbow pain, aged between 18-65 years and diagnosed with lateral epicondylitis by clinical and ultrasonographic methods. These patients will be divided into three groups randomly (group1 n:53, group 2 n:53, group 3 n:52).
First group: A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will also be asked to repeat this application while wearing the band.
Second group: A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements.
Third group: These patients will be monitored with a wait-and-see policy. No splint or band will be given to the patient.
Before treatment, age, gender, occupation, body mass index, duration of symptoms, trauma history, dominant hand, side of the symptom and previous similar complaint history will be questioned in all three groups.
All of the patients will be asked not to lift heavy for 6 weeks, to use their splints throughout the day, and to remove them during bathing and sleeping. Throughout the study, all patients will be allowed to take only paracetamol oral tablets as pain relief if needed and will be asked to keep a medication diary.
All patients will be evaluated 3 times, before the treatment, in the 3rd week during the treatment process, and in the 6th week after the treatment with a visual analog scale, patient-rated tennis elbow evaluation questionnaire, hand dynamometer, and ultrasonographic measurements. All evaluations will be done blindly by the clinician.
The primary aim of this randomized controlled single-blind study is to compare the effects of lateral epicondylitis bandage and wrist extension splint treatment on ultrasonographic changes in patients with lateral epicondylitis. Ultrasonographic evaluations will include measurement of maximum tendon thickness and assessment of hypoechogenicity, heterogeneity, neovascularity, and bone abnormality. The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon will be measured for both upper extremities.
The secondary aim is to compare the effects of these two different splint treatments on clinical changes such as pain, functional disability, sensitivity, and handgrip strength. Pain and functional disability will be measured by the Visual Analog Scale and Patient Rated Tennis Elbow Evaluation questionnaire, the sensitivity will be measured by algometer, and handgrip strength will be measured by hydraulic hand dynamometer for both hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Lateral Epicondylitis Bandage | Experimental | Device: Lateral Epicondylitis BandageA lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will be asked to repeat this application while wearing the band. The patients will also be asked to use the bandage throughout the day, and to remove them during bathing and sleeping. |
| Wrist Extension Splint | Experimental | Device: Wrist Extension SplintA wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements. The patients will be asked to use the splint throughout the day, and to remove them during bathing and sleeping. |
| Wait-and-see Policy | No intervention | –These patients will be monitored with a wait-and-see policy. No splint or band will be given to the patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Applying to Dokuz Eylül University Medical Faculty Physical Medicine and Rehabilitation Department outpatient clinic
- Having pain in the elbow for less than 12 weeks and having no similar attack history for 1 year
- Diagnosing lateral epicondylitis with clinical and ultrasonographic evaluation
- Having pain of at least 3 in their VAS scores
- Agreeing to participate in the study
Key exclusion criteria (8 listed)
- Having elbow pain for more than 12 weeks
- Having signs of lateral epicondylitis in the other extremity
- Having a history of injection for lateral epicondylitis
- In the last 3 months, who had physical therapy for lateral epicondylitis
- Having a history of elbow surgery and fracture in the elbow area.
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 |
|---|---|---|
| Lateral Epicondylitis BandageAlso: Elbow Band, Counterforce Elbow Strap, Epicondylitis Bandage, Lateral Epicondyle BandageThe lateral epicondylitis bandage was first used by Ilfeld in 1965, and it is a non-elastic band that prevents the expansion of the muscles in the proximal forearm. A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will be asked to repeat this application while wearing the band. The patients will also be asked to use the bandage throughout the day, and to remove them during bathing and sleeping. | Device | Lateral Epicondylitis Bandage |
| Wrist Extension SplintAlso: Hand-wrist Resting Orthosis, Wrist SplintWrist extension splint is an upper extremity orthosis that keeps the wrist at 15-20 degrees of extension with the polyethylene bar it contains. A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements. The patients will be asked to use the splint throughout the day, and to remove them during bathing and sleeping. | Device | Wrist Extension Splint |
Primary outcome
Change of the maximum tendon thickness of the common extensor tendon via ultrasonographic measurement
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic measurements.
The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon
Change of the hypoechogenicity of the common extensor tendon via ultrasonographic assessment.
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
The assessment of hypoechogenicity of the common extensor tendon, Grade 0: Normal fibrillar and hypoechoic structure, Grade 1: hypoechoic lesions affecting less than 30% of whole section of the tendon, Grade 2: hypoechoic lesions affecting more than 30% and less than 50% of the whole section of the tendon, Grade 3: single large or multiple hypoechoic lesions affecting more than 50% of the whole section of the tendon / high-grade tendinosis.
Change of the heterogeneity of the common extensor tendon via ultrasonographic assessment.
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
The assessment of heterogeneity of the common extensor tendon, Grade 1 = presence, Grade 0 = absence
Change of the neovascularity of the common extensor tendon via ultrasonographic assessment.
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
The assessment of neovascularity of the common extensor tendon, Grade 0 = no detectable neovessels Grade 1 = neovessels detected in less than 30% of the whole section of the tendon Grade 2 = neovessels detected in more than 30% but less than 50% of the whole section of the tendon Grade 3 = neovessels detected in more than 50% of the whole section of the tendon.
Change of the bone abnormality of the lateral epicondyle via ultrasonographic assessment
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week( of the treatment with ultrasonographic assessments.
The assessment of bone abnormality of the lateral epicondyle, Grade 1 = presence, Grade 0 = absence
5 secondary outcomes
Change of the pain on the lateral elbow via Visual Analog Scale
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the pain on the lateral elbow via Patient Rated Tennis Elbow Evaluation
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the functional disability via Patient Rated Tennis Elbow Evaluation
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the sensitivity via algometer
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Change of the handgrip strength via hand dynamometer
Time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 38163530Songur K, Demir ZD, Baysan C, Dilek B. Clinical and Ultrasonographic Effectiveness of Two Different Splints Used for the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study. Arch Phys Med Rehabil. 2024 Apr;105(4):655-663. doi: 10.1016/j.apmr.2023.12.010. Epub 2023 Dec 30.
- 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.
Banu Dilek, Assoc Prof study chair
Dokuz Eylul 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 Lateral Epicondylitis Bandage and Wrist Extension Splint in people with Lateral Epicondylitis and Tennis Elbow, run by Dokuz Eylul 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 8 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banu Dilek, Assoc Prof (+905052248340, banu.dilek@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the maximum tendon thickness of the common extensor tendon via ultrasonographic measurement (time frame: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic measurements.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773249, which also lists 1 linked publication.
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 Aug 2022.