- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773249
Comparison of Two Different Splints in the Treatment of Lateral Epicondylitis
Comparison of Clinical and Ultrasonographic Efficacy of Two Different Splints Used in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Banu Dilek, Assoc Prof
- Phone Number: +905052248340
- Email: banu.dilek@deu.edu.tr
Study Contact Backup
- Name: Kadir Songur, MD
- Phone Number: +905054529231
- Email: kadir.93@gmail.com
Study Locations
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Izmir, Turkey, 35340
- Recruiting
- Dokuz Eylul University
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Contact:
- Banu Dilek, Assoc Prof
- Phone Number: +905052248340
- Email: banu.dilek@deu.edu.tr
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Contact:
- Kadir Songur, MD
- Phone Number: +905054529231
- Email: kadir.93@gmail.com
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Principal Investigator:
- Kadir Songur, MD
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Sub-Investigator:
- Zehra Dinc Demir, MD
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Sub-Investigator:
- Caner Baysan, MD
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Principal Investigator:
- Banu Dilek, Assoc Prof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lateral Epicondylitis Bandage
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.
|
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.
Other Names:
|
Experimental: Wrist Extension Splint
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.
|
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.
Other Names:
|
No Intervention: Wait-and-see Policy
These patients will be monitored with a wait-and-see policy.
No splint or band will be given to the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic measurements.
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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.
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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.
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
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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.
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The assessment of heterogeneity of the common extensor tendon, Grade 1 = presence, Grade 0 = absence
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
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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.
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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.
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
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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.
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The assessment of bone abnormality of the lateral epicondyle, Grade 1 = presence, Grade 0 = absence
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week( of the treatment with ultrasonographic assessments.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.)
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
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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.
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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.)
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
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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.
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Functional disability will be measured by the Patient Rated Tennis Elbow Evaluation questionnaire.
( The best value = 0 , the worst value = 50.)
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
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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.
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Sensitivity will be measured by an algometer as the value at which the pain first appears.
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
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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.
|
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.
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All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Banu Dilek, Assoc Prof, Dokuz Eylul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEUKadir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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