Comparison of Two Different Splints in the Treatment of Lateral Epicondylitis

August 13, 2022 updated by: Banu Dilek, Dokuz Eylul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Izmir, Turkey, 35340
        • Recruiting
        • Dokuz Eylül University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kadir Songur, MD
        • Sub-Investigator:
          • Zehra Dinc Demir, MD
        • Sub-Investigator:
          • Caner Baysan, MD
        • Principal Investigator:
          • Banu Dilek, Assoc Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Lateral Epicondylitis 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.
Other Names:
  • Elbow Band
  • Counterforce Elbow Strap
  • Epicondylitis Bandage
  • Lateral Epicondyle Bandage
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.
Device: Wrist Extension 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.
Other Names:
  • Hand-wrist Resting Orthosis
  • Wrist Splint
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon
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.
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.
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.
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
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.
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.
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
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
All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week( of the treatment with ultrasonographic assessments.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.)
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.
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.)
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.
Functional disability will be measured by the Patient Rated Tennis Elbow Evaluation questionnaire. ( The best value = 0 , the worst value = 50.)
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.
Sensitivity will be measured by an algometer as the value at which the pain first appears.
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.
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.
All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Banu Dilek, Assoc Prof, Dokuz Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DokuzEUKadir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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