Comparison of Two Different Splints in the Treatment of Lateral Epicondylitis

NCT04773249 | Unknown

• 1 other identifier: DokuzEUKadir
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lateral Epicondylitis; Tennis Elbow

Keywords

ultrasonography; lateral epicondylitis bandage; wrist extension splint; wait-and-see policy; orthotic devices; forearm braces

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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

  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.

  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

  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

  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

  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

  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

  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

  All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.

Study Arms (3)

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.

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.

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.

Interventions

Lateral Epicondylitis Bandage DEVICE

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.

Also known as: Elbow Band, Counterforce Elbow Strap, Epicondylitis Bandage, Lateral Epicondyle Bandage

Lateral Epicondylitis Bandage

Wrist Extension Splint DEVICE

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.

Also known as: Hand-wrist Resting Orthosis, Wrist Splint

Wrist Extension Splint

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 38163530 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Banu Dilek, Assoc Prof

  Dokuz Eylul University

  STUDY CHAIR

Central Study Contacts

Banu Dilek, Assoc Prof

CONTACT

+905052248340; banu.dilek@deu.edu.tr

Kadir Songur, MD

CONTACT

+905054529231; kadir.93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Clinician)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 26, 2021
• Study Start: February 22, 2021
• Primary Completion: August 30, 2022
• Study Completion: September 6, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)