- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05731869
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis
February 9, 2023 updated by: Ankara Yildirim Beyazıt University
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis on Extensor Muscle Activity and Upper Extremity Functions
Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis.
Injury of these muscles is seen as lateral epicondylitis in the clinic.
Physiotherapy techniques are frequently applied in the management of diseases related to forearm extensor muscles such as lateral epicondylitis.
Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic extensor brace are used for this.
Studies have been conducted on pain, hand function and orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of studies investigating the effects on muscle activation is insufficient.Therefore, the aim of the study is to examine the effects of different types of orthoses used for the forearm extensor group on extensor muscle activation and upper limb functions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Çankaya, Ankara, Turkey, 06510
- Mustafa Sarı
-
-
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
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy individuals
Description
Inclusion Criteria:
- Between 18-45 years old
- Right upper extremity dominant
- No upper extremity limitation in activities of daily living
- Volunteer individuals
Exclusion Criteria:
- With orthopedic, neurological and rheumatological problems in the upper extremity
- Entrapment neuropathy, TOS, cervical radiculopathy, and cervical disc herniation
- History of upper extremity injury or surgery in the last 6 months
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
The group measured without the use of orthoses and tapes
|
|
Epicondylitis Band Group
Group measured with epicondylitis band
|
An off-the-shelf lateral epicondylitis tape in S-M-L dimensions was used distal to the lateral epicondylitis.
|
Wrist Orthosis Group
Group measured with wrist orthosis
|
Wrist orthosis of the shelf was used in sizes S-M-L, covering the hand and wrist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle activation
Time Frame: one hour
|
A superficial EMG system will be used to measure signals from the extensor carpi radialis longus/brevis and extensor carpi digitorum communis muscles.Electrodes will be placed according to SENIAM criteria.The signals received from the muscles of the individuals will be recorded during grasping.
As a result, the average muscle activations of the muscles during the activity will be numerically recorded in %MVIC.
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hand function
Time Frame: one hour
|
Jebson Taylor Hand Function Test, which includes daily life activities (writing, eating, etc.) and consists of 7 sub-parameters, was applied to measure hand function.
The score is recorded in seconds and the score gets worse as the second increases.
|
one hour
|
satisfaction level
Time Frame: one hour
|
The OPUS questionnaire was used to measure the participants' orthotic satisfaction.
The OPUS questionnaire evaluates the weight, durability, aesthetics, ease of putting on, skin and clothing problems, comfort, and the pain-reducing effect of the orthosis associated with the orthosis.
The higher the score, the higher the level of satisfaction.
|
one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 1, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
February 9, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (Actual)
February 16, 2023
Study Record Updates
Last Update Posted (Actual)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2021/058
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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