NCT05731869

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 9, 2023

Last Update Submit

February 9, 2023

Conditions

Keywords

surface electromyographymuscle activationorthosis

Outcome Measures

Primary Outcomes (1)

  • muscle activation

    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 Outcomes (2)

  • hand function

    one hour

  • satisfaction level

    one hour

Study Arms (3)

Control group

The group measured without the use of orthoses and tapes

Epicondylitis Band Group

Group measured with epicondylitis band

Other: epicondylitis band

Wrist Orthosis Group

Group measured with wrist orthosis

Other: wrist orhosis

Interventions

An off-the-shelf lateral epicondylitis tape in S-M-L dimensions was used distal to the lateral epicondylitis.

Epicondylitis Band Group

Wrist orthosis of the shelf was used in sizes S-M-L, covering the hand and wrist.

Wrist Orthosis Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals

You may qualify if:

  • Between 18-45 years old
  • Right upper extremity dominant
  • No upper extremity limitation in activities of daily living
  • Volunteer individuals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Sarı

Çankaya, Ankara, 06510, Turkey (Türkiye)

Location

Related Publications (1)

  • Sari M, Ozturk D, Bek N. Comparison of two different orthoses used in the treatment of lateral epicondylitis. Prosthet Orthot Int. 2025 Feb 1;49(1):127-132. doi: 10.1097/PXR.0000000000000345. Epub 2024 Mar 22.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 16, 2023

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

September 1, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations