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Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study

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What is being tested

Clavicular brace

Device
Who is being recruted

From 18 to 75 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorPrince of Songkla University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2022

Actual date on which the first participant was enrolled.

This study focuses on finding the best way to treat midshaft clavicle fractures, which are breaks in the collarbone. It compares two types of braces: a standard clavicular brace and a self-adjustable clavicular brace. The study includes ten adult patients aged between 18 and 75. Understanding which brace is more effective can help improve healing and comfort for people with this common type of fracture. By comparing these braces, the study aims to see if one type offers better results in terms of functionality, pain relief, and overall satisfaction during recovery. Participants in the study are divided into two groups. One group uses the standard clavicular brace, while the other uses the self-adjustable version. Each participant attends follow-up appointments over three months at regular intervals to monitor progress. The study evaluates the results by looking at various factors such as clinical improvements, pain levels, the amount of pain medication needed, and overall satisfaction. These are measured through different questionnaires and tests, including the DASH questionnaire for disability and pain scales like the Visual Analogue Scale (VAS). The study aims to determine which brace allows for better movement and comfort, as well as how quickly the bone heals.

Official TitleEfficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
Principal SponsorPrince of Songkla University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Patient with aged between 18 - 75 years old

Closed isolated fracture midshaft of clavicle within 9 days after the injury date

10 exclusion criteria prevent from participating
After bracing, fracture displacement and/or shortening > 2 cm or fracture comminution > 3 fragments

Segmental fracture

Open fracture

Impending open fracture (soft tissue compromise/skin lesion)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Prince of Songkla University

Songkhla, ThailandOpen Prince of Songkla University in Google Maps
Recruiting
One Study Center