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Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures

Primary Purpose

Distal Radius Fracture

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Early Manual Therapy

Routine Physiotherapy

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring manual therapy, radius fracture, function, disability, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

An age of eighteen years or older
An unstable fracture of the distal end of the radius
Fixation with a volar locking plate
Able to read, write, and understand Turkish
Willing and able to attend the study

Exclusion Criteria:

Previous fracture on the injured side
Concurrent fracture in contralateral upper extremity
Accompanied bony and soft tissue injuries other than radius fracture
Inflammatory joint diseases, metabolic diseases and neurological diseases
Mental and cognitive disorders that would seriously affect cooperation

Sites / Locations

Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Manual Therapy Group

Routine Physiotherapy Group

Arm Description

Routine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied.

Only routine physiotherapy program was applied

Outcomes

Primary Outcome Measures

change in the function

Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)

Secondary Outcome Measures

change in the severity of pain

Severity of pain was assessed by using Visual Analogue Scale (VAS), which ranges between 0-10 points, 0 represents no pain and 10 denotes maximum pain intensity.

change in the range of motion (ROM)

ROM was assesed by using an universal goniometer

change in hand and pinch grip strength

hand and pinch grip strength was assesed by using hydrolic hand and finger dynamometers.

change in disability

Disability level was assesed by using Disabilities of Arm, Shoulder and Hand (DASH) questionnaire.

Full Information

NCT ID

NCT03613922

First Posted

July 26, 2018

Last Updated

November 12, 2018

Sponsor

Dokuz Eylul University

1. Study Identification

Unique Protocol Identification Number

NCT03613922

Brief Title

Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures

Official Title

Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

September 2015 (Actual)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study was to investigate the effects of early manual therapy on function, pain, range of motion (ROM), hand and pinch grip strength and disability level in patients underwent volar plating after distal radius fracture (DRF). Patients were randomly divided into two groups: Routin Physiotherapy (RP) or Early Manual Therapy (EMT). While RP group received routine physiotherapy, EMT group received routine physiotherapy plus Mulligan's Mobilization With Movement technique. All treatments were done two sessions a week, through 12 weeks. Function, pain, range of motion (ROM), hand and pinch grip strength and disability level of patients were assessed. Measurements were made at postoperative week 3, 6 and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distal Radius Fracture

Keywords

manual therapy, radius fracture, function, disability, physiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Manual Therapy Group

Arm Type

Experimental

Arm Description

Routine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied.

Arm Title

Routine Physiotherapy Group

Arm Type

Active Comparator

Arm Description

Only routine physiotherapy program was applied

Intervention Type

Other

Intervention Name(s)

Early Manual Therapy

Intervention Description

Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.

Intervention Type

Other

Intervention Name(s)

Routine Physiotherapy

Intervention Description

Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.

Primary Outcome Measure Information:

Title

change in the function

Description

Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)

Time Frame

postoperative week 6, 12.

Secondary Outcome Measure Information:

Title

change in the severity of pain

Description

Severity of pain was assessed by using Visual Analogue Scale (VAS), which ranges between 0-10 points, 0 represents no pain and 10 denotes maximum pain intensity.

Time Frame

postoperative day 1, postoperative week 3, 6, 12.

Title

change in the range of motion (ROM)

Description

ROM was assesed by using an universal goniometer

Time Frame

postoperative week 3, 6, 12.

Title

change in hand and pinch grip strength

Description

hand and pinch grip strength was assesed by using hydrolic hand and finger dynamometers.

Time Frame

postoperative week 3, 6, 12.

Title

change in disability

Description

Disability level was assesed by using Disabilities of Arm, Shoulder and Hand (DASH) questionnaire.

Time Frame

postoperative week 6, 12.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: An age of eighteen years or older An unstable fracture of the distal end of the radius Fixation with a volar locking plate Able to read, write, and understand Turkish Willing and able to attend the study Exclusion Criteria: Previous fracture on the injured side Concurrent fracture in contralateral upper extremity Accompanied bony and soft tissue injuries other than radius fracture Inflammatory joint diseases, metabolic diseases and neurological diseases Mental and cognitive disorders that would seriously affect cooperation

Facility Information:

Facility Name

Dokuz Eylul University

City

Izmir

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures

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