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

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Early Manual Therapy; Other: Routine Physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Dokuz Eylul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Manual Therapy Group; Routine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied.	Other: Early Manual Therapy; Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.; Other: Routine Physiotherapy; Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.
Active Comparator: Routine Physiotherapy Group; Only routine physiotherapy program was applied	Other: Routine Physiotherapy; Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the function	Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)	postoperative week 6, 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	postoperative day 1, postoperative week 3, 6, 12.
change in the range of motion (ROM)	ROM was assesed by using an universal goniometer	postoperative week 3, 6, 12.
change in hand and pinch grip strength	hand and pinch grip strength was assesed by using hydrolic hand and finger dynamometers.	postoperative week 3, 6, 12.
change in disability	Disability level was assesed by using Disabilities of Arm, Shoulder and Hand (DASH) questionnaire.	postoperative week 6, 12.

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: function; manual therapy; physiotherapy; disability; radius fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: TomrukDRF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No