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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613922
• Other study ID #: TomrukDRF
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: May 2018

Study information

• Verified date: November 2018
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Early Manual Therapy
Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.
• Routine Physiotherapy
Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the function	Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)	postoperative week 6, 12.
Secondary	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.
Secondary	change in the range of motion (ROM)	ROM was assesed by using an universal goniometer	postoperative week 3, 6, 12.
Secondary	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.
Secondary	change in disability	Disability level was assesed by using Disabilities of Arm, Shoulder and Hand (DASH) questionnaire.	postoperative week 6, 12.