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Completed

NCT Number: NCT03613922

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Forearm Injuries Fractures, Bone Radius Fractures Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Manual Therapy

Other

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

Routine physiotherapy

Other

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

Primary outcomes

  1. change in the function

    Time frame: postoperative week 6, 12.

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

Secondary outcomes

  1. change in the severity of pain

    Time frame: postoperative day 1, postoperative week 3, 6, 12.

    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.

  2. change in the range of motion (ROM)

    Time frame: postoperative week 3, 6, 12.

    ROM was assesed by using an universal goniometer

  3. change in hand and pinch grip strength

    Time frame: postoperative week 3, 6, 12.

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

  4. change in disability

    Time frame: postoperative week 6, 12.

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

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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