Clinical Trial: Low-level Laser Therapy on Wrist Fractures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-blind Placebo-controlled Study of Low-level Laser Therapy on Wrist Fractures

Brief Summary:

Approximately 15,000 persons in Norway suffer from a wrist fractures during a year, making it the most prevalent fracture in this country. Treated conservatively, a cast is used for 4-6 weeks before removal. After discontinuation of the cast, physiotherapy is implemented to aid in improving range of motion and regaining function of the injured wrist. The pain after injury can affect the patient to a greater or lesser extent, and it is common to prescribe sick leave for shorter amounts of time after the injury.

Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may reduce pain and swelling after acute trauma, and potentially promote healing. The aim of this study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks after injury.


Detailed Summary: Patients with wrist fractures are recruited from Bergen Municipal Emergency Ward, where they are randomly divided into two groups with concealed allocation. The fracture is immobilized with a cast of paris, with a small opening where Low Level Laser therapy can be administered in skin contact. The patients will receive treatment 3 times a week, for 3 weeks. After discontinuation of the cast, the patients swelling, pain, grip strength and function of the wrist is measured. The patients will meet for follow-up controls until 26 weeks after injury.
Sponsor: University of Bergen

Current Primary Outcome: Function [ Time Frame: 26 weeks ]

Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE)


Original Primary Outcome:

  • Active range of motion [ Time Frame: 26 weeks ]
    Active range of motion will be assessed using goniometer
  • Pain [ Time Frame: 26 weeks ]
    Pain will be assessed using a pain numerical rating scale from 0 to 10
  • Swelling [ Time Frame: 26 weeks ]
    Swelling will be assessed using measurement tape
  • Strength [ Time Frame: 26 weeks ]
    Strengt will be assessed using dynamometer


Current Secondary Outcome:

  • Pain [ Time Frame: 26 weeks ]
    Pressure Algometer
  • Swelling [ Time Frame: 26 weeks ]
    Swelling will be assessed using measurement tape
  • Active range of motion [ Time Frame: 26 weeks ]
    Active range of motion will be assessed using goniometer
  • Strength [ Time Frame: 26 weeks ]
    Strength will be assessed using dynamometer


Original Secondary Outcome: Function [ Time Frame: 26 weeks ]

Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE)


Information By: University of Bergen

Dates:
Date Received: April 21, 2016
Date Started: April 2016
Date Completion: September 2018
Last Updated: May 10, 2017
Last Verified: May 2017