Skip to main content
OpenTrials
Completed

NCT Number: NCT02749929

Low-level Laser Therapy in Wrist Fractures

Approximately 15,000 persons in Norway suffer from 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colles' Fracture Arm Injuries Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases 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

Bergen Accident Emergency Hospital

Bergen, Norway

About this study

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, 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with distal radiusfraktur, with or without ulna fracture Colles' fracture
  • The breach must be closed
  • Under 10 degrees dorsal displacement of radius
  • Under 5mm shortening of the radius
  • Under 3 mm step in the joint
  • 18+ years

Exclusion criteria

  • People who do not speak Norwegian or English
  • If the patient is pregnant
  • Patient with Smith fracture
  • Wounds over fracture area
  • If the patient have a peripheral nerve injury
  • If the patient had (previously) operated wrist
  • Persons with verified osteoporosis at the time of injury, systemic inflammatory disease (rheumatism), mental illness, stroke, Parkinson's disease, multiple sclerosis, cancer or congenital malformations in wrist
  • If the laser treatment can not be started within 3 days after fracture

Treatment and study plan

Low Level Laser Therapy

Other

The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser

Placebo Low Level Laser therapy

Other

The placebo laser is an identical device to the active laser, made by Irradia Midlaser

Primary outcomes

  1. Function and pain

    Time frame: 26 weeks

    Function and will be assessed using Patient Rating Wrist and Hand Evaluation a (PRWHE), and questions about night pain/pain killers

Secondary outcomes

  1. Pain by pressure

    Time frame: 26 weeks

    Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry

  2. Swelling

    Time frame: 26 weeks

    Swelling will be assessed using measurement tape

  3. Active range of motion

    Time frame: 26 weeks

    Active range of motion will be assessed using goniometer

  4. Grip- and pinch Strength

    Time frame: 26 weeks

    Strength will be assessed using handheld dynamometer

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Norwegian Fund for Postgraduate Training in Physiotherapy

Registry information

Official study title

A Double-blind Placebo-controlled Study of Low-level Laser Therapy in Wrist Fractures

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 25, 2016
Registry last updated
Apr 30, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.