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Completed

NCT Number: NCT03014024

Low-level Laser Therapy in Distal Radius Fractures

Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks. After removing the cast, it is common to still have pain, swelling and reduced mobility in the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.

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Key information

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

Patient with distal radius fractures are after removal of the cast are recruited form Bergen Emergency Department, where the are randomly divided into two groups with concealed allocation. Patient will be treated 3 times a week, for 3 week. After removal of the cast, the patients pain threshold, swelling, AROM, strength and function is measured. The patients will meet for following-up controls until 26 weeks after injury.

Changes in outcome measures during the study:

Due to covid 19 virus restrictions, we had to abandon the objective physical measurements as planned. Primary outcome measures were retrieved allowing no physical contact with the participants (Ipad, telephone or e-mail).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with distal radius fracture, with or without ulna fracture (Colles' fracture
  • The breach must be closed
  • after reduction: 0 degrees dorsal displacement of radius
  • Under 5 degrees 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 hav a peripheral neve injury
  • If the patient had (previously) operated the 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 removal of the cast

Treatment and study plan

Low-level laser therapy

Other

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

Placebo Low Level Laser therapy

Other

This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.

Primary outcomes

  1. Function and pain

    Time frame: 26 weeks

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

Secondary outcomes

  1. Pain assessed using Pressure Algometer

    Time frame: 26 weeks

    Pressure Algometer

  2. Swelling will be assessed using measurement tape

    Time frame: 26 weeks

    Swelling will be assessed using measurement tape

  3. Active range of motion will be assessed using goniometer

    Time frame: 26 weeks

    Active range of motion will be assessed using goniometer

  4. Strength will be assessed using dynamometer

    Time frame: 26 weeks

    Strength will be assessed using dynamometer

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jan 9, 2017
Registry last updated
May 18, 2022

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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