Low-level Laser Therapy in Distal Radius Fractures

Not Applicable

Completed

• Conditions: Colles' Fracture

• Registration Number: NCT03014024
• Lead Sponsor: University of Bergen

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Primary Completion: 2020-06
• Study Completion: 2021-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Function and pain	26 weeks	Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers

Secondary Outcome Measures

Name	Time	Method
Swelling will be assessed using measurement tape	26 weeks	Swelling will be assessed using measurement tape
Pain assessed using Pressure Algometer	26 weeks	Pressure Algometer
Strength will be assessed using dynamometer	26 weeks	Strength will be assessed using dynamometer
Active range of motion will be assessed using goniometer	26 weeks	Active range of motion will be assessed using goniometer

Trial Locations

Locations (1)

Bergen Accident Emergency Hospital; 🇳🇴 Bergen, Norway