Low-level Laser Therapy in Distal Radius Fractures

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03014024

Enrollment

Registered

2017-01-09

Start date

2016-12-31

Completion date

2021-12-31

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colles' Fracture

Keywords

Distal Radius Fracture, Low Level Laser Therapy

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).

Interventions

OTHERLow-Level Laser Therapy

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

OTHERPlacebo Low Level Laser therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026