Low-level Laser Therapy in Distal Radius Fractures

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Colles' Fracture

Intervention / Treatment
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* Other: Low-Level Laser Therapy
* Other: Placebo Low Level Laser therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Level Laser therapy<br>After inclusion in the study, patients will be treated with LLLT. The laser is a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Patient will be treated from dorsal side of the wrist on the fracture area, and distal ulna area from the palmar side. Total 20 second on each side (3 points), with 3,6 J/cm2. the light from the laser is not visible to the eye, and will not give any perceptible stimulus. The x-ray will be used to find the fracture line. | Other: Low-Level Laser Therapy<br>* The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser<br>|
| Placebo Comparator: Placebo Low-Level Laser therapy<br>After inclusion in the study, patients will be treated with placebo LLLT. This placebo laser is identical in appearance to the other super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Patient will be treated on the same areas, and have the same procedure and time. Since the light from the laser is invisible neither the participant nor the therapist will know whether the laser is a placebo. | Other: Placebo Low Level Laser therapy<br>* This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function and pain | Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers | 26 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Radius Fracture, Low Level Laser Therapy