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

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.

Study Overview

• Status: Completed
• Conditions: Colles' Fracture
• Intervention / Treatment: Other: Low-Level Laser Therapy; Other: Placebo Low Level Laser therapy

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Bergen Accident Emergency Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Level Laser therapy; 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; The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
Placebo Comparator: Placebo Low-Level Laser therapy; 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; This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bergen
• Investigators: Study Director: Jan Magnus Bjordal, Professor, University of Bergen

Publications and helpful links

General Publications

• Saebo H, Naterstad IF, Joensen J, Stausholm MB, Bjordal JM. Pain and Disability of Conservatively Treated Distal Radius Fracture: A Triple-Blinded Randomized Placebo-Controlled Trial of Photobiomodulation Therapy. Photobiomodul Photomed Laser Surg. 2022 Jan;40(1):33-41. doi: 10.1089/photob.2021.0125.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Distal Radius Fracture; Low Level Laser Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Arm Injuries; Forearm Injuries; Fracture Dislocation; Fractures, Bone; Radius Fractures; Colles' Fracture
• Other Study ID Numbers: 2016/1633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No