Low-level Laser Therapy in Wrist Fractures

A Double-blind Placebo-controlled Study of Low-level Laser Therapy in Wrist Fractures

Approximately 15,000 persons in Norway suffer from wrist fractures during a year, making it the most prevalent fracture in this country. Treated conservatively, a cast is used for 4-6 weeks before removal. After discontinuation of the cast, physiotherapy is implemented to aid in improving range of motion and regaining function of the injured wrist. The pain after injury can affect the patient to a greater or lesser extent, and it is common to prescribe sick leave for shorter amounts of time after the injury.

Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may reduce pain and swelling after acute trauma, and potentially promote healing. The aim of this study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks after injury.

Study Overview

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

Detailed Description

Patients with wrist fractures are recruited from Bergen Municipal Emergency Ward, where they are randomly divided into two groups with concealed allocation. The fracture is immobilized with a cast, with a small opening where Low Level Laser therapy can be administered in skin contact. The patients will receive treatment 3 times a week, for 3 weeks. After discontinuation of the cast, the patients swelling, pain, grip strength and function of the wrist is measured. The patients will meet for follow-up controls until 26 weeks after injury.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Bergen Accident Emergency Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with distal radiusfraktur, with or without ulna fracture Colles' fracture
• The breach must be closed
• Under 10 degrees dorsal displacement of radius
• Under 5mm 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 have a peripheral nerve injury
• If the patient had (previously) operated 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 fracture

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, a small window of approximately 1 cm2 opening will be made in the cast in order for the laser to make skin contact. The laser is a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. The light from the laser is not visible to the eye, and will not give any perceptible stimulus. Low-Level Laser therapy (LLLT) will be given according to the recommended dosage from World Association of Laser Therapy (WALT). A LLLT dose of 3.6 Joules will be administered at two points over the fracture site.	Other: Low level laser therapy; The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser
Placebo Comparator: Placebo Low-Level Laser therapy; After inclusion in the study, a small window of approximately 1 cm2 opening will be made in the cast in order for the placebo laser to make skin contact. The placebo laser is identical in apperance to a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Since the light from the laser is invisible, neither the participant nor the therapist will know whether the laser is a placebo. The treatment time and number of treated points will be identical to group 1.	Other: Placebo Low Level Laser Therapy; The placebo laser is an identical device to the active laser, made by Irradia Midlaser

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain by pressure	Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry	26 weeks
Swelling	Swelling will be assessed using measurement tape	26 weeks
Active range of motion	Active range of motion will be assessed using goniometer	26 weeks
Grip- and pinch Strength	Strength will be assessed using handheld dynamometer	26 weeks

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Study Director: Jan Magnus Bjordal, Professor, University of Bergen

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

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; Fracture Dislocation; Radius Fractures; Fractures, Bone; Colles' Fracture
• Other Study ID Numbers: 569093

Plan for Individual participant data (IPD)

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