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Low-level Laser Therapy in Wrist Fractures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749929
Enrollment
53
Registered
2016-04-25
Start date
2016-04-30
Completion date
2021-04-27
Last updated
2021-04-30

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

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.

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.

Interventions

OTHERLow level laser therapy

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

The placebo laser is an identical device to the active laser, made by Irradia Midlaser

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Function and pain26 weeksFunction and will be assessed using Patient Rating Wrist and Hand Evaluation a (PRWHE), and questions about night pain/pain killers

Secondary

MeasureTime frameDescription
Pain by pressure26 weeksPain Pressure Threshold over distal radius will be assessed using Pressure Algometry
Swelling26 weeksSwelling will be assessed using measurement tape
Active range of motion26 weeksActive range of motion will be assessed using goniometer
Grip- and pinch Strength26 weeksStrength will be assessed using handheld dynamometer

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026