Overview

This trial is active, not recruiting.

Condition colles' fracture
Treatments low level laser therapy, placebo low level laser therapy
Sponsor University of Bergen
Collaborator Norwegian Fund for Postgraduate Training in Physiotherapy
Start date April 2016
End date April 2017
Trial size 40 participants
Trial identifier NCT02749929, 569093

Summary

Approximately 15,000 persons in Norway suffer from a wristfracture 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, physical therapy 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. There are no studies assessing the effect of LLLT for distal radius fractures beyond two weeks. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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 participants eyes will be protected with dark glasses before the treatment is started. The laser is a superpulsed infrared laser with a wavelength of 904 nm, belonging to laserclass 3B. The light from the laser is not visible to the eye, and will not give any perceptible stimulus. 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.
low level laser therapy
The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser
(Placebo Comparator)
After inclusion in the study, a small window of approximately 1 cm2 opening will be made in the cast in order for the placebolaser to make skin contact. The patients eyes will be protected with dark glasses before the treatment is started. The placebolaser is identical in apperance to a superpulsed infrared laser with a wavelength of 904 nm, belonging to laserclass 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.
placebo low level laser therapy
The placebo laser is an identical device to the active laser, made by Irradia Midlaser

Primary Outcomes

Measure
Active range of motion
time frame: 26 weeks
Pain
time frame: 26 weeks
Swelling
time frame: 26 weeks
Strength
time frame: 26 weeks

Secondary Outcomes

Measure
Function
time frame: 26 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Doubleblind Placebo-controlled Study of Low Level Laser Therapy in Wrist Fractures
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 of paris, with a small opening where Low Level Laser therapy can be administered in skin contact. The patients will receive daily treatment for two 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Bergen.