Clinical trial NCT02749929: Low-level Laser Therapy in Wrist Fractures
Official title: A Double-blind Placebo-controlled Study of Low-level Laser Therapy in Wrist Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles' Fracture
Keywords: Distal radius fracture, Low Level Laser Therapy
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2016-04-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Function and pain
timeFrame: 26 weeks
Secondary outcomes:
measure: Pain by pressure
timeFrame: 26 weeks
measure: Swelling
timeFrame: 26 weeks
measure: Active range of motion
timeFrame: 26 weeks
measure: Grip- and pinch Strength
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Accident Emergency Hospital
Study officials:
affiliation: University of Bergen
name: Jan Magnus Bjordal, Professor
role: STUDY_DIRECTOR
References: