Low-level Laser Therapy in Wrist Fractures

Colles' Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749929
• Other study ID #: 569093
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 27, 2021

Study information

• Verified date: April 2021
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 27, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone

Intervention

Other:
• Low level laser therapy
The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser
• Placebo Low Level Laser Therapy
The placebo laser is an identical device to the active laser, made by Irradia Midlaser

Locations

Country	Name	City	State
Norway	Bergen Accident Emergency Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

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