Low-level Laser Therapy in Wrist Fractures

NCT ID: NCT02749929

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-04-27

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.

Conditions

Colles' Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low level laser therapy

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Low Level Laser Therapy

Intervention Type: OTHER

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

Interventions

Low level laser therapy

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

Intervention Type: OTHER

Placebo Low Level Laser Therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Humaira Sæbø

MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Magnus Bjordal, Professor

Role: STUDY_DIRECTOR

University of Bergen

Locations

Bergen Accident Emergency Hospital

Bergen, , Norway

Countries

Norway

Other Identifiers

569093

Identifier Type: -

Identifier Source: org_study_id