Low-level Laser Therapy in Distal Radius Fractures

University of Bergen

Status: Completed

Conditions: Colles' Fracture

Treatments: Other: Low-Level Laser Therapy; Other: Placebo Low Level Laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03014024

2016/1633

Details and patient eligibility

About

Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks. After removing the cast, it is common to still have pain, swelling and reduced mobility in the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.

Full description

Patient with distal radius fractures are after removal of the cast are recruited form Bergen Emergency Department, where the are randomly divided into two groups with concealed allocation. Patient will be treated 3 times a week, for 3 week. After removal of the cast, the patients pain threshold, swelling, AROM, strength and function is measured. The patients will meet for following-up controls until 26 weeks after injury.

Changes in outcome measures during the study:

Due to covid 19 virus restrictions, we had to abandon the objective physical measurements as planned. Primary outcome measures were retrieved allowing no physical contact with the participants (Ipad, telephone or e-mail).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with distal radius fracture, with or without ulna fracture (Colles' fracture
• The breach must be closed
• after reduction: 0 degrees dorsal displacement of radius
• Under 5 degrees 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 hav a peripheral neve injury
• If the patient had (previously) operated the 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 removal of the cast

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Low-Level Laser therapy

Experimental group

Description:

After inclusion in the study, patients will be treated with LLLT. The laser is a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Patient will be treated from dorsal side of the wrist on the fracture area, and distal ulna area from the palmar side. Total 20 second on each side (3 points), with 3,6 J/cm2. the light from the laser is not visible to the eye, and will not give any perceptible stimulus. The x-ray will be used to find the fracture line.

Treatment:

Other: Low-Level Laser Therapy

Placebo Low-Level Laser therapy

Placebo Comparator group

Description:

After inclusion in the study, patients will be treated with placebo LLLT. This placebo laser is identical in appearance to the other super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Patient will be treated on the same areas, and have the same procedure and time. Since the light from the laser is invisible neither the participant nor the therapist will know whether the laser is a placebo.

Treatment:

Other: Placebo Low Level Laser therapy