Low-level Laser Therapy in Distal Radius Fractures

Colles' Fracture Clinical Trial

Official title:

A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014024
• Other study ID #: 2016/1633
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: May 2022
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Low-Level Laser Therapy
The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
• Placebo Low Level Laser therapy
This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.

Locations

Country	Name	City	State
Norway	Bergen Accident Emergency Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function and pain	Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers	26 weeks
Secondary	Pain assessed using Pressure Algometer	Pressure Algometer	26 weeks
Secondary	Swelling will be assessed using measurement tape	Swelling will be assessed using measurement tape	26 weeks
Secondary	Active range of motion will be assessed using goniometer	Active range of motion will be assessed using goniometer	26 weeks
Secondary	Strength will be assessed using dynamometer	Strength will be assessed using dynamometer	26 weeks