Low-level Laser Therapy in Distal Radius Fractures

NCT ID: NCT03014024

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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).

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, 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.

Group Type: EXPERIMENTAL

Low-Level Laser Therapy

Intervention Type: OTHER

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

Placebo Low-Level Laser therapy

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.

Group Type: PLACEBO_COMPARATOR

Placebo Low Level Laser therapy

Intervention Type: OTHER

This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.

Interventions

Low-Level Laser Therapy

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

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

References

Saebo H, Naterstad IF, Joensen J, Stausholm MB, Bjordal JM. Pain and Disability of Conservatively Treated Distal Radius Fracture: A Triple-Blinded Randomized Placebo-Controlled Trial of Photobiomodulation Therapy. Photobiomodul Photomed Laser Surg. 2022 Jan;40(1):33-41. doi: 10.1089/photob.2021.0125.

Reference Type: DERIVED

PMID: 35030040 (View on PubMed)

Other Identifiers

2016/1633

Identifier Type: -

Identifier Source: org_study_id