Low-level Laser Therapy in Distal Radius Fractures

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2020

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.

Interventions

  • Other: Low-Level Laser Therapy
    • The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Function and pain
    • Time Frame: 26 weeks
    • Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers

Secondary Measures

  • Pain assessed using Pressure Algometer
    • Time Frame: 26 weeks
    • Pressure Algometer
  • Swelling will be assessed using measurement tape
    • Time Frame: 26 weeks
    • Swelling will be assessed using measurement tape
  • Active range of motion will be assessed using goniometer
    • Time Frame: 26 weeks
    • Active range of motion will be assessed using goniometer
  • Strength will be assessed using dynamometer
    • Time Frame: 26 weeks
    • Strength will be assessed using dynamometer

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Bergen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Humaira Sæbø, MS – University of Bergen
  • Overall Official(s)
    • Jan Magnus Bjordal, Professor, Study Director, University of Bergen
  • Overall Contact(s)
    • Humaira Sæbø, M.Sc, 98856847, Humaira.Sebo@uib.no

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