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Clinical Trials/NCT03014024
NCT03014024
Completed
Not Applicable

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

University of Bergen1 site in 1 country50 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colles' Fracture
Sponsor
University of Bergen
Enrollment
50
Locations
1
Primary Endpoint
Function and pain
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Humaira Sæbø

MS

University of Bergen

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

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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