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Low-level Laser Therapy on Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT03014024
Recruitment Status : Unknown
Verified January 2017 by Humaira Sæbø, University of Bergen.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Humaira Sæbø, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Colles' Fracture Other: Low-Level Laser Therapy Other: Placebo Low Level Laser therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast on Distal Radius Fractures
Study Start Date : December 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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

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.
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.




Primary Outcome Measures :
  1. Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE) [ Time Frame: 26 weeks ]
    Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE)


Secondary Outcome Measures :
  1. Pain assessed using Pressure Algometer [ Time Frame: 26 weeks ]
    Pressure Algometer

  2. Swelling will be assessed using measurement tape [ Time Frame: 26 weeks ]
    Swelling will be assessed using measurement tape

  3. Active range of motion will be assessed using goniometer [ Time Frame: 26 weeks ]
    Active range of motion will be assessed using goniometer

  4. Strength will be assessed using dynamometer [ Time Frame: 26 weeks ]
    Strength will be assessed using dynamometer



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014024


Contacts
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Contact: Humaira Sæbø, M.Sc 98856847 ext 47 Humaira.Sebo@uib.no
Contact: Jon Joensen, PhD 45048157 ext 47 Jon.Joensen@uib.no

Locations
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Norway
Bergen Accident Emergency Hospital Recruiting
Bergen, Norway
Contact: Humaira Sæbø, M.Sc    98856847 ext 47    Humaira.Sebo@uib.no   
Sponsors and Collaborators
University of Bergen
Investigators
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Study Director: Jan Magnus Bjordal, Professor University of Bergen

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Responsible Party: Humaira Sæbø, MS, University of Bergen
ClinicalTrials.gov Identifier: NCT03014024     History of Changes
Other Study ID Numbers: 2016/1633
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Humaira Sæbø, University of Bergen:
Distal Radius Fracture
Low Level Laser Therapy

Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Colles' Fracture
Wounds and Injuries
Forearm Injuries
Arm Injuries
Fracture Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases