<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014024</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1633</org_study_id>
    <nct_id>NCT03014024</nct_id>
  </id_info>
  <brief_title>Low-level Laser Therapy in Distal Radius Fractures</brief_title>
  <official_title>A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bergen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks.&#xD;
      After removing the cast, it is common to still have pain, swelling and reduced mobility in&#xD;
      the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient with distal radius fractures are after removal of the cast are recruited form Bergen&#xD;
      Emergency Department, where the are randomly divided into two groups with concealed&#xD;
      allocation. Patient will be treated 3 times a week, for 3 week. After removal of the cast,&#xD;
      the patients pain threshold, swelling, AROM, strength and function is measured. The patients&#xD;
      will meet for following-up controls until 26 weeks after injury.&#xD;
&#xD;
      Changes in outcome measures during the study:&#xD;
&#xD;
      Due to covid 19 virus restrictions, we had to abandon the objective physical measurements as&#xD;
      planned. Primary outcome measures were retrieved allowing no physical contact with the&#xD;
      participants (Ipad, telephone or e-mail).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Function and pain</measure>
    <time_frame>26 weeks</time_frame>
    <description>Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessed using Pressure Algometer</measure>
    <time_frame>26 weeks</time_frame>
    <description>Pressure Algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling will be assessed using measurement tape</measure>
    <time_frame>26 weeks</time_frame>
    <description>Swelling will be assessed using measurement tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Active range of motion will be assessed using goniometer</measure>
    <time_frame>26 weeks</time_frame>
    <description>Active range of motion will be assessed using goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength will be assessed using dynamometer</measure>
    <time_frame>26 weeks</time_frame>
    <description>Strength will be assessed using dynamometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Colles' Fracture</condition>
  <arm_group>
    <arm_group_label>Low-Level Laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Low-Level Laser therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Level Laser Therapy</intervention_name>
    <description>The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser</description>
    <arm_group_label>Low-Level Laser therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Low Level Laser therapy</intervention_name>
    <description>This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.</description>
    <arm_group_label>Placebo Low-Level Laser therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with distal radius fracture, with or without ulna fracture (Colles' fracture&#xD;
&#xD;
          -  The breach must be closed&#xD;
&#xD;
          -  after reduction: 0 degrees dorsal displacement of radius&#xD;
&#xD;
          -  Under 5 degrees shortening of the radius&#xD;
&#xD;
          -  Under 3 mm step in the joint&#xD;
&#xD;
          -  18+ years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who do not speak Norwegian or English&#xD;
&#xD;
          -  If the patient is pregnant&#xD;
&#xD;
          -  Patient with Smith fracture&#xD;
&#xD;
          -  Wounds over fracture area&#xD;
&#xD;
          -  If the patient hav a peripheral neve injury&#xD;
&#xD;
          -  If the patient had (previously) operated the wrist&#xD;
&#xD;
          -  Persons with verified osteoporosis at the time of injury, systemic inflammatory&#xD;
             disease (rheumatism), mental illness, stroke, Parkinson's disease, multiple sclerosis,&#xD;
             cancer or congenital malformations in wrist&#xD;
&#xD;
          -  If the laser treatment can not be started within 3 days after removal of the cast&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Magnus Bjordal, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bergen Accident Emergency Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Humaira Sæbø</investigator_full_name>
    <investigator_title>MS</investigator_title>
  </responsible_party>
  <keyword>Distal Radius Fracture</keyword>
  <keyword>Low Level Laser Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colles' Fracture</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014024
org study id: 2016/1633
nct id: NCT03014024
lead sponsor: 
has dmc: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Function and pain
time frame: 26 weeks
description: Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers
measure: Pain assessed using Pressure Algometer
time frame: 26 weeks
description: Pressure Algometer
measure: Swelling will be assessed using measurement tape
time frame: 26 weeks
description: Swelling will be assessed using measurement tape
measure: Active range of motion will be assessed using goniometer
time frame: 26 weeks
description: Active range of motion will be assessed using goniometer
measure: Strength will be assessed using dynamometer
time frame: 26 weeks
description: Strength will be assessed using dynamometer
arm group label: Low-Level Laser therapy
arm group type: Experimental
description: 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.
arm group label: Placebo Low-Level Laser therapy
arm group type: Placebo Comparator
description: 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.
intervention type: Other
intervention name: Low-Level Laser Therapy
description: The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
arm group label: Low-Level Laser therapy
intervention type: Other
intervention name: Placebo Low Level Laser therapy
description: This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.
arm group label: Placebo Low-Level Laser therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Magnus Bjordal, Professor
role: Study Director
affiliation: University of Bergen
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Humaira Sæbø
investigator title: MS
mesh term: Colles' Fracture
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
sharing ipd: No