<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/NCT03750279</url>
  </required_header>
  <id_info>
    <org_study_id>Bergen KOA laser RCT</org_study_id>
    <nct_id>NCT03750279</nct_id>
  </id_info>
  <brief_title>Inflammatory Targeted Laser Treatment of Knee Osteoarthritis</brief_title>
  <official_title>Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an&#xD;
      adjunct to exercise therapy in knee osteoarthritis (KOA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2018</start_date>
  <completion_date type="Actual">August 24, 2021</completion_date>
  <primary_completion_date type="Actual">August 24, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Two laser devices of the same appearance are used, i.e. one with 3x60 mW output power and one with 0 mW output power (sham). Participants in one group is treated with the sham laser device and the other group is treated with laser. The laser beam is invisible for the eye (wavelength 904 nm) and of such low power that heat is not detected. Thus, the participants, therapists and assessors are unaware of which laser device is active/inactive. The laser devices were randomly coded by a secretary who is not otherwise involved in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain on movement</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>The participants are asked to rate their pain experienced on movement using an unidimensional visual analogue scale (VAS). &quot;No pain&quot; (0) is written in one end and &quot;worst imaginable pain&quot; (100) is written in the other end of the VAS tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain at night</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>The participants are asked to rate their pain experienced in bed at night using an unidimensional visual analogue scale (VAS). &quot;No pain&quot; (0) is written in one end and &quot;worst imaginable pain&quot; (100) is written in the other end of the VAS tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain at rest</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>The participants are asked to rate their pain experienced at rest in sitting position using an unidimensional visual analogue scale (VAS). &quot;No pain&quot; (0) is written in one end and &quot;worst imaginable pain&quot; (100) is written in the other end of the VAS tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain in general</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Pain in general is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire pain subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical function in daily living</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Physical function in daily living is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire physical function in daily living subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function in sports and recreational activities</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Physical function in sports and recreational activities is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire physical function in sports and recreational activities subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Quality of life is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire quality of life subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global health status assessment</measure>
    <time_frame>8 weeks after randomization</time_frame>
    <description>The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real time ultrasonography assessment of effusion</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Maximum height will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real time ultrasonography assessment of neovascularization</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Doppler area will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Real time ultrasonography assessment of femur cartilage thickness</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 seconds chair stand</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>Last attempt counts if the participant is more than half way up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee extension active range of motion</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>A 30 cm goniometer is used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee flexion active range of motion</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>A 30 cm goniometer is used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum pain free isometric quadriceps strength</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint line pain pressure threshold</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>The most tender spot in the medial knee joint line is identified with palpation. Subsequently, a pain pressure threshold algometer is used at this spot. The display of the algometer is not visible during the procedure in order to blind the assessor for the level of pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tibia bone pain pressure threshold</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
    <description>The most tender spot in the medial knee joint line is identified with palpation. Subsequently, a pain pressure threshold algometer is used 1.5 cm distally from this spot. The display of the algometer is not visible during the procedure in order to blind the assessor for the level of pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic drug consumption due to knee pain</measure>
    <time_frame>0, 3, 8, 26 and 52 weeks after randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Exercise therapy + LLLT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise therapy 3 times per week for 8 weeks from baseline.&#xD;
LLLT applied to the knee 3 times per week for 3 weeks from baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise therapy + sham LLLT</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Exercise therapy 3 times per week for 8 weeks from baseline.&#xD;
Sham LLLT applied to the knee 3 times per week for 3 weeks from baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise therapy</intervention_name>
    <description>5 min. warm up with light exercises for the lower limb prior to strength/endurance exercise therapy.&#xD;
Strength/endurance exercise therapy including level 1 or 2 per session:&#xD;
Level 1: Pelvic lifts (2x15 rep.), one-legged knee bends (2x10 rep. per leg), hip abductions (2x10 rep. per leg). The participants may progress from level 1 to level 2.&#xD;
Level 2: Pelvic lifts (3x15 rep.), one-legged knee bends (3x10 rep. per leg), hip abductions (2x10 rep. per leg), sideways slide (2x10 rep. per leg), and backwards slide (2x10 rep. per leg). The participants may regress from level 2 to level 1.</description>
    <arm_group_label>Exercise therapy + LLLT</arm_group_label>
    <arm_group_label>Exercise therapy + sham LLLT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LLLT</intervention_name>
    <description>- LLLT (60 mW mean output per probe, 904 nm wavelength) applied to the knee in adherence with the recommendations by World Association for Laser Therapy, in terms of dosage per treatment spot.</description>
    <arm_group_label>Exercise therapy + LLLT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham LLLT</intervention_name>
    <description>- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).</description>
    <arm_group_label>Exercise therapy + sham LLLT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Any gender&#xD;
&#xD;
          -  Age ≥ 50 years&#xD;
&#xD;
          -  Pain on movement ≥ 40 mm Visual Analog Scale&#xD;
&#xD;
          -  Knee pain for the last ≥ 3 months&#xD;
&#xD;
          -  KOA verified with the American College of Rheumatology criteria using a history and&#xD;
             physical examination, i.e. knee pain and at least three of the following: ≥ 50 years&#xD;
             old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony&#xD;
             tenderness, bony enlargement, and no palpable warmth of synovia&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Knee alloplastic&#xD;
&#xD;
          -  Total meniscectomy&#xD;
&#xD;
          -  Intra-articular steroid injection and/or oral steroid treatment within the last six&#xD;
             months&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Severe cognitive deficit&#xD;
&#xD;
          -  Neurological deficits affecting the knee&#xD;
&#xD;
          -  Inability to speak and understand English/Norwegian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Bergen</name>
      <address>
        <city>Bergen</city>
        <zip>5018</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee osteoarthritis</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Photobiomodulation</keyword>
  <keyword>Low-level laser therapy</keyword>
  <keyword>Double-blind</keyword>
  <keyword>Randomized clinical trial</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03750279
org study id: Bergen KOA laser RCT
nct id: NCT03750279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an
      adjunct to exercise therapy in knee osteoarthritis (KOA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Two laser devices of the same appearance are used, i.e. one with 3x60 mW output power and one with 0 mW output power (sham). Participants in one group is treated with the sham laser device and the other group is treated with laser. The laser beam is invisible for the eye (wavelength 904 nm) and of such low power that heat is not detected. Thus, the participants, therapists and assessors are unaware of which laser device is active/inactive. The laser devices were randomly coded by a secretary who is not otherwise involved in the study.
measure: Pain on movement
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: The participants are asked to rate their pain experienced on movement using an unidimensional visual analogue scale (VAS). "No pain" (0) is written in one end and "worst imaginable pain" (100) is written in the other end of the VAS tool.
measure: Pain at night
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: The participants are asked to rate their pain experienced in bed at night using an unidimensional visual analogue scale (VAS). "No pain" (0) is written in one end and "worst imaginable pain" (100) is written in the other end of the VAS tool.
measure: Pain at rest
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: The participants are asked to rate their pain experienced at rest in sitting position using an unidimensional visual analogue scale (VAS). "No pain" (0) is written in one end and "worst imaginable pain" (100) is written in the other end of the VAS tool.
measure: Pain in general
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Pain in general is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire pain subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).
measure: Physical function in daily living
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Physical function in daily living is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire physical function in daily living subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).
measure: Physical function in sports and recreational activities
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Physical function in sports and recreational activities is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire physical function in sports and recreational activities subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).
measure: Quality of life
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Quality of life is reported with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire quality of life subscale. The subscale is based on Likert scales, each with five severity categories. The raw KOOS score is transformed to a 0-100 percentage score (higher is better).
measure: Global health status assessment
time frame: 8 weeks after randomization
description: The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).
measure: Real time ultrasonography assessment of effusion
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Maximum height will be measured.
measure: Real time ultrasonography assessment of neovascularization
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Doppler area will be measured.
measure: Real time ultrasonography assessment of femur cartilage thickness
time frame: 0, 3, 8, 26 and 52 weeks after randomization
measure: 30 seconds chair stand
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: Last attempt counts if the participant is more than half way up.
measure: Knee extension active range of motion
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: A 30 cm goniometer is used.
measure: Knee flexion active range of motion
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: A 30 cm goniometer is used.
measure: Maximum pain free isometric quadriceps strength
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.
measure: Joint line pain pressure threshold
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: The most tender spot in the medial knee joint line is identified with palpation. Subsequently, a pain pressure threshold algometer is used at this spot. The display of the algometer is not visible during the procedure in order to blind the assessor for the level of pressure.
measure: Tibia bone pain pressure threshold
time frame: 0, 3, 8, 26 and 52 weeks after randomization
description: The most tender spot in the medial knee joint line is identified with palpation. Subsequently, a pain pressure threshold algometer is used 1.5 cm distally from this spot. The display of the algometer is not visible during the procedure in order to blind the assessor for the level of pressure.
measure: Analgesic drug consumption due to knee pain
time frame: 0, 3, 8, 26 and 52 weeks after randomization
arm group label: Exercise therapy + LLLT
arm group type: Active Comparator
description: Exercise therapy 3 times per week for 8 weeks from baseline.
LLLT applied to the knee 3 times per week for 3 weeks from baseline.
arm group label: Exercise therapy + sham LLLT
arm group type: Placebo Comparator
description: Exercise therapy 3 times per week for 8 weeks from baseline.
Sham LLLT applied to the knee 3 times per week for 3 weeks from baseline.
intervention type: Other
intervention name: Exercise therapy
description: 5 min. warm up with light exercises for the lower limb prior to strength/endurance exercise therapy.
Strength/endurance exercise therapy including level 1 or 2 per session:
Level 1: Pelvic lifts (2x15 rep.), one-legged knee bends (2x10 rep. per leg), hip abductions (2x10 rep. per leg). The participants may progress from level 1 to level 2.
Level 2: Pelvic lifts (3x15 rep.), one-legged knee bends (3x10 rep. per leg), hip abductions (2x10 rep. per leg), sideways slide (2x10 rep. per leg), and backwards slide (2x10 rep. per leg). The participants may regress from level 2 to level 1.
arm group label: Exercise therapy + LLLT
arm group label: Exercise therapy + sham LLLT
intervention type: Other
intervention name: LLLT
description: - LLLT (60 mW mean output per probe, 904 nm wavelength) applied to the knee in adherence with the recommendations by World Association for Laser Therapy, in terms of dosage per treatment spot.
arm group label: Exercise therapy + LLLT
intervention type: Other
intervention name: Sham LLLT
description: - Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
arm group label: Exercise therapy + sham LLLT
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No