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Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03750279
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Bergen

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 22, 2018
Last Update Posted Date November 29, 2018
Actual Study Start Date  ICMJE April 19, 2018
Estimated Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
  • Pain on movement [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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.
  • Pain at night [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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.
  • Pain at rest [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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.
  • Pain in general [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Visual analogue scale (VAS) pain [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
  • Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Questionnaire.
Change History Complete list of historical versions of study NCT03750279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
  • Physical function in daily living [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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).
  • Physical function in sports and recreational activities [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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).
  • Quality of life [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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).
  • Global health status assessment [ Time Frame: Week 8 ]
    The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).
  • Real time ultrasonography assessment of effusion [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
  • Real time ultrasonography assessment of neovascularization [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Doppler activity.
  • Real time ultrasonography assessment of femur cartilage thickness [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
  • 30 seconds chair stand [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Last attempt counts if the participant is more than half way up.
  • Knee extension active range of motion [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    A 30 cm goniometer is used.
  • Knee flexion active range of motion [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    A 30 cm goniometer is used.
  • Maximum pain free isometric quadriceps strength [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.
  • Joint line pain pressure threshold [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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.
  • Tibia bone pain pressure threshold [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    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.
  • Analgesic drug consumption due to knee pain [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Knee injury and Osteoarthritis Outcome Score (KOOS) disability subscale [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Questionarie.
  • Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Questionnaire.
  • Global health status assessment [ Time Frame: Week 8 ]
    The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).
  • Real time ultrasonography assessment of effusion [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
  • Real time ultrasonography assessment of neovascularization [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Doppler activity.
  • Real time ultrasonography assessment of femur cartilage thickness [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
  • 30 seconds chair stand [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    Last attempt counts if the participant is more than half way up.
  • Knee active range of motion (extension and flexion) [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    A 30 cm goniometer is used. The assessment is done with the participant is lying on the back.
  • Maximum pain free isometric quadriceps strength [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    A dynanometer is used. The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.
  • Joint line pain pressure threshold [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    The most tender spot on 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.
  • Tibia bone pain pressure threshold [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
    The most tender spot on 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.
  • Analgesic drug consumption due to knee pain [ Time Frame: Change from baseline to week 3 and 8 and month 6 and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inflammatory Targeted Laser Treatment of Knee Osteoarthritis
Official Title  ICMJE Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial
Brief Summary This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct to exercise therapy in knee osteoarthritis (KOA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Other: Exercise therapy
    • 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.

  • Other: LLLT
    - 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.
  • Other: Sham LLLT
    - Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Study Arms  ICMJE
  • Active Comparator: Exercise therapy + LLLT
    • 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.
    Interventions:
    • Other: Exercise therapy
    • Other: LLLT
  • Placebo Comparator: Exercise therapy + sham LLLT
    • 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.
    Interventions:
    • Other: Exercise therapy
    • Other: Sham LLLT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 19, 2021
Estimated Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Any gender
  • Age ≥ 50 years
  • Pain on movement ≥ 40 mm Visual Analog Scale
  • Knee pain for the last ≥ 3 months
  • KOA verified with the American College of Rheumatology criteria using a history and physical examination, i.e. knee pain and at least three of the following: ≥ 50 years old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and no palpable warmth of synovia

Exclusion criteria:

  • Knee alloplastic
  • Total meniscectomy
  • Intra-articular steroid injection and/or oral steroid treatment within the last six months
  • Cancer
  • Rheumatoid arthritis
  • Severe cognitive deficit
  • Neurological deficits affecting the knee
  • Inability to speak and understand English/Norwegian
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan M Bjordal, PT, professor 004755586073 jan.bjordal@uib.no
Contact: Martin B Stausholm, PT, MSc 004745371771 martin.stausholm@uib.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03750279
Other Study ID Numbers  ICMJE Bergen KOA laser RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Bergen
Study Sponsor  ICMJE University of Bergen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Bergen
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP