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Clinical Trials/NCT03750279
NCT03750279
Completed
Not Applicable

Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial

University of Bergen1 site in 1 country50 target enrollmentApril 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of Bergen
Enrollment
50
Locations
1
Primary Endpoint
Pain in general
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 19, 2018
End Date
August 24, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain in general

Time Frame: 0, 3, 8, 26 and 52 weeks after randomization

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).

Pain on movement

Time Frame: 0, 3, 8, 26 and 52 weeks after randomization

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: 0, 3, 8, 26 and 52 weeks after randomization

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: 0, 3, 8, 26 and 52 weeks after randomization

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.

Secondary Outcomes

  • Physical function in sports and recreational activities(0, 3, 8, 26 and 52 weeks after randomization)
  • Real time ultrasonography assessment of neovascularization(0, 3, 8, 26 and 52 weeks after randomization)
  • 30 seconds chair stand(0, 3, 8, 26 and 52 weeks after randomization)
  • Tibia bone pain pressure threshold(0, 3, 8, 26 and 52 weeks after randomization)
  • Real time ultrasonography assessment of femur cartilage thickness(0, 3, 8, 26 and 52 weeks after randomization)
  • Knee extension active range of motion(0, 3, 8, 26 and 52 weeks after randomization)
  • Maximum pain free isometric quadriceps strength(0, 3, 8, 26 and 52 weeks after randomization)
  • Joint line pain pressure threshold(0, 3, 8, 26 and 52 weeks after randomization)
  • Physical function in daily living(0, 3, 8, 26 and 52 weeks after randomization)
  • Quality of life(0, 3, 8, 26 and 52 weeks after randomization)
  • Global health status assessment(8 weeks after randomization)
  • Real time ultrasonography assessment of effusion(0, 3, 8, 26 and 52 weeks after randomization)
  • Knee flexion active range of motion(0, 3, 8, 26 and 52 weeks after randomization)
  • Analgesic drug consumption due to knee pain(0, 3, 8, 26 and 52 weeks after randomization)

Study Sites (1)

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