Clinical trial NCT03750279: Inflammatory Targeted Laser Treatment of Knee Osteoarthritis
Official title: Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Inflammation
Photobiomodulation
Low-level laser therapy
Double-blind
Randomized clinical trial
RCT
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Pain on movement
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Pain at night
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Pain at rest
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Pain in general
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
Secondary outcomes:
measure: Physical function in daily living
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Physical function in sports and recreational activities
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Quality of life
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Global health status assessment
timeFrame: 8 weeks after randomization
measure: Real time ultrasonography assessment of effusion
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Real time ultrasonography assessment of neovascularization
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Real time ultrasonography assessment of femur cartilage thickness
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: 30 seconds chair stand
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Knee extension active range of motion
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Knee flexion active range of motion
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Maximum pain free isometric quadriceps strength
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Joint line pain pressure threshold
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Tibia bone pain pressure threshold
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
measure: Analgesic drug consumption due to knee pain
timeFrame: 0, 3, 8, 26 and 52 weeks after randomization
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
References: