Inflammatory Targeted Laser Treatment of Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Other: Exercise therapyOther: Sham LLLTOther: LLLT
- Registration Number
- NCT03750279
- Lead Sponsor
- University of Bergen
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise therapy + sham LLLT Exercise therapy * 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. Exercise therapy + sham LLLT 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. Exercise therapy + LLLT Exercise therapy * 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. Exercise therapy + LLLT 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.
- Primary Outcome Measures
Name Time Method Pain in general 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 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 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 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 Outcome Measures
Name Time Method Physical function in sports and recreational activities 0, 3, 8, 26 and 52 weeks after randomization 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).
Real time ultrasonography assessment of neovascularization 0, 3, 8, 26 and 52 weeks after randomization Doppler area will be measured.
30 seconds chair stand 0, 3, 8, 26 and 52 weeks after randomization Last attempt counts if the participant is more than half way up.
Tibia bone pain pressure threshold 0, 3, 8, 26 and 52 weeks after randomization 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.
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 A 30 cm goniometer is used.
Maximum pain free isometric quadriceps strength 0, 3, 8, 26 and 52 weeks after randomization 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 0, 3, 8, 26 and 52 weeks after randomization 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.
Physical function in daily living 0, 3, 8, 26 and 52 weeks after randomization 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).
Quality of life 0, 3, 8, 26 and 52 weeks after randomization 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 8 weeks after randomization 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 0, 3, 8, 26 and 52 weeks after randomization Maximum height will be measured.
Knee flexion active range of motion 0, 3, 8, 26 and 52 weeks after randomization A 30 cm goniometer is used.
Analgesic drug consumption due to knee pain 0, 3, 8, 26 and 52 weeks after randomization
Trial Locations
- Locations (1)
University of Bergen
🇳🇴Bergen, Norway