An interventional study of Exercise therapy and LLLT in Knee Osteoarthritis, sponsored by University of Bergen. Completed at 1 site in Norway. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by University of Bergen · Not applicable, Interventional, and Treatment
This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct to exercise therapy in knee osteoarthritis (KOA).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Bergen is the lead sponsor of 141 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
* 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.
Other: Exercise therapy · Other: 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.
Other: Exercise therapy · Other: Sham LLLT
* 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.
- 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.
- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Pain on movement
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.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Pain at night
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.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Pain at rest
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.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Pain in general
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).
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Physical function in daily living
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).
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Physical function in sports and recreational activities
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).
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Quality of life
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).
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Global health status assessment
The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).
Time frame: 8 weeks after randomization
Real time ultrasonography assessment of effusion
Maximum height will be measured.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Real time ultrasonography assessment of neovascularization
Doppler area will be measured.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Real time ultrasonography assessment of femur cartilage thickness
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
30 seconds chair stand
Last attempt counts if the participant is more than half way up.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Knee extension active range of motion
A 30 cm goniometer is used.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Knee flexion active range of motion
A 30 cm goniometer is used.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Maximum pain free isometric quadriceps strength
A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Joint line pain pressure threshold
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.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Tibia bone pain pressure threshold
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.
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Analgesic drug consumption due to knee pain
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
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University of Bergen