Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, Inflammation, Photobiomodulation, Low-level laser therapy, Double-blind, Randomized clinical trial, RCT
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).
Interventions
OTHERExercise 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.
OTHERLLLT
\- 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.
OTHERSham LLLT
\- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Sponsors
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real time ultrasonography assessment of effusion | 0, 3, 8, 26 and 52 weeks after randomization | Maximum height will be measured. |
| Real time ultrasonography assessment of neovascularization | 0, 3, 8, 26 and 52 weeks after randomization | Doppler area will be measured. |
| Real time ultrasonography assessment of femur cartilage thickness | 0, 3, 8, 26 and 52 weeks after randomization | — |
| 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. |
| Knee extension active range of motion | 0, 3, 8, 26 and 52 weeks after randomization | A 30 cm goniometer is used. |
| 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). |
| 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. |
| 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. |
| Analgesic drug consumption due to knee pain | 0, 3, 8, 26 and 52 weeks after randomization | — |
| Knee flexion active range of motion | 0, 3, 8, 26 and 52 weeks after randomization | A 30 cm goniometer is used. |
| 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). |
| 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). |
Countries
Norway
Outcome results
None listed