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This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct to exercise therapy in knee osteoarthritis (KOA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise therapy + LLLT | Active Comparator |
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| Exercise therapy + sham LLLT | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise therapy | Other |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 0, 3, 8, 26 and 52 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0, 3, 8, 26 and 52 weeks after randomization |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bergen | Bergen | 5018 | Norway |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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.
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| LLLT | Other | - 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. |
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| Sham LLLT | Other | - Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power). |
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| 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). | 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). | 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). | 8 weeks after randomization |
| Real time ultrasonography assessment of effusion | Maximum height will be measured. | 0, 3, 8, 26 and 52 weeks after randomization |
| Real time ultrasonography assessment of neovascularization | Doppler area will be measured. | 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 |
| 30 seconds chair stand | Last attempt counts if the participant is more than half way up. | 0, 3, 8, 26 and 52 weeks after randomization |
| Knee extension active range of motion | A 30 cm goniometer is used. | 0, 3, 8, 26 and 52 weeks after randomization |
| Knee flexion active range of motion | A 30 cm goniometer is used. | 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. | 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. | 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. | 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 |
| D012216 |
| Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D053685 | Laser Therapy |
| D010789 | Phototherapy |