Inflammatory Targeted Laser Treatment of Knee Osteoarthritis
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 10/31/2018 |
| Pirmasis pateikimas: | 11/05/2018 |
| Numatytas registravimas pateiktas: | 11/19/2018 |
| Pirmas paskelbtas: | 11/22/2018 |
| Paskutinis atnaujinimas pateiktas: | 11/26/2018 |
| Paskutinis atnaujinimas paskelbtas: | 11/28/2018 |
| Faktinė studijų pradžios data: | 04/18/2018 |
| Numatoma pirminio užbaigimo data: | 10/18/2020 |
| Numatoma studijų užbaigimo data: | 01/18/2021 |
Būklė ar liga
Intervencija / gydymas
Other: Exercise therapy
Other: Exercise therapy + LLLT
Other: Exercise therapy + sham LLLT
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Active Comparator: Exercise therapy + 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. | Other: Exercise therapy + LLLT - 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. |
| Placebo Comparator: Exercise therapy + 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. | Other: Exercise therapy + sham LLLT - Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power). |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 50 Years Į 50 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Pain on movement [Change from baseline to week 3 and 8 and month 6 and 12]
2. Pain at night [Change from baseline to week 3 and 8 and month 6 and 12]
3. Pain at rest [Change from baseline to week 3 and 8 and month 6 and 12]
4. Pain in general [Change from baseline to week 3 and 8 and month 6 and 12]
Antrinės rezultatų priemonės
1. Physical function in daily living [Change from baseline to week 3 and 8 and month 6 and 12]
2. Physical function in sports and recreational activities [Change from baseline to week 3 and 8 and month 6 and 12]
3. Quality of life [Change from baseline to week 3 and 8 and month 6 and 12]
4. Global health status assessment [Week 8]
5. Real time ultrasonography assessment of effusion [Change from baseline to week 3 and 8 and month 6 and 12]
6. Real time ultrasonography assessment of neovascularization [Change from baseline to week 3 and 8 and month 6 and 12]
7. Real time ultrasonography assessment of femur cartilage thickness [Change from baseline to week 3 and 8 and month 6 and 12]
8. 30 seconds chair stand [Change from baseline to week 3 and 8 and month 6 and 12]
9. Knee extension active range of motion [Change from baseline to week 3 and 8 and month 6 and 12]
10. Knee flexion active range of motion [Change from baseline to week 3 and 8 and month 6 and 12]
11. Maximum pain free isometric quadriceps strength [Change from baseline to week 3 and 8 and month 6 and 12]
12. Joint line pain pressure threshold [Change from baseline to week 3 and 8 and month 6 and 12]
13. Tibia bone pain pressure threshold [Change from baseline to week 3 and 8 and month 6 and 12]
14. Analgesic drug consumption due to knee pain [Change from baseline to week 3 and 8 and month 6 and 12]
