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Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliKuajiri
Wadhamini
University of Bergen

Maneno muhimu

Kikemikali

This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct to exercise therapy in knee osteoarthritis (KOA).

Tarehe

Imethibitishwa Mwisho: 10/31/2018
Iliyowasilishwa Kwanza: 11/05/2018
Uandikishaji uliokadiriwa Uliwasilishwa: 11/19/2018
Iliyotumwa Kwanza: 11/22/2018
Sasisho la Mwisho Liliwasilishwa: 11/26/2018
Sasisho la Mwisho Lilichapishwa: 11/28/2018
Tarehe halisi ya kuanza kwa masomo: 04/18/2018
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 10/18/2020
Tarehe ya Kukamilisha Utafiti: 01/18/2021

Hali au ugonjwa

Knee Osteoarthritis

Uingiliaji / matibabu

Other: Exercise therapy

Other: Exercise therapy + LLLT

Other: Exercise therapy + sham LLLT

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
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).

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 50 Years Kwa 50 Years
Jinsia Inastahiki KujifunzaAll
Hupokea Wajitolea wa AfyaNdio
Vigezo

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

Matokeo

Hatua za Matokeo ya Msingi

1. Pain on movement [Change from baseline to week 3 and 8 and month 6 and 12]

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.

2. Pain at night [Change from baseline to week 3 and 8 and month 6 and 12]

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.

3. Pain at rest [Change from baseline to week 3 and 8 and month 6 and 12]

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.

4. Pain in general [Change from baseline to week 3 and 8 and month 6 and 12]

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).

Hatua za Matokeo ya Sekondari

1. Physical function in daily living [Change from baseline to week 3 and 8 and month 6 and 12]

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).

2. Physical function in sports and recreational activities [Change from baseline to week 3 and 8 and month 6 and 12]

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).

3. Quality of life [Change from baseline to week 3 and 8 and month 6 and 12]

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).

4. Global health status assessment [Week 8]

The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).

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]

Doppler activity.

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]

Last attempt counts if the participant is more than half way up.

9. Knee extension active range of motion [Change from baseline to week 3 and 8 and month 6 and 12]

A 30 cm goniometer is used.

10. Knee flexion active range of motion [Change from baseline to week 3 and 8 and month 6 and 12]

A 30 cm goniometer is used.

11. Maximum pain free isometric quadriceps strength [Change from baseline to week 3 and 8 and month 6 and 12]

A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.

12. Joint line pain pressure threshold [Change from baseline to week 3 and 8 and month 6 and 12]

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.

13. Tibia bone pain pressure threshold [Change from baseline to week 3 and 8 and month 6 and 12]

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.

14. Analgesic drug consumption due to knee pain [Change from baseline to week 3 and 8 and month 6 and 12]

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