Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750279
• Other study ID #: Bergen KOA laser RCT
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: August 24, 2021

Study information

• Verified date: November 2021
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exercise 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.
• 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.
• Sham LLLT
- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Real time ultrasonography assessment of effusion	Maximum height will be measured.	0, 3, 8, 26 and 52 weeks after randomization
Secondary	Real time ultrasonography assessment of neovascularization	Doppler area will be measured.	0, 3, 8, 26 and 52 weeks after randomization
Secondary	Real time ultrasonography assessment of femur cartilage thickness		0, 3, 8, 26 and 52 weeks after randomization
Secondary	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
Secondary	Knee extension active range of motion	A 30 cm goniometer is used.	0, 3, 8, 26 and 52 weeks after randomization
Secondary	Knee flexion active range of motion	A 30 cm goniometer is used.	0, 3, 8, 26 and 52 weeks after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	Analgesic drug consumption due to knee pain		0, 3, 8, 26 and 52 weeks after randomization