Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

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

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Exercise therapy; Other: LLLT; Other: Sham LLLT

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5018
    • University of Bergen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other: 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; 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.; Other: Sham LLLT; - Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): August 24, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Randomized clinical trial; Double-blind; Knee osteoarthritis; RCT; Photobiomodulation; Low-level laser therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Bergen KOA laser RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No