Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

NCT03750279 | Completed

• 1 other identifier: Bergen KOA laser RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Inflammation; Photobiomodulation; Low-level laser therapy; Double-blind; Randomized clinical trial; RCT

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Physical function in daily living

  0, 3, 8, 26 and 52 weeks after randomization

• Physical function in sports and recreational activities

  0, 3, 8, 26 and 52 weeks after randomization

• Quality of life

  0, 3, 8, 26 and 52 weeks after randomization

• Global health status assessment

  8 weeks after randomization

• Real time ultrasonography assessment of effusion

  0, 3, 8, 26 and 52 weeks after randomization

Study Arms (2)

Exercise therapy + LLLT

ACTIVE COMPARATOR

* 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; Other: LLLT

Exercise therapy + sham LLLT

PLACEBO COMPARATOR

* 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; Other: Sham LLLT

Interventions

Exercise therapy OTHER

* 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.

Exercise therapy + LLLT; Exercise therapy + sham LLLT

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.

Exercise therapy + LLLT

Sham LLLT OTHER

\- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).

Exercise therapy + sham LLLT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

University of Bergen

Bergen, 5018, Norway

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Inflammation

Interventions

Exercise Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Laser Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 23, 2018
• Study Start: April 19, 2018
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)