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Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

NCT ID: NCT03750279

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2021-08-24

Brief Summary

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

Detailed Description

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Conditions

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Knee Osteoarthritis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exercise therapy

Intervention Type 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.

LLLT

Intervention Type 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 + 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.

Group Type PLACEBO_COMPARATOR

Exercise therapy

Intervention Type 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.

Sham LLLT

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Sham LLLT

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Bergen

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Bergen KOA laser RCT

Identifier Type: -

Identifier Source: org_study_id