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Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise therapy
LLLT
Sham LLLT
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Inflammation, Photobiomodulation, Low-level laser therapy, Double-blind, Randomized clinical trial, RCT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exercise therapy + LLLT

Exercise therapy + sham LLLT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

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).
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).
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).
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).
Real time ultrasonography assessment of effusion
Maximum height will be measured.
Real time ultrasonography assessment of neovascularization
Doppler area will be measured.
Real time ultrasonography assessment of femur cartilage thickness
30 seconds chair stand
Last attempt counts if the participant is more than half way up.
Knee extension active range of motion
A 30 cm goniometer is used.
Knee flexion active range of motion
A 30 cm goniometer is used.
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.
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.
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.
Analgesic drug consumption due to knee pain

Full Information

First Posted
November 6, 2018
Last Updated
November 24, 2021
Sponsor
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT03750279
Brief Title
Inflammatory Targeted Laser Treatment of Knee Osteoarthritis
Official Title
Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Inflammation, Photobiomodulation, Low-level laser therapy, Double-blind, Randomized clinical trial, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise therapy + LLLT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise therapy + sham LLLT
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
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
Intervention Name(s)
LLLT
Intervention Description
- 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
Intervention Name(s)
Sham LLLT
Intervention Description
- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Primary Outcome Measure Information:
Title
Pain on movement
Description
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.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Pain at night
Description
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.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Pain at rest
Description
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.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Pain in general
Description
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).
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Secondary Outcome Measure Information:
Title
Physical function in daily living
Description
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).
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Physical function in sports and recreational activities
Description
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).
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Quality of life
Description
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).
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Global health status assessment
Description
The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).
Time Frame
8 weeks after randomization
Title
Real time ultrasonography assessment of effusion
Description
Maximum height will be measured.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Real time ultrasonography assessment of neovascularization
Description
Doppler area will be measured.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Real time ultrasonography assessment of femur cartilage thickness
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
30 seconds chair stand
Description
Last attempt counts if the participant is more than half way up.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Knee extension active range of motion
Description
A 30 cm goniometer is used.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Knee flexion active range of motion
Description
A 30 cm goniometer is used.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Maximum pain free isometric quadriceps strength
Description
A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Joint line pain pressure threshold
Description
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.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Tibia bone pain pressure threshold
Description
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.
Time Frame
0, 3, 8, 26 and 52 weeks after randomization
Title
Analgesic drug consumption due to knee pain
Time Frame
0, 3, 8, 26 and 52 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Bergen
City
Bergen
ZIP/Postal Code
5018
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

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