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Completed

NCT Number: NCT03750279

Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

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

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, 5018, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Sham LLLT

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

Primary outcomes

  1. Pain on movement

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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.

  2. Pain at night

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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.

  3. Pain at rest

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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.

  4. Pain in general

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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 outcomes

  1. Physical function in daily living

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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).

  2. Physical function in sports and recreational activities

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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).

  3. Quality of life

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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).

  4. Global health status assessment

    Time frame: 8 weeks after randomization

    The participants evaluate their change from baseline in terms of symptoms in general from 1 to 7 (1, no symptoms; 7, worse than ever).

  5. Real time ultrasonography assessment of effusion

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    Maximum height will be measured.

  6. Real time ultrasonography assessment of neovascularization

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    Doppler area will be measured.

  7. Real time ultrasonography assessment of femur cartilage thickness

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

  8. 30 seconds chair stand

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    Last attempt counts if the participant is more than half way up.

  9. Knee extension active range of motion

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    A 30 cm goniometer is used.

  10. Knee flexion active range of motion

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    A 30 cm goniometer is used.

  11. Maximum pain free isometric quadriceps strength

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    A dynamometer is used: The dynamometer display is not visible during the procedure in order to blind the assessor for the level of pressure.

  12. Joint line pain pressure threshold

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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.

  13. Tibia bone pain pressure threshold

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

    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.

  14. Analgesic drug consumption due to knee pain

    Time frame: 0, 3, 8, 26 and 52 weeks after randomization

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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