Knee OsteoarthritisNCT03750279
Inflammatory Targeted Laser Treatment of Knee Osteoarthritis
A study testing Exercise therapy and LLLT in people with Knee Osteoarthritis, run by University of Bergen at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise therapy and LLLT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 19 Apr 2018to 24 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise therapy, LLLT, Sham LLLT
- Keywords
- Knee osteoarthritis, Inflammation, Photobiomodulation, Low-level laser therapy, Double-blind, Randomized clinical trial, RCT
- Medical subject headings
- Osteoarthritis, Knee, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
- 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.
LLLTOther
- 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 LLLTOther
- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise therapy; Other: Sham LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Secondary outcomes (14)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 weeks after randomization
Real time ultrasonography assessment of effusion
Maximum height will be measured.
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Real time ultrasonography assessment of neovascularization
Doppler area will be measured.
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Real time ultrasonography assessment of femur cartilage thickness
Measured: 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.
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Knee extension active range of motion
A 30 cm goniometer is used.
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Knee flexion active range of motion
A 30 cm goniometer is used.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Analgesic drug consumption due to knee pain
Measured: 0, 3, 8, 26 and 52 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start19 Apr 2018
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750279
- Sponsor's protocol ID
- Bergen KOA laser RCT
- Status last verified
- Nov 2021
- First submitted
- 6 Nov 2018
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Targeted Low-level Laser Treatment of Knee Osteoarthritis - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03750279
- Acronym / sponsor ID
- Bergen KOA laser RCT
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Inflammation, Photobiomodulation, Low-level laser therapy, Double-blind, Randomized clinical trial, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy + LLLT | Active comparator | Other: Exercise therapy, Other: 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. |
| Exercise therapy + sham LLLT | Placebo comparator | Other: Exercise therapy, Other: 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Knee alloplastic
- Total meniscectomy
- Intra-articular steroid injection and/or oral steroid treatment within the last six months
- Cancer
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Exercise therapy + LLLT, Exercise therapy + sham LLLT |
| 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. | Other | Exercise therapy + LLLT |
| Sham LLLT- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power). | Other | Exercise therapy + sham LLLT |
Primary outcome
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.
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.
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.
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).
14 secondary outcomes
Physical function in daily living
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Physical function in sports and recreational activities
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Quality of life
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Global health status assessment
Time frame: 8 weeks after randomization
Real time ultrasonography assessment of effusion
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Real time ultrasonography assessment of neovascularization
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Real time ultrasonography assessment of femur cartilage thickness
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
30 seconds chair stand
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Knee extension active range of motion
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Knee flexion active range of motion
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Maximum pain free isometric quadriceps strength
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Joint line pain pressure threshold
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Tibia bone pain pressure threshold
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Analgesic drug consumption due to knee pain
Time frame: 0, 3, 8, 26 and 52 weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy and LLLT in people with Knee Osteoarthritis, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on movement (time frame: 0, 3, 8, 26 and 52 weeks after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.