Osteoarthritis, KneeNCT04247893
Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
A study testing blood flow restriction and Photobiomodulation in people with Osteoarthritis, Knee and Physical Therapy Modalities, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Osteoarthritis, Knee, Physical Therapy Modalities
- What is being tested?
- blood flow restriction and Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2020to Dec 2022
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee pain to at least six months and minimum of 4 points in pain scale
- diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
Who cannot join
- Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- knee trauma;
- Cognitive impairment;
- Psychological disorder;
- Neurological disorder (sensory or motor);
- Cancer;
Show all 11Show fewer
- Diabetes any acute adverse health condition;
- Signs of hip OA;
- Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
- Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
- If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
Trial locations and contacts
1 site in 1 country.
About this study
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus. For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. A significance level of 5% will be adopted.
- Conditions
- Osteoarthritis, Knee, Physical Therapy Modalities
- Being tested
- blood flow restriction, Photobiomodulation, Placebo photobiomodulation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restrictionDevice
Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
PhotobiomodulationDevice
Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
Placebo photobiomodulationDevice
Placebo photobiomodulation - photobiomodulation device turned off.
| Study group | Role | What they receive |
|---|---|---|
| Exercises with blood flow restriction | Active comparator | Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted. Receives: Device: blood flow restriction |
| Exercises with blood flow restriction + photobiomodulation | Experimental | Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs. Receives: Device: blood flow restriction; Device: Photobiomodulation |
| Blood flow restriction exercises + placebo photobiomodulation | Placebo comparator | Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted. Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs. Receives: Device: blood flow restriction; Device: Placebo photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional pain
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Measured: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Stiffness
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Measured: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Physical functional
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Measured: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Secondary outcomes (5)
Intensity of pain
The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
Measured: Change from Baseline in The Numerical rating pain scale at 12 weeks
Functional capacity for sitting and standing
sitting-rising test
Measured: Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
Level of pressure pain
Pressure Pain Threshold in the knee with algometer dynamometer.
Measured: Change from Baseline in ThePressure Pain Threshold at 12 weeks
Muscle skin temperature
Infrared thermography, thermal imaging. Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
Measured: Change from Baseline in the muscle skin temperature at 12 weeks
Maximum voluntary isometric contraction
A portable dynamometer will be used to assess muscle contraction.
Measured: Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247893
- Sponsor's protocol ID
- 20123719.1.0000.5511
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04247893
- Acronym / sponsor ID
- 20123719.1.0000.5511
- Conditions
- Osteoarthritis, Knee, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Jan 2020 (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.
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus. For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. A significance level of 5% will be adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercises with blood flow restriction | Active comparator | Device: blood flow restrictionExercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted. |
| Exercises with blood flow restriction + photobiomodulation | Experimental | Device: blood flow restriction, Device: PhotobiomodulationExercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs. |
| Blood flow restriction exercises + placebo photobiomodulation | Placebo comparator | Device: blood flow restriction, Device: Placebo photobiomodulationExercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted. Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- knee pain to at least six months and minimum of 4 points in pain scale
- diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
Key exclusion criteria (11 listed)
- Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- knee trauma;
- Cognitive impairment;
- Psychological disorder;
- Neurological disorder (sensory or motor);
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 |
|---|---|---|
| blood flow restrictionOcclusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle. | Device | Blood flow restriction exercises + placebo photobiomodulation, Exercises with blood flow restriction, Exercises with blood flow restriction + photobiomodulation |
| PhotobiomodulationPhotobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons. | Device | Exercises with blood flow restriction + photobiomodulation |
| Placebo photobiomodulationPlacebo photobiomodulation - photobiomodulation device turned off. | Device | Blood flow restriction exercises + placebo photobiomodulation |
Primary outcome
Functional pain
Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Stiffness
Time frame: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Physical functional
Time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
5 secondary outcomes
Intensity of pain
Time frame: Change from Baseline in The Numerical rating pain scale at 12 weeks
Functional capacity for sitting and standing
Time frame: Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
Level of pressure pain
Time frame: Change from Baseline in ThePressure Pain Threshold at 12 weeks
Muscle skin temperature
Time frame: Change from Baseline in the muscle skin temperature at 12 weeks
Maximum voluntary isometric contraction
Time frame: Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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 blood flow restriction and Photobiomodulation in people with Osteoarthritis, Knee and Physical Therapy Modalities, run by University of Nove de Julho at 1 site in Brazil.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. 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 Brazil. 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?
Results are not available in the source record.
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?
Functional pain (time frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks). The study lists 3 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 31 Jan 2020.