Osteoarthritis, KneeNCT04234685
Determining the Effectiveness of a New Phototherapy Treatment for the Knee Osteoarthritis
A study testing High Intensity Physio Light Therapy (HIPL Therapy™), Education and Aerobic Exercise in people with Osteoarthritis, Knee, run by Jordan Miller, PT, PhD at 1 site in Canada.
Trial summary
Light therapy (phototherapy) has previously been shown to help reduce pain for people with musculoskeletal pain conditions, such as knee osteoarthritis (OA). A new phototherapy has been developed that allows for customizing the intensity of light based on patient characteristics, such as the patient size and skin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- High Intensity Physio Light Therapy (HIPL Therapy™), Education and Aerobic Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2018to 19 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking adults (>18 years of age)
- Provided with a diagnosis of knee OA by a physician
- Self-report of having experienced pain and disability related to knee OA for at least 6 months.
Who cannot join
- Skin conditions in which application of phototherapy may be contra-indicated (skin cancer, people receiving radiation therapy)
- History of total joint arthroplasty of the affected knee
- Red flags suggestive of non-musculoskeletal etiology (i.e. fever/chills, unrelenting night pain, multi-segmental or bilateral loss of sensation, sudden unexplained weight loss).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effectiveness of a Novel Phototherapy for the Treatment of Knee Osteoarthritis: a Pilot Randomized Controlled Trial
Light therapy (phototherapy) has previously been shown to help reduce pain for people with musculoskeletal pain conditions, such as knee osteoarthritis (OA). A new phototherapy has been developed that allows for customizing the intensity of light based on patient characteristics, such as the patient size and skin type. This new phototherapy approach needs to be evaluated to determine its effects. This study has been planned to determine how effective the new phototherapy is, but first it needs to be determined whether the study plans are feasible. This study will determine the feasibility of the full study by pilot testing the methods for the full trial with a group of 20 people with knee osteoarthritis. Participants will be randomly assigned to either receive the new phototherapy approach or a placebo phototherapy twice/week for four weeks. Pain and function will be measured over the four week treatment period and 12-weeks follow-up.
Read the detailed description
Invitalize has developed the High Intensity Physio Light (HIPL) Therapy™, a phototherapy method that utilizes an emission wavelength spectrum that has been identified for treatment of musculoskeletal disorders (MSD) such as OA.
Design: Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.
Recruitment: For the pilot, 20 adults who have been diagnosed with knee osteoarthritis (OA) of any duration will be recruited to participate in this study at Queen's University. Participants will be recruited from two primary care practices in Kingston, Ontario.
Randomization and allocation concealment: Participants will be randomized to either the placebo or control group using a computer generated random number generator. The allocation sequence will be recorded on cards placed in sealed, opaque envelopes. Allocation will be concealed until after the initial assessment is completed. Patients and investigators will remain blinded throughout the trial.
The HIPL Therapy™ group will receive phototherapy in addition to an education and exercise intervention with a physiotherapist twice weekly for four weeks. Participants will lay in a relaxed position on a therapy plinth with the light applied to the affected knee for 20 minutes. In the case of bilateral knee OA, the treatment time will be doubled and applied to both knees with an intensity setting aimed at delivering 150 mW/cm2.
The control group will receive the same education and exercise intervention, as well as 20 minutes of phototherapy twice weekly for four weeks. However, the intensity setting will be set at 5 mW/cm2, a dosage at which there is no therapeutic benefit expected, but the light will still be visible to the participant.
All participants will complete brief questionnaires at each visit and will complete functional assessments and pressure point testing at the initial, fourth and final visits. Participants will complete online questionnaires at the 8-, 12- and 16-week time points as well.
- Conditions
- Osteoarthritis, Knee
- Being tested
- High Intensity Physio Light Therapy (HIPL Therapy™), Education, Aerobic Exercise, Resistance Exercise, Placebo Physio Light Therapy (HIPL Therapy™)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Physio Light Therapy (HIPL Therapy™)Device
Also called Invitalizer 2.0 (Invitalize, Kitchener Ontario)
HIPL Therapy™ is an advanced phototherapy method that utilizes an emission wavelength spectrum that has been optimized for treatment of musculoskeletal disorders (MSD) such as OA.
EducationBehavioural
Also called Self-management, pain neurophysiology
Participants will take part in education on osteoarthritis, pain neurophysiology, and self-management strategies with the treating physiotherapist. The education will take place during the lab visits and will be brief (5-10 minutes at each session).
Aerobic ExerciseBehavioural
Also called Walking program
Participants will develop an individualized walking program. The goal will be to walk 30 minutes 5 times/week if able. For all participants who are unable to achieve this walking, they will be provided with a progressive walking program that starts at their baseline (the distance they can walk without being sore an hour later; and without feeling like they will be unable to perform their usual activities of daily living because of the walk). They will be encouraged to then progress by 10-20% each week. Participants will be asked to use a provided walking log to keep track of their progress.
Resistance ExerciseBehavioural
Also called Strength training, circuit training
Participants will also be instructed how to perform a series of six exercises: squat, step-up, lunge, single leg stance, knee flexion/extension, and resisted hamstring curl. The exercise technique and dosage will be tailored to the individual's current abilities. For example, if someone is unable to squat down to the level of a chair and return to standing, the chair height will be raised until the participant is able to perform the activity. The participants will begin by being asked to complete one set of 8-12 repetitions of each exercise, once daily, then progress to two or three sets daily as able. They will perform the exercises twice/week in the lab where they will receive support for problem solving and progression. Participants will be asked to use a provided exercise log to keep track of their progress.
Placebo Physio Light Therapy (HIPL Therapy™)Device
Also called Control
Phototherapy delivered at an intensity of 5 mW/cm2, a dosage at which there is no therapeutic benefit expected, but the light will still be visible to the participant.
| Study group | Role | What they receive |
|---|---|---|
| HIPL Therapy™ group | Experimental | All participants from both groups will take part in a standardized education and exercise intervention as suggested by best evidence. These sessions will be 20-30 minutes in length and will take place twice weekly for four weeks (8 sessions).
The HIPL Therapy™ group will receive phototherapy in addition to the education and exercise intervention twice weekly for four weeks. Participants will lay in a relaxed position on a therapy plinth with the light applied using the Invitalizer 2.0. The phototherapy will illuminate the affected knee for 20 minutes. In the case of bilateral knee OA, the treatment time will be doubled and applied to both knees. The knee will be positioned at a determined distance from the lamp with an intensity setting of 150 mW/cm2. Receives: Device: High Intensity Physio Light Therapy (HIPL Therapy™); Behavioral: Education; Behavioral: Aerobic Exercise; Behavioral: Resistance Exercise |
| Placebo Control group | Placebo comparator | All participants from both groups will take part in a standardized education and exercise intervention as suggested by best evidence. These sessions will be 20-30 minutes in length and will take place twice weekly for four weeks (8 sessions).
The placebo control group will also receive phototherapy in addition to the education and exercise intervention twice weekly for four weeks, in the same setting as the HIPL Therapy™ group and for the same duration. However, the intensity setting will be set at 5 mW/cm2, a dosage, at which there is no therapeutic benefit expected, but the light will still be visible to the participant. Receives: Behavioral: Education; Behavioral: Aerobic Exercise; Behavioral: Resistance Exercise; Device: Placebo Physio Light Therapy (HIPL Therapy™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
The feasibility of patient recruitment will be determined by the overall recruitment rate. The full trial will be considered feasible with our current recruitment methods if, during the pilot study, an average recruitment rate of at least 3 patients per week is achieved. This recruitment rate will allow us to exceed the 168 participants needed for a fully powered trial in a 56 week recruitment period. The findings of this study will inform whether this preliminary plan is feasible or if additional sites are needed.
Measured: Baseline
Feasibility of Assessment Procedures: completion rate
Feasibility of the assessment procedures will be measured by completion rate of outcome measures. As recommended for pilot studies, we set criteria a priori for acceptable completeness and considered >80% of all assessment items completed.
Measured: Through study completion (16 weeks)
Retention Rate
Retention will be assessed by attrition rate, with <20% attrition at 3-month follow-up (16 weeks) considered indicative of feasibility with our current protocol.
Measured: Through study completion (16 weeks)
Feasibility of Research Assistant (RA) Training: rating
Feasibility of training the RA who will implement the phototherapy intervention will be evaluated a rating of self-efficacy (0-10) for delivering the intervention, where a lower score would indicate a lower rating of preparedness for delivering the intervention and a higher score would indicate a higher rating of preparedness to deliver the intervention.
Measured: Baseline
Monitoring Treatment Fidelity
Fidelity was measured through an audit of the fidelity checklist and reported as a proportion of intervention components delivered in alignment with the protocol. An a-priori acceptable level of fidelity was considered 80% for each component of the intervention among participants that attend each visit.
Measured: Through study completion (16 weeks)
Secondary outcomes (10)
Change in Sensitivity to Physical Activity (SPA)
Change in SPA will be measured using the change in reported knee pain throughout the 6MWT. Pain intensity will be measured each minute throughout the 6MWT using a 100mm visual analogue scale (VAS) with anchors including no pain (0) to worst imaginable pain (100mm). The SPA index will be the difference between the peak pain intensity during the 6MWT and the baseline pain intensity at rest.
Pain during physical activity will be the primary outcome measure for the full trial, measured using the change in SPA.
Measured: Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)
Change in Physical Function
Change in physical function will be measured using the 6-minute walk test (6MWT). The 6MWT is a test of walking speed/aerobic capacity/endurance. It involves walking continuously on a 30-meter walkway for 6 minutes. The score on the test is the distance walked.
Measured: Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)
Change in Pain Intensity: VAS
Change in pain intensity will be measured using a 100mm visual analogue scale (VAS) with anchors including no pain (0) to worst imaginable pain (100mm). Participants will be asked to report their pain intensity at its worst in the past 24 hours, at its best in the past 24 hours, their average pain and their pain right now.
Measured: Each clinical visit (twice per week for four weeks)
Change in Self-Reported Function
Change in self-reported function - physical function will be measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale (0 to 68) with higher scores indicating greater functional limitations. The WOMAC physical function subscale uses a series of questions about functional tasks answered on a four-point Likert scale.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Monitoring Exercise Adherence
Adherence to prescribed exercise will be measured using a self-report diary of all exercises prescribed.
Measured: Through study completion (16 weeks)
Global Rating of Change in Pain
Global rating of change in pain will be measured using an 11-point global rating of change (GROC) scale (-5 to +5, where -5 is much worse and +5 is much better), as has been recommended in the literature for self-reported rating of change
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Global Rating of Change in Functional Abilities
Global rating of change in functional abilities will be measured using an 11-point global rating of change (GROC) scale (-5 to +5, where -5 is much worse and +5 is much better), as has been recommended in the literature for self-reported rating of change
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Global Rating of Change in Satisfaction with Care
Global rating of change in satisfaction with care will be measured using an 11-point global rating of change (GROC) scale (-5 to +5, where -5 is very dissatisfied and +5 is very satisfied), as has been recommended in the literature for self-reported rating of change
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Change in Pressure Pain Threshold: Newtons (N)
Change in pressure pain threshold will be assessed as follows: pressure will be applied at nine predetermined points around the knee using a handheld pressure algometer. Participants will be asked to report the moment the pressure switches from comfortable pressure to slightly unpleasant pain. The pressure pain threshold will be recorded in Newtons (N). This is measured as a process outcome to determine if it relates to SPA.
Measured: Baseline and 4 weeks (1st and 8th clinic visits)
Adverse Events
Adverse events will be recorded using an adverse events questionnaire that is reported consistently with reporting guidelines and asks: 1) if the patient has experienced any events as a result of any of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) How severe the adverse event was (0-10 scale); 4) what adverse events were experienced. Any serious adverse events will be addressed immediately by referral to the most appropriate member of the primary health care team.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start8 Nov 2018
- Primary completion21 Dec 2018
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Miller, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Invitalize
- Responsible party
- Sponsor-investigator, Jordan Miller, PT, PhD, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234685
- Sponsor's protocol ID
- REH-708-17
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2019
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vader K, Abebe AB, Chala MB, Varette K, Miller J. Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Nov 26;6(1):186. doi: 10.1186/s40814-020-00729-4.
PubMed 33292671
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of a Novel Phototherapy for the Treatment of Knee Osteoarthritis: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04234685
- Acronym / sponsor ID
- REH-708-17
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jordan Miller, PT, PhDUniversity, hospital or other
- Collaborators
- Invitalize
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 21 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.
Light therapy (phototherapy) has previously been shown to help reduce pain for people with musculoskeletal pain conditions, such as knee osteoarthritis (OA). A new phototherapy has been developed that allows for customizing the intensity of light based on patient characteristics, such as the patient size and skin type. This new phototherapy approach needs to be evaluated to determine its effects. This study has been planned to determine how effective the new phototherapy is, but first it needs to be determined whether the study plans are feasible. This study will determine the feasibility of the full study by pilot testing the methods for the full trial with a group of 20 people with knee osteoarthritis. Participants will be randomly assigned to either receive the new phototherapy approach or a placebo phototherapy twice/week for four weeks. Pain and function will be measured over the four week treatment period and 12-weeks follow-up.
Detailed description
Invitalize has developed the High Intensity Physio Light (HIPL) Therapy™, a phototherapy method that utilizes an emission wavelength spectrum that has been identified for treatment of musculoskeletal disorders (MSD) such as OA.
Design: Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.
Recruitment: For the pilot, 20 adults who have been diagnosed with knee osteoarthritis (OA) of any duration will be recruited to participate in this study at Queen's University. Participants will be recruited from two primary care practices in Kingston, Ontario.
Randomization and allocation concealment: Participants will be randomized to either the placebo or control group using a computer generated random number generator. The allocation sequence will be recorded on cards placed in sealed, opaque envelopes. Allocation will be concealed until after the initial assessment is completed. Patients and investigators will remain blinded throughout the trial.
The HIPL Therapy™ group will receive phototherapy in addition to an education and exercise intervention with a physiotherapist twice weekly for four weeks. Participants will lay in a relaxed position on a therapy plinth with the light applied to the affected knee for 20 minutes. In the case of bilateral knee OA, the treatment time will be doubled and applied to both knees with an intensity setting aimed at delivering 150 mW/cm2.
The control group will receive the same education and exercise intervention, as well as 20 minutes of phototherapy twice weekly for four weeks. However, the intensity setting will be set at 5 mW/cm2, a dosage at which there is no therapeutic benefit expected, but the light will still be visible to the participant.
All participants will complete brief questionnaires at each visit and will complete functional assessments and pressure point testing at the initial, fourth and final visits. Participants will complete online questionnaires at the 8-, 12- and 16-week time points as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.
| Arm | Type | Receives |
|---|---|---|
| HIPL Therapy™ group | Experimental | Device: High Intensity Physio Light Therapy (HIPL Therapy™), Behavioral: Education, Behavioral: Aerobic Exercise, Behavioral: Resistance ExerciseAll participants from both groups will take part in a standardized education and exercise intervention as suggested by best evidence. These sessions will be 20-30 minutes in length and will take place twice weekly for four weeks (8 sessions). The HIPL Therapy™ group will receive phototherapy in addition to the education and exercise intervention twice weekly for four weeks. Participants will lay in a relaxed position on a therapy plinth with the light applied using the Invitalizer 2.0. The phototherapy will illuminate the affected knee for 20 minutes. In the case of bilateral knee OA, the treatment time will be doubled and applied to both knees. The knee will be positioned at a determined distance from the lamp with an intensity setting of 150 mW/cm2. |
| Placebo Control group | Placebo comparator | Behavioral: Education, Behavioral: Aerobic Exercise, Behavioral: Resistance Exercise, Device: Placebo Physio Light Therapy (HIPL Therapy™)All participants from both groups will take part in a standardized education and exercise intervention as suggested by best evidence. These sessions will be 20-30 minutes in length and will take place twice weekly for four weeks (8 sessions). The placebo control group will also receive phototherapy in addition to the education and exercise intervention twice weekly for four weeks, in the same setting as the HIPL Therapy™ group and for the same duration. However, the intensity setting will be set at 5 mW/cm2, a dosage, at which there is no therapeutic benefit expected, but the light will still be visible to the participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking adults (>18 years of age)
- Provided with a diagnosis of knee OA by a physician
- Self-report of having experienced pain and disability related to knee OA for at least 6 months.
Key exclusion criteria (3 listed)
- Skin conditions in which application of phototherapy may be contra-indicated (skin cancer, people receiving radiation therapy)
- History of total joint arthroplasty of the affected knee
- Red flags suggestive of non-musculoskeletal etiology (i.e. fever/chills, unrelenting night pain, multi-segmental or bilateral loss of sensation, sudden unexplained weight loss).
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 |
|---|---|---|
| High Intensity Physio Light Therapy (HIPL Therapy™)Also: Invitalizer 2.0 (Invitalize, Kitchener Ontario)HIPL Therapy™ is an advanced phototherapy method that utilizes an emission wavelength spectrum that has been optimized for treatment of musculoskeletal disorders (MSD) such as OA. | Device | HIPL Therapy™ group |
| EducationAlso: Self-management, pain neurophysiologyParticipants will take part in education on osteoarthritis, pain neurophysiology, and self-management strategies with the treating physiotherapist. The education will take place during the lab visits and will be brief (5-10 minutes at each session). | Behavioural | HIPL Therapy™ group, Placebo Control group |
| Aerobic ExerciseAlso: Walking programParticipants will develop an individualized walking program. The goal will be to walk 30 minutes 5 times/week if able. For all participants who are unable to achieve this walking, they will be provided with a progressive walking program that starts at their baseline (the distance they can walk without being sore an hour later; and without feeling like they will be unable to perform their usual activities of daily living because of the walk). They will be encouraged to then progress by 10-20% each week. Participants will be asked to use a provided walking log to keep track of their progress. | Behavioural | HIPL Therapy™ group, Placebo Control group |
| Resistance ExerciseAlso: Strength training, circuit trainingParticipants will also be instructed how to perform a series of six exercises: squat, step-up, lunge, single leg stance, knee flexion/extension, and resisted hamstring curl. The exercise technique and dosage will be tailored to the individual's current abilities. For example, if someone is unable to squat down to the level of a chair and return to standing, the chair height will be raised until the participant is able to perform the activity. The participants will begin by being asked to complete one set of 8-12 repetitions of each exercise, once daily, then progress to two or three sets daily as able. They will perform the exercises twice/week in the lab where they will receive support for problem solving and progression. Participants will be asked to use a provided exercise log to keep track of their progress. | Behavioural | HIPL Therapy™ group, Placebo Control group |
| Placebo Physio Light Therapy (HIPL Therapy™)Also: ControlPhototherapy delivered at an intensity of 5 mW/cm2, a dosage at which there is no therapeutic benefit expected, but the light will still be visible to the participant. | Device | Placebo Control group |
Primary outcome
Recruitment Rate
Time frame: Baseline
The feasibility of patient recruitment will be determined by the overall recruitment rate. The full trial will be considered feasible with our current recruitment methods if, during the pilot study, an average recruitment rate of at least 3 patients per week is achieved. This recruitment rate will allow us to exceed the 168 participants needed for a fully powered trial in a 56 week recruitment period. The findings of this study will inform whether this preliminary plan is feasible or if additional sites are needed.
Feasibility of Assessment Procedures: completion rate
Time frame: Through study completion (16 weeks)
Feasibility of the assessment procedures will be measured by completion rate of outcome measures. As recommended for pilot studies, we set criteria a priori for acceptable completeness and considered >80% of all assessment items completed.
Retention Rate
Time frame: Through study completion (16 weeks)
Retention will be assessed by attrition rate, with <20% attrition at 3-month follow-up (16 weeks) considered indicative of feasibility with our current protocol.
Feasibility of Research Assistant (RA) Training: rating
Time frame: Baseline
Feasibility of training the RA who will implement the phototherapy intervention will be evaluated a rating of self-efficacy (0-10) for delivering the intervention, where a lower score would indicate a lower rating of preparedness for delivering the intervention and a higher score would indicate a higher rating of preparedness to deliver the intervention.
Monitoring Treatment Fidelity
Time frame: Through study completion (16 weeks)
Fidelity was measured through an audit of the fidelity checklist and reported as a proportion of intervention components delivered in alignment with the protocol. An a-priori acceptable level of fidelity was considered 80% for each component of the intervention among participants that attend each visit.
10 secondary outcomes
Change in Sensitivity to Physical Activity (SPA)
Time frame: Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)
Change in Physical Function
Time frame: Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)
Change in Pain Intensity: VAS
Time frame: Each clinical visit (twice per week for four weeks)
Change in Self-Reported Function
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Monitoring Exercise Adherence
Time frame: Through study completion (16 weeks)
Global Rating of Change in Pain
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Global Rating of Change in Functional Abilities
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Global Rating of Change in Satisfaction with Care
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Change in Pressure Pain Threshold: Newtons (N)
Time frame: Baseline and 4 weeks (1st and 8th clinic visits)
Adverse Events
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
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 20 Mar 2025.
- Derived from this study: PubMed 33292671Vader K, Abebe AB, Chala MB, Varette K, Miller J. Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Nov 26;6(1):186. doi: 10.1186/s40814-020-00729-4.
- 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 High Intensity Physio Light Therapy (HIPL Therapy™), Education and Aerobic Exercise in people with Osteoarthritis, Knee, run by Jordan Miller, PT, PhD at 1 site in Canada.
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 3 inclusion and 3 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 20 Mar 2025. 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 Canada. 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?
Recruitment Rate (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234685, which also lists 1 linked publication.
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 20 Mar 2025.