Determining the Effectiveness of a New Phototherapy Treatment for the Knee Osteoarthritis
NCT ID: NCT04234685
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2018-11-08
2019-03-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analgesic Potential of Light Therapy in Knee Osteoarthritis
NCT05398666
Light Therapy and MRI Imaging for Knee Osteoarthritis Pain
NCT06395584
Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
NCT02388646
Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
NCT00375544
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
NCT06684587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HIPL Therapy™ group
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.
High Intensity Physio Light Therapy (HIPL Therapy™)
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.
Education
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 Exercise
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 Exercise
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 Control group
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.
Education
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 Exercise
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 Exercise
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™)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High Intensity Physio Light Therapy (HIPL Therapy™)
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.
Education
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 Exercise
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 Exercise
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™)
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Invitalize
UNKNOWN
Jordan Miller, PT, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jordan Miller, PT, PhD
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen's University
Kingston, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REH-708-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.