NCT04234685

Determining the Effectiveness of a New Phototherapy Treatment for the Knee Osteoarthritis

Determining the Effectiveness of a Novel Phototherapy for the Treatment of Knee Osteoarthritis: a Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jordan Miller, PT, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	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).
BEHAVIORAL	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.
BEHAVIORAL	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.
DEVICE	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.

Timeline

• Start date: 2018-11-08
• Primary completion: 2018-12-21
• Completion: 2019-03-19
• First posted: 2020-01-21
• Last updated: 2025-03-20

Locations

1 site across 1 country: Canada