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

NCT04234685 | Completed

• 1 other identifier: REH-708-17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Through study completion (16 weeks)

Secondary Outcomes (10)

• Change in Sensitivity to Physical Activity (SPA)

  Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)

• Change in Physical Function

  Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)

• Change in Pain Intensity: VAS

  Each clinical visit (twice per week for four weeks)

• Change in Self-Reported Function

  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks

• Monitoring Exercise Adherence

  Through study completion (16 weeks)

Study Arms (2)

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.

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.

Behavioral: Education; Behavioral: Aerobic Exercise; Behavioral: Resistance Exercise; Device: Placebo Physio Light Therapy (HIPL Therapy™)

Interventions

High Intensity Physio Light Therapy (HIPL Therapy™) DEVICE

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.

Also known as: Invitalizer 2.0 (Invitalize, Kitchener Ontario)

HIPL Therapy™ group

Education BEHAVIORAL

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).

Also known as: Self-management, pain neurophysiology

HIPL Therapy™ group; Placebo Control group

Aerobic Exercise BEHAVIORAL

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.

Also known as: Walking program

HIPL Therapy™ group; Placebo Control group

Resistance Exercise BEHAVIORAL

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.

Also known as: Strength training, circuit training

HIPL Therapy™ group; Placebo Control group

Placebo Physio Light Therapy (HIPL Therapy™) DEVICE

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.

Also known as: Control

Placebo Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jordan Miller, PT, PhD: lead
• Invitalize: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 33292671 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Educational Status; Self-Management; Exercise; Resistance Training; Circuit-Based Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized 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. At this point the research assistant (physiotherapist) will open the sealed envelope, which will indicate either Group A or Group B, then initiate the phototherapy session by pressing on the corresponding button for Group A or B, which will deliver the appropriate phototherapy intensity for the respective group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: January 21, 2020
• Study Start: November 8, 2018
• Primary Completion: December 21, 2018
• Study Completion: March 19, 2019
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)