Clinical trial NCT04234685: Determining the Effectiveness of a New Phototherapy Treatment for the Knee Osteoarthritis
Official title: Determining the Effectiveness of a Novel Phototherapy for the Treatment of Knee Osteoarthritis: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Invitalize
First posted: 2020-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double (patient and investigator) blind, parallel group, pilot randomized control trial with 1:1 allocation ratio to HIPL Therapy™ or placebo control.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Feasibility of Assessment Procedures: completion rate
timeFrame: Through study completion (16 weeks)
measure: Retention Rate
timeFrame: Through study completion (16 weeks)
measure: Feasibility of Research Assistant (RA) Training: rating
timeFrame: Baseline
measure: Monitoring Treatment Fidelity
timeFrame: Through study completion (16 weeks)
Secondary outcomes:
measure: Change in Sensitivity to Physical Activity (SPA)
timeFrame: Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)
measure: Change in Physical Function
timeFrame: Baseline, 2 weeks, 4 weeks (1st, 4th and 8th clinic visits)
measure: Change in Pain Intensity: VAS
timeFrame: Each clinical visit (twice per week for four weeks)
measure: Change in Self-Reported Function
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
measure: Monitoring Exercise Adherence
timeFrame: Through study completion (16 weeks)
measure: Global Rating of Change in Pain
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
measure: Global Rating of Change in Functional Abilities
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
measure: Global Rating of Change in Satisfaction with Care
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
measure: Change in Pressure Pain Threshold: Newtons (N)
timeFrame: Baseline and 4 weeks (1st and 8th clinic visits)
measure: Adverse Events
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
References:
citation: 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.