Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001331729
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
17/10/2022
Date last updated
17/01/2024
Date data sharing statement initially provided
17/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of light-therapy on pain and mobility in people with knee joint osteoarthritis.
Scientific title
An Investigation of the effects of Photobiomodulation therapy on Pain and functional Mobility in people with knee osteoarthritis not awaiting knee replacement surgery (a pilot study with wait-list control)
Secondary ID [1] 307814 0
None
Universal Trial Number (UTN)
Trial acronym
The iPPaM study
Linked study record
ACTRN12622000051741
This pilot study focuses on a subset of people who may not yet be eligible for knee replacement surgery thus not eligible for the primary study.
This protocol has been modified from, yet is fundamentally based on the primary study.

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 327400 0
Condition category
Condition code
Musculoskeletal 324528 324528 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is photobiomodulation (PBM) or light therapy applied using a novel light patch system.

CareWear is a novel, 3-D printed self-adhesive patch with hundreds of micro-diodes (light emitting diodes are found in many home appliances) that emit specific light frequencies that have been found in other research to reduce inflammation and pain. The CareWear patch is registered in the USA and with the Australian Therapeutic Goods Administration (TGA) for applying light to areas of pain and inflammation.

Consenting participants will be loaned a CareWear kit and visited at home to be shown how to apply the light patches to the knee to be operated on. The light patch treatment period lasts for 2 weeks. The waitlist control group will not receive the light therapy.

All participants will be evaluated with objective measures and questionnaires at 3 time points: Baseline assessment, 2 weeks after baseline, and at 6 months.
The active group will be evaluated an additional 4 times: at 1 week after commencement of light therapy, and at 2,4, and 6 weeks after the end of light therapy treatment.

Participants will be shown how to self-apply the patches to standardised positions over the large muscle at the front of the thigh, behind the knee, and either side of the knee at each treatment. Patches are removed following each 30-minute daily treatment.

Treatment shall be applied with the participant comfortably seated and the knee extended and supported (e.g., on a lounge or bed) to accommodate the popliteal fossa light patch behind the knee.

Participants will be provided with contact details and asked to call the researcher if they have any questions or concerns during the home application period.

Participants will be contacted by telephone between appointments; and adherence to treatment is recorded on the treatment device (from which unidentifiable use data can be downloaded).

The parameters of the light patches are:
- Pulse Frequency: 33KHz
- Wavelength: Combined 450nm (blue light) and 640nm (red light)
- Peak optical power: 6.75 mW/cm2 (450 nm); 2.25 mW/cm2 (640 nm)
- Pulse duration/interval: 10 microsec/20 microsec
- Radiant exposure (dose): 4.5 J/cm2
Intervention code [1] 324281 0
Treatment: Devices
Comparator / control treatment
The control treatment is NO light therapy.
Control participants will only be offered light therapy if deemed appropriate by the treating physiotherapist once the patient has entered the usual treatment phase of the study.
The usual treatment phase is entered by study participants once they are accepted for physiotherapy from the physiotherapy department waitlist.
The study has been designed to have the intervention phase occur whilst the patients are on the physiotherapy department waitlist.
Control group
Active

Outcomes
Primary outcome [1] 332358 0
Change in numeric pain rating scale (NPRS)
Timepoint [1] 332358 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [1] 413183 0
30 second Timed Stands (chair stand) test to assess physical function, dynamic balance and pain
Timepoint [1] 413183 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [2] 413184 0
40m fast-paced walk test to assess pain, walking speed over a short distance, and changing direction whilst walking
Timepoint [2] 413184 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [3] 413185 0
Timed Up-and-Go test to assess functional mobility, balance and pain
Timepoint [3] 413185 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [4] 413186 0
Western Ontario and McMaster Universities Arthritis Index (WOMAC) knee score to assess pain, stiffness and physical function
Timepoint [4] 413186 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.
Secondary outcome [5] 413187 0
Hospital anxiety and depression scale (HADS)
Timepoint [5] 413187 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.
Secondary outcome [6] 413232 0
European Quality of Life Five Dimension questionnaire (EQ-5D-5L)
Timepoint [6] 413232 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.
Secondary outcome [7] 413234 0
International Physical Activity Questionnaire (IPAQ)
Timepoint [7] 413234 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [8] 413235 0
Video recordings and gait analyses of the 40m fast paced walk test (FPWT), and Timed-Up-and-Go (TUG) test, as composite secondary outcome.
Participants will be video recorded performing the TUG test from a lateral view and from a posterior/anterior view for the 40m FPWT.
Blinded assessors will independently assess gait using 20 scaled criteria from the Rivermead Visual Gait Assessment tool.
The assessors may re-play the recordings as needed to confirm their opinion/s for each gait criterion from both sets of recordings.
Gait assessment criteria include:
Upper limb position, stance and swing phase postural factors (such as displacement of trunk and pelvis), hip, knee and ankle joint position, use of walking aid,
(Lord, Halligan and Wade. ‘Visual gait analysis: the development of a clinical assessment and scale’. Clinical Rehabilitation 1998; 12: 107-119)
Timepoint [8] 413235 0
- First baseline assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
Secondary outcome [9] 414126 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [9] 414126 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.
Secondary outcome [10] 414127 0
Knee joint range of motion (flexion and passive/active extension) using standard goniometer
Timepoint [10] 414127 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [11] 414128 0
Quadriceps muscle strength using manual muscle testing
Timepoint [11] 414128 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

And additionally for the Treatment Group, at:
- one week after commencement of light therapy, and at
- 2, 4, and 6 weeks after the end of light therapy treatment.
Secondary outcome [12] 414129 0
Consumption of analgesic medications (by study diary)
Timepoint [12] 414129 0
For all participants:
- Daily participant diary during first fortnight of study
- At the 6-month follow-up session, participants will be asked about use of any analgesics in the previous week.

Treatment group participants:
In the 6-week post-intervention phase follow-up period, participants will be asked to record their pain and medication use in their study diary, twice/week, when at rest, on moving in bed, when standing, and when walking. Participants will be sent a SMS text reminder to do so.
Secondary outcome [13] 414130 0
Willingness to engage in a program of exercise.
Participants will be asked to nominate a specific functional goal (e.g., “I’d like to be able to walk to and from the corner store for milk and bread”).
All participants will be assessed using two global assessment questions:
1) Mark on the scale how you feel right now about doing a program of knee exercises (such as light weights, squats) prescribed by your physiotherapist to attain your goal:
0 (Not at all willing to do any knee exercises) >>> 3 (I would consider doing a program of knee exercises) >>> 7 (I have started doing some knees exercises) >>> 10 (I am happily doing a program of knee exercises)
2) Mark on the scale how you feel right now about doing a physical activity program (such as walking, cycling, swimming etc) to attain your goal:
0 (Not at all willing to do any physical activity) >>> 3 (I would consider doing a physical activity program) >>> 7 (I have started doing some physical activity) >>> 10 (I am happily doing a physical activity program
Timepoint [13] 414130 0
All participants:
- Baseline: First assessment (prior to the initiation of light therapy, or equivalent for no treatment control participants).
- 2 weeks following the baseline assessment
- 6 months following the baseline assessment.

Eligibility
Key inclusion criteria
Pain and decreased function & mobility, associated with the presence of knee osteoarthritis (KOA).

- Evidence confirming KOA as diagnosed by a medical practitioner or Orthopaedic Surgeon
- Not suitable for surgical intervention of the affected knee
Minimum age
50 Years
Maximum age
87 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Coagulopathy
- Pre-existing pain syndrome such as peripheral neuropathy
- Previous history of stroke
- Previous surgery/severe trauma of the operated knee
- Neuromuscular disease significantly affecting the operated knee
- Severe back pain and arthritis significantly affecting mobility or referring pain to the operated leg
- Significant cognitive dysfunction that may prevent ability to comply with testing or to consent to participation in the study (people of a non-English speaking background will NOT be excluded if a reliable interpreter will be available to assist with explaining the study requirements, taking part in outcome questionnaires etc)
- Medical diagnosis of significant mental ill health (e.g., severe depression, anxiety, catastrophising etc) which may impact upon compliance with testing procedures
- Photosensitising agents (drugs)
- Tumour at the knee or thigh where patches will be applied
- Skin sensitivity to medical adhesives


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation to either intervention or control groups will occur after screening and consent has been undertaken.
Patient allocation sequences will be generated using an online study randomization platform (Sealed Envelope Ltd. 2021. Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists) so that the research assistant determining participant eligibility for inclusion in the study is unaware, when the decision was made, to which group the participant would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation will be carried out using a table created by computerised sequence generation. Patient allocation sequences will be generated using the online study randomization platform, Sealed Envelope Ltd. 2021.
Available from: www.sealedenvelope.com/simple-randomiser/v1/lists
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot study, we have not undertaken a power analysis. A power calculation will occur should results suggest that we could progress to a larger RCT.

For all assessments and where data is available, the statistical differences between the intervention group and control group will be assessed by t-tests for comparisons between PROM scores, and time taken to complete functional measures (timed stand, 40m fast walk, and timed-up-and-go tests).

Data will be analysed initially using Excel. Descriptive statistics (including means and standard deviations) will be used to summarise continuous data. Categorical data will be summarised using frequencies and percentages. Assuming a normal distribution of the group samples, we will compare the means between groups utilising an independent samples t-test; and paired sample t-tests to compare within group differences between different time points. We do not expect sufficient power to determine p-values but we expect to be able to make some basic observations regarding the relationship of the intervention outcomes in the treatment group compared to the no treatment control group; and between the start and end of the intervention phase and with the follow-up time points.

1. To determine whether photobiomodulation (PBM) alters pain compared to control:

Changes in pain determined using an incremental NPRS will be expressed as a percentage change of baseline values of pain at the first timepoint compared to subsequent time points per participant. A change on the NPRS of 20% between two timepoints will be considered clinically significant. For each comparative time point with baseline values, each participant per intervention will be categorised into either <20% pain difference, >20% negative pain difference, and >20% positive pain difference.


2. To determine whether PBM alters the pattern of use of analgesia in intervention compared to control group (oral or topical analgesic usage, either self-prescribed or medically prescribed):

Where possible (i.e., if participants are using opioid-based analgesics) total morphine-equivalent concentration will be expressed as the mean + SD respectively, compared between the active treatment group and the control group; and between the start and the end of the intervention phase. Where other forms of analgesia are being used by participants, total amounts per day will be calculated and compared between the active treatment group and the control group; and between the start and the end of the intervention phase (or equivalent). Use of analgesics at all time points will be reported descriptively as means and standard deviations.


3. To determine whether PBM alters participant-reported outcome measures, knee range of motion and function compared to control no treatment:

For the patient-reported outcome measures (PROMs) from each group, the average scores for the assessment will be expressed as the mean + SD and compared between groups (intervention group, and control group). Similarly, changes in maximum knee flexion and extension in degrees will be calculated using goniometry and compared between groups.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2022
Actual
14/04/2023
Date of last participant enrolment
Anticipated
26/04/2024
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
20
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312083 0
Charities/Societies/Foundations
Name [1] 312083 0
Mater Foundation
Country [1] 312083 0
Australia
Primary sponsor type
Individual
Name
Dr Liisa Laakso
Address
Mater Research,
Aubigny Place,
Raymond Terrace , South Brisbane, Queensland 4101
Country
Australia
Secondary sponsor category [1] 313601 0
Other
Name [1] 313601 0
Mater Research
Address [1] 313601 0
Mater Research
Aubigny Place,
Raymond Terrace, South Brisbane Queensland 4101
Country [1] 313601 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311491 0
Mater Misericordiae Ltd HREC
Ethics committee address [1] 311491 0
Aubigny Place, Raymond Tce
South Brisbane, Queensland 4101
Ethics committee country [1] 311491 0
Australia
Date submitted for ethics approval [1] 311491 0
26/09/2022
Approval date [1] 311491 0
16/02/2023
Ethics approval number [1] 311491 0
AM/MML/89297

Summary
Brief summary
In this waitlist-controlled pilot study we want to find out if the application of an innovative new adhesive light patch can reduce pain and improve movement in people with knee osteoarthritis (KOA).

In this study, we will see whether the light device has any benefit compared to no treatment. Although only half of the participants will receive the light treatment, all participants will be seen at home at pre-determined times by the researchers to assess their progress.

Today, the usual approach to pain relief and improved movement is a combination of pain-relief drugs (analgesics that include opioids that may be addictive or have side effects) and exercise rehabilitation. These strategies can work well, but the new light treatment may result in good outcomes without the side effects of drugs, and may promote greater activity in people who have KOA. Almost 70% of all drug-related health disorders are related to opioid use, so reducing the intake of these medicines by using alternative forms of pain relief is a desirable aim.

We have previously carried out a small feasibility study (Vassão and Laakso, 2022; not registered) to work out the protocol details for this research study. In the feasibility study, we found that patients who were planned for knee replacement surgery due to severe KOA accepted and tolerated the light device, that it was easy for patients to apply at home, and the device provided good pain relief. Based on this previous research, we expect that using a low dose of light therapy daily for two weeks may decrease pain and improve function.

The device we are testing is called CareWear. CareWear is a novel, 3-D printed self-adhesive patch with hundreds of micro-diodes (light emitting diodes are found in many home appliances) that emit specific light frequencies that have been found in other research to reduce inflammation and pain. The CareWear patch is registered in the USA and with the Australian Therapeutic Goods Administration (TGA) for applying light to areas of pain and inflammation.

[Vassão PG, Laakso E-L. ‘Photobiomodulation therapy (PBMT) is feasible and acceptable in preconditioning and post-operative recovery of patients after total knee arthroplasty (TKA): A clinical case series’. OBM Integrative and Complementary Medicine 2022; 7(1) doi:10.21926/obm.icm.2201012.]
Trial website
Trial related presentations / publications
Public notes
Vassão PG, Laakso E-L. ‘Photobiomodulation therapy (PBMT) is feasible and acceptable in preconditioning and post-operative recovery of patients after total knee arthroplasty (TKA): A clinical case series’. OBM Integrative and Complementary Medicine 2022; 7(1) doi:10.21926/obm.icm.2201012.

Contacts
Principal investigator
Name 121286 0
A/Prof Liisa Laakso
Address 121286 0
Mater Research,
Augbigny Place, Raymond Tce
South Brisbane Queensland, 4101
Country 121286 0
Australia
Phone 121286 0
+61 419686134
Fax 121286 0
Email 121286 0
liisa.laakso@mater.uq.edu.au
Contact person for public queries
Name 121287 0
A/Prof Liisa Laakso
Address 121287 0
Mater Research,
Augbigny Place, Raymond Tce
South Brisbane Queensland, 4101
Country 121287 0
Australia
Phone 121287 0
+61 419686134
Fax 121287 0
Email 121287 0
liisa.laakso@mater.uq.edu.au
Contact person for scientific queries
Name 121288 0
A/Prof Liisa Laakso
Address 121288 0
Mater Research,
Augbigny Place, Raymond Tce
South Brisbane, Queensland, 4101
Country 121288 0
Australia
Phone 121288 0
+61 419686134
Fax 121288 0
Email 121288 0
liisa.laakso@mater.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will continue to be used for the purposes of R&D thus not able to be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.