ANZCTR - Registration

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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

Change in numeric pain rating scale (NPRS)

Timepoint [1]

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]

30 second Timed Stands (chair stand) test to assess physical function, dynamic balance and pain

Timepoint [1]

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]

40m fast-paced walk test to assess pain, walking speed over a short distance, and changing direction whilst walking

Timepoint [2]

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]

Timed Up-and-Go test to assess functional mobility, balance and pain

Timepoint [3]

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]

Western Ontario and McMaster Universities Arthritis Index (WOMAC) knee score to assess pain, stiffness and physical function

Timepoint [4]

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]

Hospital anxiety and depression scale (HADS)

Timepoint [5]

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]

European Quality of Life Five Dimension questionnaire (EQ-5D-5L)

Timepoint [6]

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]

International Physical Activity Questionnaire (IPAQ)

Timepoint [7]

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]

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]

- 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]

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [9]

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]

Knee joint range of motion (flexion and passive/active extension) using standard goniometer

Timepoint [10]

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]

Quadriceps muscle strength using manual muscle testing

Timepoint [11]

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]

Consumption of analgesic medications (by study diary)

Timepoint [12]

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]

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]

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

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]

Charities/Societies/Foundations

Name [1]

Mater Foundation

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Liisa Laakso

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Mater Research

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Misericordiae Ltd HREC

Ethics committee address [1]

Aubigny Place, Raymond Tce
South Brisbane, Queensland 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/09/2022

Approval date [1]

16/02/2023

Ethics approval number [1]

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

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

A/Prof Liisa Laakso

Address

Mater Research,
Augbigny Place, Raymond Tce
South Brisbane Queensland, 4101

Country

Australia

Phone

+61 419686134

Email

[email protected]

Contact person for public queries

Name

Liisa Laakso

Address

Mater Research,
Augbigny Place, Raymond Tce
South Brisbane Queensland, 4101

Country

Australia

Phone

+61 419686134

Email

[email protected]

Contact person for scientific queries

Name

Liisa Laakso

Address

Mater Research,
Augbigny Place, Raymond Tce
South Brisbane, Queensland, 4101

Country

Australia

Phone

+61 419686134

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically