None listed
Conditions
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.]
Interventions
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 an
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
Sponsors
Dr Liisa Laakso
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 87 Years
Healthy volunteers
No
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
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
Outcome results
None listed