None listed
Conditions
Brief summary
In this study (called a randomised, sham-controlled clinical trial) we want to find out if the application of an innovative new adhesive light patch can reduce pain and improve recovery of movement after knee replacement surgery. In this study, we will compare the effect of the active device with the inactive (sham) device. Half of the participants will receive the active treatment, and half will receive the sham treatment. Today, the usual approach to pain relief and movement recovery after knee replacement surgery is a combination of pain-relief drugs (analgesics) and exercise rehabilitation. They work well, but some people continue to have pain after knee replacement for up to 6 or even 12 months; and they may require continued need for pain medications. We have previously carried out a small feasibility study to work out the protocol details for this new research study. In the feasibility study, we found that patients accepted and tolerated the device, that it was easy for patients to apply at home, and the device provided good pain relief both before and after knee replacement surgery and good recovery of physical movement after the surgery. Based on our previous research, we expect that using a low dose of light therapy daily before knee replacement surgery, and daily after the surgery for one week after surgery, may help people to have less pain in the days following surgery. We also think that further treatment in the second week after surgery will aid recovery of movement and reduce pain in the weeks and months following the operation. 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.
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 and
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. The effectiveness of the light patches will be compared to sham light patches. 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. Whether in the sham (inactive) group or the active intervention group, the light patch treatment period lasts for 3 weeks commencing the week before the participants' scheduled surgery, and for the two weeks following knee replacement surgery. Regardless of which group participants are randomly assigned to, they will continue to be seen for follow-up appointments, and will be asked to complete all tests and questionnaires, as described. Participants will be visited at home one week before scheduled surgery, one day before the surgery, and at one week, two weeks, four weeks, and six weeks after knee replacement surgery; and again at 6 months and 12 months after surgery. Participants will also be seen in hospital on Day 4 after surgery when they would normally be expected to be discharged from hospital. 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 above and below the knee at each treatment; and remove the patches 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. Participants will receive the first treatment one week prior to the scheduled knee replacement surgery and will be instructed on how to apply and care for the device at home (placement, application and removal of the patches) for daily treatments until they are admitted to hospital for surgery. 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. After the surgery, participants will recommence light patch applications every day (for 1 week) commencing on the day immediately following knee replacement surgery unless their doctor advises otherwise. The researchers will continue to see participants whilst they are in hospital, and once discharged home. During the second week after the surgery, participants will apply the light patches 3 more times, after which the treatment phase of the research is complete. In total there will be 17 treatments of 30 minutes each over the course of the study, for each participant. Participants will be seen a total of 9 times over the 12 months of the study with the first appointment lasting approximately 2 hours, and each subsequent appointment lasting less than one hour. Participants will be contacted by telephone between appointments; and adherence to treatment is recorded on the treatment device (from which the unidentifiable 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
Mater Misericordiae Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
Males and females between 60 and 87 years old and fit for surgery Undergoing unilateral total knee replacement surgery for severe osteoarthritis at the Mater Hospital Brisbane or Mater Private Hospital Brisbane
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 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 recovery period Photosensitising agents (drugs) Tumour at the knee or thigh where patches will be applied Skin sensitivity to medical adhesives
Outcome results
None listed