Auriculotherapy for Osteoarthritis Knee
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
The OA condition will be assessed by physical examination based on the clinical criteria of the American College of Rheumatology criteria. The clinical criteria consisted of pain in the knee and any three of the following:
- aged 50 years of age or over;
- <=30 minutes of morning stiffness;
- crepitus on active joint motion;
- bony tenderness;
- bony enlargement; or
- no palpable joint warmth.
This classification has been reported to yield 84% specificity and 89% sensitivity for diagnosis of OA knee.
Exclusion Criteria:
- other connective tissue diseases affecting the knee;
- knee joint steroid injections within the preceding three months;
- having a hearing aid or pacemaker in situ (this is to avoid possible interaction between the pacemaker and the magnetic pellets);
- receiving AT within the preceding three months;
- suffering from aural injuries or infections; and
- inability to understand instructions or give consent.
The assessment is conducted by a research assistant who will receive intensive coaching on the physical assessment and therapy administration by the research team. Potential subjects will be further assessed by a registered medical practitioner who has over 15 years of clinical experience when the assessment on the OA condition by the RA and the research team is in doubt.
Sites / Locations
- Sai Kung District Community Centre
- The Neighbourhood Advice-Action Council
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Placebo Comparator
Treatment arm 1
Treatment arm 2
Treatment arm 3
Placebo arm
Subjects will receive magnetotherapy (MAT). The magnetic pellets will contain an average of ~200 gauss/pellet magnetic flux densities, with a diameter of 1.76 mm. The experimental object will be applied to the reactive region of each of the six selected acupoints as detected by an acupoint detector. The justifications for selecting these acupoints are described below. To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" prior to the application of MAT. Subjects will be asked to wear a pair of laser protective goggles to "blind" them during therapy administration.
Subjects will receive laser auriculotherapy (LAT). A laser device (pointer pulse) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz, which is a common acceptable dosage for clinical use12, 26. This application belongs to a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the reactive region of each of the six selected acupoints on the ear. Laser protective goggles will be provided to the subjects and the researchers for eye protection. Similarly, a plaster without magnetic pellets that mimics MAT treatment will be applied on these six acupoints after LAT.
Subjects will receive a combined approach using MAT and LAT. LAT will be administered prior to the application of MAT on the selected auricular points, which would be implemented similar to the procedures in treatment arm 1 and 2.
Subjects will serve as a placebo control, and will receive LAT at "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of plaster without magnetic pellets that mimic MAT treatment.