The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. However there is no class 1 evidence for this on back pain. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at two weeks, the efficacy or otherwise can be established. Low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.
Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
RECRUITINGPain-related disability, indexed by the Oswestry Disability Index (ODI)
Time frame: Change from baseline ODI score at 2 weeks
Subjective pain, indexed by Visual analogue pain scale
Time frame: Change from baseline visual analogue score over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary
Medication intake
Time frame: Change from baseline medication intake rate over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary
Pain related disability, indexed by the Roland Morris Instrument
Time frame: Change from baseline Roland Morris Instrument scores at 2 weeks
Quality of life, indexed by the EQ-5D-5L questionnaire
Time frame: Change from baseline EQ-5D-5L scores at 2 weeks
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