ActiPatch Therapy for Back Pain, Version 1.0
Research type
Research Study
Full title
A randomized controlled trial to assess the benefits of ActiPatch-Pulsed shortwave Therapy for Chronic Lower Back Pain
IRAS ID
178219
Contact name
Tipu Aziz
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
ActiPatch Therapy is medical device that has been developed to treat pain and soft tissue injury. It is CE marked as a class II device, meaning that it has been cleared for sale in the European Union off the shelf, and it is commercially available in the UK. ActiPatch Therapy is simple to use and has no known side effects. The device consists of a control module and a loop antenna and is powered by a battery.
To date there have been no studies showing how well this device works for chronic back pain, chronic pain being pain that has been present for 3 months or longer. Therefore for this clinical trial we are looking to enroll people who have chronic back pain. This clinical trial is a designed as a randomised controlled crossover trial. This means that participants will be randomly given an ActiPatch device that is either active (fully functioning) or a placebo device. Placebo means that it looks identical but does not deliver any treatment. As a crossover trial, participants will receive one (active or placebo) device first for two weeks, followed by a week of no treatment, then another two weeks on the opposite device. Neither participants nor the investigators will be aware of what order the active and placebo devices will be used in.
Participants will be asked to report their levels of pain regularly throughout the trial using standardised pain and disability measuring systems. These reports will be used to assess whether or not the ActiPatch is effective at reducing chronic back pain.
REC name
London - South East Research Ethics Committee
REC reference
15/LO/0926
Date of REC Opinion
20 May 2015
REC opinion
Favourable Opinion