Pilot study to develop a placebo far-infrared (FIR) device
Research type
Research Study
Full title
Assessment of the efficacy of blinding with a placebo far infrared device in arteriovenous fistulae – a randomised, double blind pilot study
IRAS ID
230334
Contact name
Simon R Knight
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Haemodialysis is a treatment for kidney failure, where the blood is filtered through a machine to remove waste products and excess fluid. Blood is removed and returned to the body by placing needles in a fistula or graft that connect via tubes to the dialysis machine. A fistula is a permanent join, created by a surgeon, between a vein and artery, usually in the arm. A graft is an artificial blood vessel used if the patient’s own veins are not suitable to create a fistula.
Fistula and graft problems regularly occur – the can narrow (“stenosis”) or block (“thrombosis”). There is some evidence that an invisible light treatment called Far Infrared Therapy (FIR) might help reduce fistula problems. Experiments in animals and humans suggest that this treatment can slow down the changes that lead to narrowing. Early clinical trials have shown that treatment may reduce the development of stenosis or thrombosis.
We are currently planning a large trial to see if FIR therapy works, to decide if it should be used routinely in dialysis units in the UK. When designing a large trial like this, we often try to “blind” patients to whether they are getting treatment or not. This is done by using a dummy (“placebo”) machine – a machine that looks and acts just the same as the real thing, but does not give any active treatment. We have made a dummy FIR machine, and the purpose of the present study is to see if people can tell the difference between the real machine and the placebo machine. If people cannot tell the difference, we will use the dummy machine in the larger trial that we are planning. We are also using this opportunity to test the questionnaires and measurements that we plan to take during the larger trial.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0427
Date of REC Opinion
12 Sep 2017
REC opinion
Unfavourable Opinion