How to apply blinding to patients and subjects during the the acupuncture clinical trials?
There are "sham acupuncture needles" developed and I think you can google the term to find a suitable device. More important is to also blind the person providing the treatment to avoid bias introduced by verbal and non-verbal communication and behaviour.
I haven't been needled, so be aware that I'm not sure exactly what being needled feels like... so I looked it up.
http://acutakehealth.com/what-does-acupuncture-feel-like
Acupuncture can feel like pressure or warmth or an electric tingle. Perhaps you could get an acupuncture needle and gently place it against the patient's skin while they are being 'needled'. This could help with people who have never been needled before, but I feel someone who has had acupuncture in the past will know the difference. If you plan on using multiple needles at multiple sites (as most acupuncturists do!) then this will not work.
This would be easier if you were doing needling with the patient face-down so that they cannot see what it is that you are doing.
I do not envy you trying to create blinding in this sort of study. It may be that there is not anything comparable that you can do, except have the control patient lie still for a similar amount of time as the needled patient, to at least simulate the experience of quiet and care.
I read a paper that used untrained acupuncturists as the control arm. It sought to compare strategic vs random placement of the needles.
You can download and read this article: http://cdn.intechopen.com/pdfs-wm/43391.pdf. It would be better to combine a sham needle with a sham point.
http://cdn.intechopen.com/pdfs-wm/43391.pdf
This is a tough situation to blind. Consider needle placement near, but not in, the zone of efficacy for the disorder you are trying to treat. Other aspects of study design become very important in these kind of trials: randomization of the subject to group, blinding of the individual(s) who assess treatment effect(s) and (if possible) a primary endpoint that is not subject to observer bias - such as blood pressure, weight loss, serum lipid levels.
Look for sham acupuncture needles, such as the Streitberger, or Park sham needle or contact Takakura in Japan (look up Takakura and Yajima).
To use sham acupuncture points is not a suitable placebo as they are physiologically NOT inert. The sham needles are currently the best 'sham' acupuncture option.
- Badges
- Science topic
- Similar topics
- Correction