Clinical trial NCT02773719: Biofields Therapy on Warts
Official title: Effect of the Intervention of Biofields Therapy on Warts of the Hands and Feet in Adults: a Prospective, Randomized, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wart
Energy Medecine
Magnetism
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditionally, healers are willing to look after, two out of three French citizens have already appealed to them at least once during their lives. Many healers in good faith are exercising their magnetism as a "gift" often inherited from elders. Now, they create interest of doctors who do not hesitate in some cases to ensure their cooperation, to implicitly recognize their mysterious talents. Some serious studies have examined these practices: Several studies have been conducted on the influence of biofield therapies in pain, depression and fatigue in cancer disease. The investigators propose a study of the effect of magnetism on the wart disease whose cure is objectively assessable.

Sixty-two subjects in total would be included, comparing 2 proportions observed: the proportion of healing in the group treated with a "real" biofield therapist (recognized and affiliated to the National Group for Alternative Medicine in France) to the proportion of healing in the group treated with a "fake" biofield therapist (someone assessed as not having capacity to magnetize). The "fake" biofield therapist, placebo, has been trained to replicate gestures during a training validated by an independent recognized biofield therapist.


Eligibility criteria: Patients with common warts on hands or feet for over at least 3 months are eligible for the study. Patients fulfilling one or more of the following criteria will not be included: lack of informed consent prior to randomization, younger than 18 years or under judicial protection, treated with oral corticotherapy for more than 6 months, immunosuppressed or with history of transplant surgery, undergoing chemotherapy or suspected to have carcinomatous warts, or patients with infected warts, injured warts or already treated within 90 days with chemical processing, medical device, surgery or ever treated with biofield therapy.

Subject will be excluded from the study if its warts was treated by other treatment during protocol.

* ulcerated wart
* cancerous wart

Primary outcomes:
measure: disappearance of a common palmar or plantar wart
timeFrame: week 3
Secondary outcomes:
measure: disappearance of each other wart than the original one 3 weeks after the therapy
timeFrame: week 3
measure: Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
timeFrame: week3
measure: Percentage of reduction of each wart will be calculated using mean diameter of each wart at W0 and W3
timeFrame: week 3
measure: Disappearance of warts at 6 weeks
timeFrame: week 6
measure: Level of belief in biofield therapy of the subject
timeFrame: week 6
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
citation: Gaillard C, Allain L, Legros H, Brucato S, Desgue Y, Rouillon C, Peyro-Saint-Paul L, Dompmartin A. Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study). Trials. 2017 Jun 7;18(1):263. doi: 10.1186/s13063-017-1994-4.