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)
Abstract Background Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and contagious viral lesions that may be refractory to standard dermatologic...
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| Format: | Article |
| Language: | English |
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BMC
2017-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1994-4 |
| _version_ | 1818503989037105152 |
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| author | Cathy Gaillard Laure Allain Hélène Legros Sylvie Brucato Yohann Desgue Christophe Rouillon Laure Peyro-Saint-Paul Anne Dompmartin |
| author_facet | Cathy Gaillard Laure Allain Hélène Legros Sylvie Brucato Yohann Desgue Christophe Rouillon Laure Peyro-Saint-Paul Anne Dompmartin |
| author_sort | Cathy Gaillard |
| collection | DOAJ |
| description | Abstract Background Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and contagious viral lesions that may be refractory to standard dermatologic treatments such as cryotherapy, laser therapy, and keratolytic ointments. Biofield therapies are efficient in various pathologies. Their ability to treat warts has never been demonstrated in a scientific study with a robust methodology. Patients with refractory warts often place their trust in these alternative therapies because of the poor results obtained from traditional medicine. We propose a prospective, randomized, single-blind, assessor-blind trial to evaluate the efficacy of treatment of warts by biofield therapy. Methods/design Subjects with warts on their feet or hands will be randomized into two groups: real biofield therapy versus sham therapy. The diagnosis will be made at the time of inclusion, and follow-up will take place in week 3. Comparison of pictures of the warts at baseline and after 3 weeks will be used as the primary outcome measure. The hypothesis is that the extent of the disappearance of the original wart in the group treated by real biofield therapy will be 70% and that it will be 30% in the group treated by sham therapy. Using 90% power and an alpha risk of 5%, 31 subjects are required in each group for a two-tailed proportion comparison test. Discussion To our knowledge, this is the first study to evaluate the efficacy of biofield therapy on warts. Therefore, the aim of this study is to extend knowledge of biofield therapy to another area of medicine such as dermatology and to propose complementary or alternative practices to improve patient well-being. The main strength of the study is that it is a randomized, single-blind, assessor-blind, placebo-controlled study. Trial registration ClinicalTrials.gov identifier: NCT02773719 . Registered on 22 April 2016. |
| first_indexed | 2024-12-10T21:31:07Z |
| format | Article |
| id | doaj.art-1f17cd510f6d43dfb2fd653184657f18 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T21:31:07Z |
| publishDate | 2017-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1f17cd510f6d43dfb2fd653184657f182022-12-22T01:32:47ZengBMCTrials1745-62152017-06-011811610.1186/s13063-017-1994-4Real 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)Cathy Gaillard0Laure Allain1Hélène Legros2Sylvie Brucato3Yohann Desgue4Christophe Rouillon5Laure Peyro-Saint-Paul6Anne Dompmartin7Délégation à la Recherche Clinique et à l’Innovation, Centre Hospitalier Régional Universitaire (CHU) de CaenCentre de Recherche Clinique, Centre Hospitalier Régional Universitaire (CHU) de CaenCentre de Recherche Clinique, Centre Hospitalier Régional Universitaire (CHU) de CaenCentre de Recherche Clinique, Centre Hospitalier Régional Universitaire (CHU) de CaenBiofield Therapy CenterCentre de Recherche Clinique, Centre Hospitalier Régional Universitaire (CHU) de CaenDélégation à la Recherche Clinique et à l’Innovation, Centre Hospitalier Régional Universitaire (CHU) de CaenService de Dermatologie, Centre Hospitalier Régional Universitaire (CHU) de CaenAbstract Background Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and contagious viral lesions that may be refractory to standard dermatologic treatments such as cryotherapy, laser therapy, and keratolytic ointments. Biofield therapies are efficient in various pathologies. Their ability to treat warts has never been demonstrated in a scientific study with a robust methodology. Patients with refractory warts often place their trust in these alternative therapies because of the poor results obtained from traditional medicine. We propose a prospective, randomized, single-blind, assessor-blind trial to evaluate the efficacy of treatment of warts by biofield therapy. Methods/design Subjects with warts on their feet or hands will be randomized into two groups: real biofield therapy versus sham therapy. The diagnosis will be made at the time of inclusion, and follow-up will take place in week 3. Comparison of pictures of the warts at baseline and after 3 weeks will be used as the primary outcome measure. The hypothesis is that the extent of the disappearance of the original wart in the group treated by real biofield therapy will be 70% and that it will be 30% in the group treated by sham therapy. Using 90% power and an alpha risk of 5%, 31 subjects are required in each group for a two-tailed proportion comparison test. Discussion To our knowledge, this is the first study to evaluate the efficacy of biofield therapy on warts. Therefore, the aim of this study is to extend knowledge of biofield therapy to another area of medicine such as dermatology and to propose complementary or alternative practices to improve patient well-being. The main strength of the study is that it is a randomized, single-blind, assessor-blind, placebo-controlled study. Trial registration ClinicalTrials.gov identifier: NCT02773719 . Registered on 22 April 2016.http://link.springer.com/article/10.1186/s13063-017-1994-4Biofield therapyAlternative medicineWartsPapillomavirus infectionsRandomized controlled trialSingle-blind and assessor-blind method |
| spellingShingle | Cathy Gaillard Laure Allain Hélène Legros Sylvie Brucato Yohann Desgue Christophe Rouillon Laure Peyro-Saint-Paul Anne Dompmartin 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 Biofield therapy Alternative medicine Warts Papillomavirus infections Randomized controlled trial Single-blind and assessor-blind method |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Biofield therapy Alternative medicine Warts Papillomavirus infections Randomized controlled trial Single-blind and assessor-blind method |
| url | http://link.springer.com/article/10.1186/s13063-017-1994-4 |
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