Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial
Introduction Migraine is a leading cause of disability and suffering worldwide. However, conventional pharmacological migraine preventive therapies are often challenging and accompanied by adverse effects. Recently, structured odour exposure has shown to successfully increase pain thresholds in pati...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e071443.full |
| _version_ | 1797746047984861184 |
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| author | Hannes Wahl Vanda Faria Jana Dulheuer Akshita Joshi Anna Klimova Antje Haehner Gudrun Gossrau |
| author_facet | Hannes Wahl Vanda Faria Jana Dulheuer Akshita Joshi Anna Klimova Antje Haehner Gudrun Gossrau |
| author_sort | Hannes Wahl |
| collection | DOAJ |
| description | Introduction Migraine is a leading cause of disability and suffering worldwide. However, conventional pharmacological migraine preventive therapies are often challenging and accompanied by adverse effects. Recently, structured odour exposure has shown to successfully increase pain thresholds in patients with chronic back pain. Despite the importance of the olfactory system in migraine, there are no studies investigating the impact of structured odour exposure in patients with migraine.Methods and analysis This double-blind randomised placebo-controlled trial will be conducted at the Headache Clinic of the University Pain Center at TU Dresden, Germany and aims at investigating the impact of a 12-week structured exposure to odours in women with migraine. Fifty-four women between 18 and 55 years with migraine with aura will be recruited and randomised to training with odours and odourless training. The primary outcomes are mechanical and electrical pain thresholds. Secondary outcomes comprise olfactory threshold and the number of headache days. Other exploratory measurements are headache associated pain intensity, acute analgesic intake, symptoms of anxiety and depression, and quality of life. Additionally, this protocol assesses neuroanatomical and neurofunctional changes associated with the 12-week olfactory training. Data analysis will be executed on the basis of the general linear model considering repeated measurements.Ethics and dissemination Ethical approvals were obtained from the Ethics Board of the TU Dresden (Protocol No. BO-EK-353082020). Participation will only be possible after written informed consent is provided. Findings will be disseminated through peer-reviewed journals and scientific conferences.Trial registration number DRKS00027399. |
| first_indexed | 2024-03-12T15:31:34Z |
| format | Article |
| id | doaj.art-828630144504435e90a51eaadcc0017b |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:31:34Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-828630144504435e90a51eaadcc0017b2023-08-10T03:40:08ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2022-071443Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trialHannes Wahl0Vanda Faria1Jana Dulheuer2Akshita Joshi3Anna Klimova4Antje Haehner5Gudrun Gossrau6Intitute of Neuroradiology, TU Dresden Faculty of Medicine Carl Gustav Carus, Dresden, GermanyDepartment of Otorhinolaryngology, TU Dresden Faculty of Medicine Carl Gustav Carus, Dresden, GermanyDepartment of Otorhinolaryngology, TU Dresden Faculty of Medicine Carl Gustav Carus, Dresden, GermanyDepartment of Otorhinolaryngology, TU Dresden Faculty of Medicine Carl Gustav Carus, Dresden, GermanyNCT Partner Site Dresden, Institute for Medical Informatics and Biometrics, TU Dresden Faculty of Medicine Carl Gustav Carus, Dresden, GermanyDepartment of Otorhinolaryngology, TU Dresden Faculty of Medicine Carl Gustav Carus, Dresden, GermanyInterdisciplinary Pain Center, University Hospital, and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, GermanyIntroduction Migraine is a leading cause of disability and suffering worldwide. However, conventional pharmacological migraine preventive therapies are often challenging and accompanied by adverse effects. Recently, structured odour exposure has shown to successfully increase pain thresholds in patients with chronic back pain. Despite the importance of the olfactory system in migraine, there are no studies investigating the impact of structured odour exposure in patients with migraine.Methods and analysis This double-blind randomised placebo-controlled trial will be conducted at the Headache Clinic of the University Pain Center at TU Dresden, Germany and aims at investigating the impact of a 12-week structured exposure to odours in women with migraine. Fifty-four women between 18 and 55 years with migraine with aura will be recruited and randomised to training with odours and odourless training. The primary outcomes are mechanical and electrical pain thresholds. Secondary outcomes comprise olfactory threshold and the number of headache days. Other exploratory measurements are headache associated pain intensity, acute analgesic intake, symptoms of anxiety and depression, and quality of life. Additionally, this protocol assesses neuroanatomical and neurofunctional changes associated with the 12-week olfactory training. Data analysis will be executed on the basis of the general linear model considering repeated measurements.Ethics and dissemination Ethical approvals were obtained from the Ethics Board of the TU Dresden (Protocol No. BO-EK-353082020). Participation will only be possible after written informed consent is provided. Findings will be disseminated through peer-reviewed journals and scientific conferences.Trial registration number DRKS00027399.https://bmjopen.bmj.com/content/13/7/e071443.full |
| spellingShingle | Hannes Wahl Vanda Faria Jana Dulheuer Akshita Joshi Anna Klimova Antje Haehner Gudrun Gossrau Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial BMJ Open |
| title | Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial |
| title_full | Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial |
| title_fullStr | Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial |
| title_full_unstemmed | Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial |
| title_short | Impact of a 12-week olfactory training programme in women with migraine with aura: protocol for a double-blind, randomised, placebo-controlled trial |
| title_sort | impact of a 12 week olfactory training programme in women with migraine with aura protocol for a double blind randomised placebo controlled trial |
| url | https://bmjopen.bmj.com/content/13/7/e071443.full |
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