BackgroundSpinal disc herniation is a frequently occurring degenerative disease of the spine. Many patients undergoing surgery suffer from radicular pain, known as memory pain, beginning from the third post-operative day. This results in the prescription of high-dose opioid medications. In homeopathy, Hypericum perforatum is known as a remedy for unbearable, shooting or jabbing pain especially when neural damage is involved. Reduction of pain after application of H. perforatum has been observed in previous studies. This study is aimed to investigate whether homeopathic H. perforatum in a potentisation of C200 leads to the reduction of post-operative pain and a decrease of pain medication compared to placebo.Methods/designThis is a monocentric, double-blind, randomised placebo-controlled trial conducted at the Department of Neurosurgery at the Community Hospital Herdecke, Germany. One hundred study participants are being recruited from inpatients undergoing elective, monosegmental, lumbar microdiscectomy surgery. Patients are randomly allocated to receive homeopathic treatment or placebo in addition to usual pain management after surgery. The primary clinical outcome is pain reduction after 3 days of inpatient care as measured by pain reduction of subjective pain on a 100-mm Visual Analogue Scale (VAS) at the third post-operative day. Statistical analysis will be carried out by means of a covariance model with adjustment for baseline values and patient expectation for all randomised patients.DiscussionThis study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic H. perforatum after monosegmental spinal microdiscectomy. We intend to clarify the potential of homoeopathic H. perforatum to reduce surgery-associated pain.Trial registrationGerman Clinical Trials Register, ID: DRKS00007913. Registered on 17 October 2014.EudraCT – Nr: 2013–001383-31.Data sets from the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) are updated every 4 weeks automatically to the International Clinical Trials Registry Platform of World Health Organisation: http://apps.who.int/trialsearch/.ResponsibilitiesSponsor:Witten/Herdecke UniversityAlfred-Herrhausen-Straße 5058,448 WittenDeputy of the sponsor:Dr. Wolfgang Eglmeier (Head of Centre for Clinical Trials Witten/Herdecke)Alfred-Herrhausen-Straße 5058,448 WittenE-mail: wolfgang.eglmeier@uni-wh.dePrincipal investigator:Prof. Dr. med. Wolfram ScharbrodtCommunity Hospital HerdeckeDepartment for NeurosurgeryGerhard-Kienle-Weg 458,313 Herdeckew.scharbrodt@gemeinschaftskrankenhaus.deProject coordination:Christa RaakFaculty for Health (Department for Integrative and Anthroposophic Medicine)University Witten/Herdecke gGmbhGerhard-Kienle-Weg 458,313 Herdeckechrista.raak@uni-wh.deProject manager/data analysis/biometry:Prof. Dr. Thomas OstermannFaculty for Health (Department for Psychology and Psychotherapy)University Witten/Herdecke gGmbhAlfred-Herrhausen-Straße 5058,448 Wittenthomas.ostermann@uni-wh.de
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