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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Christa Raak, Wolfram Scharbrodt, Bettina Berger, Arndt Büssing, René Geißen, Thomas Ostermann
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2631-6) contains supplementary material, which is available to authorized users.

Abstract

Background

Spinal 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/design

This 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.

Discussion

This 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 registration

German 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/​.
Responsibilities
Sponsor:
Witten/Herdecke University
Alfred-Herrhausen-Straße 50
58,448 Witten
Deputy of the sponsor:
Dr. Wolfgang Eglmeier (Head of Centre for Clinical Trials Witten/Herdecke)
Alfred-Herrhausen-Straße 50
58,448 Witten
E-mail: wolfgang.eglmeier@uni-wh.de
Principal investigator:
Prof. Dr. med. Wolfram Scharbrodt
Community Hospital Herdecke
Department for Neurosurgery
Gerhard-Kienle-Weg 4
58,313 Herdecke
w.scharbrodt@gemeinschaftskrankenhaus.de
Project coordination:
Christa Raak
Faculty for Health (Department for Integrative and Anthroposophic Medicine)
University Witten/Herdecke gGmbh
Gerhard-Kienle-Weg 4
58,313 Herdecke
christa.raak@uni-wh.de
Project manager/data analysis/biometry:
Prof. Dr. Thomas Ostermann
Faculty for Health (Department for Psychology and Psychotherapy)
University Witten/Herdecke gGmbh
Alfred-Herrhausen-Straße 50
58,448 Witten
thomas.ostermann@uni-wh.de
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