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Open Access 01-12-2018 | Study protocol

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

Authors: Christa Raak, Wolfram Scharbrodt, Bettina Berger, Arndt Büssing, René Geißen, Thomas Ostermann

Published in: Trials | Issue 1/2018

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

Available only for authorised users

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Title: Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial
Authors: Christa Raak
Wolfram Scharbrodt
Bettina Berger
Arndt Büssing
René Geißen
Thomas Ostermann
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2631-6

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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