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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00012426
Date of registration:	09/05/2017
Prospective Registration:	Yes
Primary sponsor:	DGOM e.V. c/o Consalta
Public title:	Clinical-practical validity of vegetative rhythms in peripheral physiological signals
Scientific title:	Clinical-practical validity of vegetative rhythms in peripheral physiological signals
Date of first enrolment:	01/10/2020
Target sample size:	200
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00012426
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: basic science
Phase:	N/A

Countries of recruitment
Germany	Switzerland

Contacts

Name:	Holger Pelz
Address:	Gothestr. 18 68161 Mannheim Germany
Telephone:	+491712856374
Email:	praxis@dr-holger-pelz.de
Affiliation:	DGOM e.V. c/o Consalta

Name:	Holger Pelz
Address:	Gothestr. 18 68161 Mannheim Germany
Telephone:	+491712856374
Email:	praxis@dr-holger-pelz.de
Affiliation:	DGOM e.V. c/o Consalta

Key inclusion & exclusion criteria

Inclusion criteria: Somatoform, psychosomatic and functional disorders and pain syndromes
Exclusion criteria: Absence of consent, minority, non-working persons, morphine medication, psychotropic medication, basic psychiatric disorders

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

F45
R52.1

Chronic intractable pain

Somatoform disorders

R52.1

Intervention(s)

Group 1: osteopathic treatment: Vault Hold

osteopathic treatment: CV4

respectively at T0, T1, T2 at one week interval

Group 2: SHAM treatment

respectively at T0, T1, T2 at one week interval

Primary Outcome(s)

Pain at T0, T1, T2

Secondary Outcome(s)

SF12, MAIA 2, STAI 5, ICR-ICD10 Symptom Rating,
change of physiological reactions
T0, T1 (week 1), T2 (week 2)

Secondary ID(s)

Source(s) of Monetary Support

Head-Genuit-Stiftung, HGS

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 03/04/2017
Contact:

ethikkommission@aekn.de

Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am Menschen

+49-511-3802208

ethikkommission@aekn.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00012426#studyResults

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