Genetic and psychometric role in post-surgical acute pain using ASL/regional cerebral blood (rCBF) flow

ISRCTN	ISRCTN25601281
DOI	https://doi.org/10.1186/ISRCTN25601281
Protocol serial number	6829
Sponsor	King's College Hospital NHS Foundation Trust (UK)
Funder	Pfizer Limited (UK)

Submission date: 27/10/2010
Registration date: 27/10/2010
Last edited: 15/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tara Renton
Scientific

King's College London Dental Institute
Denmark Hill Campus
Bessemer Road
London
SE5 9RS
United Kingdom

Phone	+44 (0)20 3299 2313
Email	tara.renton@kcl.ac.uk

Study information

Primary study design	Observational
Study design	Multicentre non-randomised observational diagnosis and screening study
Secondary study design	Non randomised controlled trial
Scientific title	Genetic and psychometric role in post-surgical acute pain using ASL/regional cerebral blood (rCBF) flow
Study objectives	Key research questions include: to assess if functional magnetic resonance imaging (fMRI) changes correlate with patient's expressed dental pain (Visual Analogue Scale [VAS]); and to identify what genes are associated with human pain expression and behaviour in acute post-surgical pain in man.
Ethics approval(s)	ref: 07/H0808/115
Health condition(s) or problem(s) studied	Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental
Intervention	Surgery is undertaken along with MRI scanning and blood tests and psychometric tests.
Intervention type	Other
Primary outcome measure(s)	Whole brain resting state distribution of Cerebral Blood Flow (rCBF) using continuous labelled ASL with multi-shot fast spin echo (FSE).
Key secondary outcome measure(s)	1. Cognitive Coping Strategizing Inventory (CCSI) index 2. Center for Epidemiologic Studies Depression Scale (CES-D) score 3. Computerised Visual Analogue Scale (VAS) measures of perceived intensity of post-surgical pain 4. DNA chip analysis blood 5. DNA chip analysis tissue 6. Eysenck Personality Questionnaire - revised version (EPQ-R) 'E (Extraversion)' and 'N (Neuroticism or Emotionality)' scores 7. Immunohistochemical analysis of known pain receptors 8. Schedule for Clinical Assessment in Neuropsychiatry (SCAN) score 9. The Symptom Checklist-90 - Revised (SCL-90-R) score 10. Students' Test Anxiety Questionnaire (STAQ) pre- and post-trait anxiety and state anxiety score 11. Surgical outcome (difficulty score [1 - 4 scale], depth of impaction, surgery time)
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	45
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2007
Date of final enrolment	19/11/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London Dental Institute

London
SE5 9RS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/02/2011		Yes	No

Editorial Notes

15/05/2017: Publication reference added. In addition, the recruitment end date has been updated from 01/03/2012 to 19/11/2008