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Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT02160483
Recruitment Status : Withdrawn (This study is not feasible to conduct as functional brain imaging capability is inadequate. CIRB acknowledged in June 2016.)
First Posted : June 10, 2014
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief Summary:
Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.

Condition or disease Intervention/treatment Phase
Pelvis Pain Chronic Endometriosis of Uterus Other: Functional magnetic resonance imaging Not Applicable

Detailed Description:
Multimodal magnetic resonance neuroimaging will be utilised. Arterial spin labelling is tightly coupled with cerebral metabolism and can be used as a marker of neural activity. Resting state magnetic resonance imaging which measures synchronous activity across the brain, allows detection of functional connectivity of intrinsic brain network. Diffusion tensor imaging detects the anisotropic water diffusion in axonal fibres can provide information on connectivity and fibre tracts. Magnetic resonance spectroscopy would enable the levels of neurotransmitter to be elucidated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
Estimated Study Start Date : June 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnetic resonance imaging
Functional magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance spectroscopy to evaluate women with chronic pelvic pain and/ or endometriosis
Other: Functional magnetic resonance imaging
3 Tesla magnetic resonance imaging
Other Name: FMRI




Primary Outcome Measures :
  1. Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging [ Time Frame: 1 hour ]
    Magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance imaging


Secondary Outcome Measures :
  1. Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores [ Time Frame: 1 hour ]
    Anxiety, depression and pain catastrophizing scales used for psychological testing



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic pelvic pain
  • Endometriosis

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160483


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Duke-NUS Graduate Medical School
Investigators
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Principal Investigator: Ban L Sng, FANZCA KK Women's and Children's Hospital
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02160483    
Other Study ID Numbers: 2013/728/D
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by KK Women's and Children's Hospital:
Chronic pelvic pain
Endometriosis
Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Pelvic Pain
Pain
Neurologic Manifestations
Uterine Diseases