search
Back to results

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

Primary Purpose

Pelvis Pain Chronic, Endometriosis of Uterus

Status
Withdrawn
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Functional magnetic resonance imaging
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pelvis Pain Chronic focused on measuring Chronic pelvic pain, Endometriosis

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic pelvic pain
  • Endometriosis

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic resonance imaging

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging
Magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance imaging

Secondary Outcome Measures

Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores
Anxiety, depression and pain catastrophizing scales used for psychological testing

Full Information

First Posted
May 25, 2014
Last Updated
August 18, 2017
Sponsor
KK Women's and Children's Hospital
Collaborators
Duke-NUS Graduate Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT02160483
Brief Title
Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
Official Title
Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
This study is not feasible to conduct as functional brain imaging capability is inadequate. CIRB acknowledged in June 2016.
Study Start Date
June 2015 (Anticipated)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital
Collaborators
Duke-NUS Graduate Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvis Pain Chronic, Endometriosis of Uterus
Keywords
Chronic pelvic pain, Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic resonance imaging
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Functional magnetic resonance imaging
Other Intervention Name(s)
FMRI
Intervention Description
3 Tesla magnetic resonance imaging
Primary Outcome Measure Information:
Title
Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging
Description
Magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance imaging
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores
Description
Anxiety, depression and pain catastrophizing scales used for psychological testing
Time Frame
1 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic pelvic pain Endometriosis Exclusion Criteria: Contraindication to magnetic resonance imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban L Sng, FANZCA
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs