Pelvis Pain ChronicNCT02160483
Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
A study testing Functional magnetic resonance imaging in people with Pelvis Pain Chronic and Endometriosis of Uterus, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Pelvis Pain Chronic, Endometriosis of Uterus
- What is being tested?
- Functional magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pelvic pain
- Endometriosis
Who cannot join
- Contraindication to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.
Read the 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.
- Conditions
- Pelvis Pain Chronic, Endometriosis of Uterus
- Being tested
- Functional magnetic resonance imaging
- Keywords
- Chronic pelvic pain, Endometriosis
- Medical subject headings
- Adenomyosis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imagingOther
Also called FMRI
3 Tesla magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging | Experimental | 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 Receives: Other: Functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Secondary outcomes (1)
Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores
Anxiety, depression and pain catastrophizing scales used for psychological testing
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2015 (estimated)
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: This study is not feasible to conduct as functional brain imaging capability is inadequate. CIRB acknowledged in June 2016.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvis Pain ChronicStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban L Sng, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160483
- Sponsor's protocol ID
- 2013/728/D
- Status last verified
- Aug 2026
- First submitted
- 25 May 2014
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Brain Imaging and Psychological Testing in Women With Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT02160483
- Acronym / sponsor ID
- 2013/728/D
- Conditions
- Pelvis Pain Chronic, Endometriosis of Uterus
- Keywords
- Chronic pelvic pain, Endometriosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is not feasible to conduct as functional brain imaging capability is inadequate. CIRB acknowledged in June 2016.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- Jun 2015 (estimated)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging | Experimental | Other: Functional magnetic resonance imagingFunctional 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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic pelvic pain
- Endometriosis
Key exclusion criteria (1 listed)
- Contraindication to magnetic resonance imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imagingAlso: FMRI3 Tesla magnetic resonance imaging | Other | Magnetic resonance imaging |
Primary outcome
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
1 secondary outcome
Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban L Sng, FANZCA principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging in people with Pelvis Pain Chronic and Endometriosis of Uterus, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.