NCT01766973

Brief Summary

Recent evidence suggests that chronic pain is associated with abnormal connectivity between brain regions associated with the processing of pain. We aim to test the diagnostic power of resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic back pain. Using new methods of image acquisition and analysis we aim to develop a computational method to correctly classify patients and matched control subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 6, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

January 10, 2013

Last Update Submit

June 6, 2018

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (1)

  • Functional brain connectivity

    Assessed by fMRI

    6 months

Study Arms (2)

Chronic back pain

Adults, \>6months duration

Control

Age and sex matched controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with \>6 months of mechanical lower back pain, not sue to any major systemic disease

You may qualify if:

  • age 18-60
  • pain \> 6months
  • right-handed
  • non-smoking
  • mechanical back pain

You may not qualify if:

  • significant neurological or psychiatric disease
  • major systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Study Officials

  • Ben Seymour, MRCP PhD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wellcome Intermediate Clinical Fellow

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 11, 2013

Study Start

April 6, 2013

Primary Completion

April 6, 2016

Study Completion

June 6, 2018

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations

GB(1)