BLB Study Back or Leg Pain and Bladder Symptoms Study

NCT03325374 | Completed

• 1 other identifier: 15/NS/0112
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The research focuses on Cauda Equina Syndrome (CES) which describes damage to the nerves in the lower back which supply bladder, bowels, sexual function and the legs usually from slipped discs in the spine. CES is as common as multiple sclerosis and is diagnosed using an MRI scan of the spine, 'scan positive' CES. However, about 50% of people presenting with the symptoms of CES have MRI scans which do not explain their symptoms, 'scan negative' patients. The BLB study will be the first large clinical study comparing patients with 'scan positive' and 'scan negative' CES. All patients admitted to the Western General Hospital, Edinburgh with possible CES will be invited to participate. The study consists of detailed history taking, examination and a questionnaire following up patient's symptoms at three months. The study aims to see what differences exist between the 'scan positive' and 'scan negative' groups, help doctors understand more about the outcomes of both groups and discover the number of patients with 'scan negative' CES who have functional disorders (previously called medically unexplained or conversion disorders) or undiagnosed neurological disorders.

Conditions

Cauda Equina Syndrome; Functional Neurological Disorder

Outcome Measures

Primary Outcomes (1)

• What proportion of patients with 'scan negative' CES have a functional disorder by clinical consensus.

  Percent of patients with 'scan negative' CES and a functional disorder.

  Nov 15-Aug 18

Secondary Outcomes (9)

• Demographics (age, gender, work status) in patients with 'scan positive' and 'scan negative' CES.

  Nov 15-Aug 18

• Neurological examination findings, using Medical Research Council (MRC) grading and standardised sensory and reflex examinations in patients with 'scan positive' and 'scan negative' CES.

  Nov 15-Aug 18

• Hospital Anxiety and Depression (HADs) scores and Structured clinical interview for DSM (SCID) findings in patients with 'scan positive' and 'scan negative' CES at onset of symptoms and HADs scores three months after symptom onset.

  Nov 15-Aug 18

• Patient priorities after discharge rated using a visual analogue scale. Options will be pain, bladder symptoms, bowel symptoms, sexual function, sensory disturbance, financial, worry/stress/low mood.

  Nov 15-Aug 18

• The number of patients with 'scan negative' CES have other neurological disease causing their symptoms.

  Nov 15-Aug 18

Study Arms (1)

BLB patients

Patients admitted for urgent MRI with possible cauda equina syndrome will be consented for questionnaires and examination.

Other: Questionnaires and examination

Interventions

Questionnaires and examination OTHER

Patients with in the BLB patients study will have interview and questionnaire carried out.

BLB patients

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

161 participants admitted to the Western General Hospital, Edinburgh with possible CES.

You may qualify if:

• Ability to give informed consent
• Able to complete online or paper questionnaire.
• Patients admitted to the regional neurosurgical unit, Western General Hospital, Edinburgh with suspected cauda equina syndrome for an MRI scan. Demographic data from all patients attending any NHS Lothian site who have an MRI scan for suspected CES.

You may not qualify if:

• Age less than 16
• Inability to communicate (e.g. do not speak English)
• Inability to complete written or oral surveys or give informed consent
• Age over 100. The upper age limit is set at 100 to allow the greatest number of participants the opportunity to take part. As the study is a follow up study concerns about mortality and high drop out in this age group led to the upper limit of 100 being set.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Department of Neurosciences, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for genetic storage (DNA) and later study will be requested from all patients. No tests will be done initially. We have an excellent opportunity to better understand the genetics of degenerative disc disease and/or functional disorders using the comparison of DNA between the 'scan positive' and 'scan negative' group.

MeSH Terms

Conditions

Cauda Equina Syndrome; Conversion Disorder

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Ingrid Hoeritzauer

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: October 30, 2017
• Study Start: November 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: January 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)