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BLB Study Back or Leg Pain and Bladder Symptoms Study (BLB)

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ClinicalTrials.gov Identifier: NCT03325374
Recruitment Status : Active, not recruiting
First Posted : October 30, 2017
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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.


Condition or disease Intervention/treatment
Cauda Equina Syndrome Functional Neurological Disorder Other: Questionnaires and examination

Detailed Description:

Uro-neurological disorders are those in which there is a disturbance of bladder function related to a neurological cause. However, many patients with Uro-Neurological disorders are not found to have explanatory abnormalities despite adequate clinical and radiological investigation, so-called 'scan negative' patients. The BLB study will investigate this problem through an acute disorder, Cauda Equina Syndrome (CES), to provide a better understanding of scan-negative Uro-Neurological disorders.

CES is a devastating condition caused by compression of the cauda equina nerve roots resulting in bowel, bladder and sexual dysfunction with potential lower limb weakness. CES requires urgent surgery and has serious potential morbidity and medico-legal consequences1. Suspected acute CES has a minimum incidence of 11 per 100,000 making it twice as common as multiple sclerosis. However, in the two largest studies both retrospective and from Edinburgh, 43-48% of patients with clinical CES were 'scan-negative' and indeed received no other diagnosis 1,2.

Little is known about patients with 'scan negative' CES and nothing is known about their outcome. Our two studies in Edinburgh found basic clinical and demographic characteristics could not distinguish 'scan positive' and 'scan negative' groups 1,2. However, on the basis of clinical experience, and now prospective pilot data, the investigators hypothesise that many of these patients have either an acute functional disorder or, in some cases, sacral nerve damage not seen on imaging but detectable on anal sphincter EMG. Functional disorders, also called psychogenic/non-organic disorders, refer to genuinely experienced physical symptoms which can be positively identified as not related to underlying neurological disease3. Finding out about the diagnosis of patients with 'scan negative' CES would enable them to access treatment and improve their outcome as well as creating better service provision for them in the long term. There is also limited data on long term outcome in patients with 'scan positive' CES and a wish for knowledge from the medical community about what the priorities for patients with 'scan positive' CES are after discharge. The investigators have called the study subsection 'Back or Leg pain with Bladder symptoms' (BLB) study because this most accurately describes the symptoms patients have and we know that describing something negatively to patients (e.g. medically unexplained symptoms)is found by patients to be unhelpful.

The BLB study asks three main questions; do patients with 'scan negative' CES have symptoms of bowel, bladder, sexual dysfunction and lower limb weakness and sensory abnormalities due to a functional disorder?; do a proportion of patients with 'scan negative' CES have missed neurological disease?; what are the outcomes of patients with 'scan negative' and 'scan positive' CES after three months?


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: BLB Study Back or Leg Pain and Bladder Symptoms Study
Study Start Date : November 2015
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
BLB patients
Patients admitted for urgent MRI with possible cauda equina syndrome will be consented for questionnaires and examination.
Other: Questionnaires and examination
Patients with in the BLB patients study will have interview and questionnaire carried out.




Primary Outcome Measures :
  1. What proportion of patients with 'scan negative' CES have a functional disorder by clinical consensus. [ Time Frame: Nov 15-Aug 18 ]
    Percent of patients with 'scan negative' CES and a functional disorder.


Secondary Outcome Measures :
  1. Demographics (age, gender, work status) in patients with 'scan positive' and 'scan negative' CES. [ Time Frame: Nov 15-Aug 18 ]
    Demographics

  2. Neurological examination findings, using Medical Research Council (MRC) grading and standardised sensory and reflex examinations in patients with 'scan positive' and 'scan negative' CES. [ Time Frame: Nov 15-Aug 18 ]
    MRC grading of strength (0-5, from no power to full power)

  3. 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. [ Time Frame: Nov 15-Aug 18 ]
    Hospital Anxiety and Depression (HADs) scores (<8 negative, 8-10 mild, 8-14 moderate, 15-21 severe).

  4. 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. [ Time Frame: Nov 15-Aug 18 ]
    visual analogue scale from 1 would most value help with to 8 would least value help required

  5. The number of patients with 'scan negative' CES have other neurological disease causing their symptoms. [ Time Frame: Nov 15-Aug 18 ]
    Number of patients who have a neurological diagnosis explaining their symptoms at up to one year after discharged with CES symptoms.

  6. The number of patients with 'scan negative' CES who have sacral nerve dysfunction found on EMG. [ Time Frame: Nov 15-Aug 18 ]
    with 'scan negative' CES who have sacral nerve dysfunction found on EMG.

  7. Bladder function using Urinary Symptom Profile (USP) in patients with 'scan positive' and 'scan negative' CES at symptom onset and at three months after discharge. [ Time Frame: Nov 15-Aug 18 ]
    Urinary Symptom Profile splits symptoms up into stress incontinence(0 none to 9 severe), overactive bladder (0 none to 21 severe), low stream (0 none to nine severe)

  8. Bowel function using The Neurogenic Bowel Dysfunction score in patients with 'scan positive' and 'scan negative' CES at symptom onset and at three months after discharge. [ Time Frame: Nov 15-Aug 18 ]
    10-13 is moderate dysfunction, 14 or over is severe dysfunction

  9. Sexual function using the Arizona Sexual Experiences Questionnaire in patients with 'scan positive' and 'scan negative' CES at symptom onset and at three months after discharge. [ Time Frame: Nov 15-Aug 18 ]
    Abnormal is >19 or 5 or more on any item or 4 or more on three items


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
161 participants admitted to the Western General Hospital, Edinburgh with possible CES.
Criteria

Inclusion Criteria:

  1. Ability to give informed consent
  2. Able to complete online or paper questionnaire.
  3. 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.

Exclusion Criteria:

  1. Age less than 16
  2. Inability to communicate (e.g. do not speak English)
  3. Inability to complete written or oral surveys or give informed consent
  4. 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.

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): NCT03325374


Locations
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United Kingdom
Department of Neurosciences, Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Ingrid Hoeritzauer University of Edinburgh

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03325374     History of Changes
Other Study ID Numbers: 15/NS/0112
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Nervous System Diseases
Conversion Disorder
Cauda Equina Syndrome
Somatoform Disorders
Mental Disorders
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyradiculoneuropathy
Polyneuropathies