Cauda Equina SyndromeBLBNCT03325374
BLB Study Back or Leg Pain and Bladder Symptoms Study
An observational study of Cauda Equina Syndrome and Functional Neurological Disorder, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Cauda Equina Syndrome, Functional Neurological Disorder
- What is being tested?
- Questionnaires and examination
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Jan 2020
- Phase
- Observational
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 161 participants admitted to the Western General Hospital, Edinburgh with possible CES.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Neurosciences, Western General Hospital
Edinburgh, EH4 2XU
About this study
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.
Read the 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?
- Being tested
- Questionnaires and examination
- Medical subject headings
- Cauda Equina Syndrome, Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and examinationOther
Patients with in the BLB patients study will have interview and questionnaire carried out.
| Study group | Role | What they receive |
|---|---|---|
| BLB patients | Patients admitted for urgent MRI with possible cauda equina syndrome will be consented for questionnaires and examination. Receives: Other: Questionnaires and examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Nov 15-Aug 18
Secondary outcomes (9)
Demographics (age, gender, work status) in patients with 'scan positive' and 'scan negative' CES.
Demographics
Measured: 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.
MRC grading of strength (0-5, from no power to full power)
Measured: 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.
Hospital Anxiety and Depression (HADs) scores (<8 negative, 8-10 mild, 8-14 moderate, 15-21 severe).
Measured: 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.
visual analogue scale from 1 would most value help with to 8 would least value help required
Measured: Nov 15-Aug 18
The number of patients with 'scan negative' CES have other neurological disease causing their symptoms.
Number of patients who have a neurological diagnosis explaining their symptoms at up to one year after discharged with CES symptoms.
Measured: Nov 15-Aug 18
The number of patients with 'scan negative' CES who have sacral nerve dysfunction found on EMG.
with 'scan negative' CES who have sacral nerve dysfunction found on EMG.
Measured: Nov 15-Aug 18
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.
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)
Measured: Nov 15-Aug 18
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.
10-13 is moderate dysfunction, 14 or over is severe dysfunction
Measured: Nov 15-Aug 18
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.
Abnormal is >19 or 5 or more on any item or 4 or more on three items
Measured: Nov 15-Aug 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startNov 2015
- Primary completionMay 2018
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cauda Equina SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Ingrid Hoeritzauer, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325374
- Sponsor's protocol ID
- 15/NS/0112
- Acronym
- BLB
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLB Study Back or Leg Pain and Bladder Symptoms Study
- ClinicalTrials.gov ID
- NCT03325374
- Acronym / sponsor ID
- BLB / 15/NS/0112
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Nov 2015
- Primary completion
- May 2018 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 30 Oct 2017 (actual)
- 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.
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.
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?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLB patients | – | Other: Questionnaires and examinationPatients admitted for urgent MRI with possible cauda equina syndrome will be consented for questionnaires and examination. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 161 participants admitted to the Western General Hospital, Edinburgh with possible CES.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Questionnaires and examinationPatients with in the BLB patients study will have interview and questionnaire carried out. | Other | BLB patients |
Primary outcome
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.
9 secondary outcomes
Demographics (age, gender, work status) in patients with 'scan positive' and 'scan negative' CES.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Nov 15-Aug 18
The number of patients with 'scan negative' CES have other neurological disease causing their symptoms.
Time frame: Nov 15-Aug 18
The number of patients with 'scan negative' CES who have sacral nerve dysfunction found on EMG.
Time frame: Nov 15-Aug 18
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Cauda Equina Syndrome
Active, not recruiting
Brief ES for Recovery of Autonomic Function in CES
Cauda Equina Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Ingrid Hoeritzauer principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cauda Equina Syndrome and Functional Neurological Disorder, run by University of Edinburgh at 1 site in United Kingdom.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
What proportion of patients with 'scan negative' CES have a functional disorder by clinical consensus. (time frame: Nov 15-Aug 18). 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 7 Apr 2020; AzTrials last refreshed its copy on 26 Oct 2026.