BLB Study Back or Leg Pain and Bladder Symptoms Study
Condition: Cauda Equina Syndrome; Functional Neurological Disorder
MeSH terms: Nervous System Diseases; Cauda Equina Syndrome; Conversion Disorder; Hysteria
Study type: Observational

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.
    

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?
    

Intervention name(s): Questionnaires and examination
Intervention type(s): Other
Intervention description(s): Patients with in the BLB patients study will have interview and questionnaire carried out.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        161 participants admitted to the Western General Hospital, Edinburgh with possible CES.
      
Biospecimen description: 
      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.