Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03325374
Study type Observational
Source University of Edinburgh
Contact
Status Completed
Phase
Start date November 2015
Completion date January 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04310670 - Integrated Treatment in FND (Functional Neurological Disorders) N/A
Not yet recruiting NCT06346873 - Demonstrating Efficacy of JOGO for the Treatment of Tremor N/A
Active, not recruiting NCT05941702 - Body Signal Integration Training: A Case Series N/A
Recruiting NCT06084325 - The Role of Oxytocin and Interoception in Functional Neurological Disorder
Active, not recruiting NCT05581810 - Rehabilitation for Functional Memory Symptoms After Concussion N/A
Recruiting NCT06149728 - Pain Assessment and Transcranial Magnetic Stimulation Tolerability in Patients With a Functional Neurological Disorder
Terminated NCT02764476 - Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder N/A
Not yet recruiting NCT06362161 - Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND
Active, not recruiting NCT03857347 - Psychoeducation Group Intervention for FND N/A
Terminated NCT03731078 - Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
Not yet recruiting NCT05731648 - Role of Functional Neurosurgery in Management of Spasticity
Not yet recruiting NCT06422819 - Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo N/A
Completed NCT05634486 - Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders N/A
Not yet recruiting NCT05723276 - Psilocybin in Functional Neurological Disorder N/A
Recruiting NCT06257069 - Tremor Retrainer Software Application for Functional Tremor N/A
Completed NCT04942600 - Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders N/A
Recruiting NCT06105996 - ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures N/A