Lumbar nerve root pain secondary to disc prolapse.
Conditions
Interventions
Trade Name: catapres.
Product Name: clonidine hydrochloride
Pharmaceutical Form: Solution for injection
Sponsors
Royal Devon & exeter Foundation trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18-65 y.o. complaining of nerve root pain, radiating into one leg, caused by an MRI scan proven lumbar nerve root compression secondary to lumbar disc prolapse at a single level of the lumbar spine. They will not have undergone any previous secondary care intervention (surgery, previous nerve root block) for this current nor a previous complaint. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients refusing informed consent for admission to the study. This will include patients who opt for surgical treatment as their first treatment option. • Patients aged under 18 or over 65 y.o. • Previous secondary care intervention in the lumbar spine (surgery, previous nerve root block) • Nerve root pain caused by infection, fracture, tumour, cauda equina syndrome, spinal stenosis (central, lateral recess or foraminal) • Lumbar disc prolapse causing cauda equina syndrome- a condition which compromises the nerves that control bladder, bowel and sexual function. This is a condition requiring urgent surgical decompression and it would not be ethical to include patients with this condition in this study. • Disc prolapse causing nerve root compression at more than one level of the lumbar spine • Pregnancy • Patients unable to understand the consenting process - Patient allergic to any of the injectates -Patients with known ischaemic heart disease, exertional angina -Patients with known hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with sciatica having MRI proof of disc prolapse, does Clonidine and standard root block compared with standard root block alone (marcaine anaesthetic plus steroid), result in less pain, improved function and quality of life and prevention of further secondary care intervention (repeat injections, surgery and GP visits)?;Secondary Objective: This pilot study is a scaled down version of what is planned to be a full randomised study. As such, it has many important functions, including: 1. It will allow us to assess the ease of recruitment of study participants, and the rate of participant attrition. 2. It will allow us to assess the ease of data capture and collection. 3. It may help refine the participant eligibility criteria, the usefulness of our outcome criteria and to carry out the practical task of data collection. 4. It will allow us to estimate the standard deviation of our outcome measures, and to inform us of the sample size needed for a definitive study. ;Primary end point(s): The avoidance of further secondary care surgical team intervention, i.e. lumbar discectomy surgery or repeat injection | — |
Countries
United Kingdom
Outcome results
None listed