E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lumbar nerve root pain secondary to disc prolapse. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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)? |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The avoidance of further secondary care surgical team intervention, i.e. lumbar discectomy surgery or repeat injection |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study will end when the last participant has reached one year since the intervention being studied (i.e. lumbar nerve root block)and has returned the postal questionnaires to us about their outcome. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |