Clinical Trial Results:
A Randomised Prospective Pilot Study Comparing the Outcomes of Patients with Lumbar Nerve Root Pain Secondary to Lumbar Disc Prolapse Treated by Nerve Root Block with or without the Addition of Clonidine.
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Summary
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EudraCT number |
2010-023262-46 |
Trial protocol |
GB |
Global end of trial date |
19 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Sep 2019
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First version publication date |
21 Sep 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
20101005PH
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
RD+E Hospital NHSFT
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Sponsor organisation address |
Barrack Road, Exeter, United Kingdom, EX2 5DW
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Public contact |
Miss J Lowe, R+D Department, 0044 1392406933, joanne.lowe3@nhs.net
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Scientific contact |
Miss J Lowe, R+D Department, 0044 1392406933, joanne.lowe3@nhs.net
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Feb 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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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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Protection of trial subjects |
There is the potential for patients who are given clonidine to experience a potentially severe drop in blood pressure. We have taken the advice of a consultant in anaesthetics about this. She has recommended that all study participants should have an intra-venous cannula inserted so that appropriate medication can be adminstered quickly in the event of a sudden blood pressure drop. She has also recommended that blood pressure is monitored at 10 minute intervals for the first hour and 15 minute intervals for the second hour after administration of the injection.Patients are to be kept in hospital for 4 hours post-injection. Any blood pressure change will have come to light by then.
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Background therapy |
nil | ||
Evidence for comparator |
Lumbar nerve root pain secondary to disc prolapse is common. 90% of patients will have a good or excellent outcome at 1 year without undergoing surgical management. For many patients, the nerve root pain is so severe that waiting for natural resolution is unacceptable. Surgery to remove the piece of disc pressing on the nerve is one treatment option. Not all patients who undergo surgical care are satisfied with up to 20% of patients dissatisfied with the result. Lumbar nerve root blocks are a common procedure used in these cases to try and provide short term symptomatic relief and to allow the patients to function more normally whilst awaiting the potential for natural resolution of the complaint. Success rate of such injections varies. Studies have shown that between 53 and 60% of people who were listed to have surgery, did not need to proceed as the injection significantly reduced their pain. There remains however, a need for a more effective, longer term non-surgical procedure as a surgery sparing procedure. | ||
Actual start date of recruitment |
12 Jul 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
100
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
All participants recruited 12/07/11 to 08/08/13 in UK | ||||||||||||
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Pre-assignment
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Screening details |
55 participants screened and excluded: 22 declined study entry, 11 spontaneously resolved, 8 had previous intervention, 7 exceeded age criteria, 5 had cardiac issues, 2 had poor language skills 100 participants met inclusion criteria | ||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
100 | ||||||||||||
Number of subjects completed |
100 | ||||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||
Roles blinded |
Subject | ||||||||||||
Blinding implementation details |
Participants were informed that they would not be told study arm allocation. Anonymised data was sent to an independent statistician for analysis. They were only given a unique study identity number for identification
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Standard treatment arm | ||||||||||||
Arm description |
Patients undergoing lumber nerve root block injection using the standard regimen of 1% lidocaine to the skin as local anaesthetic, with 40 milligrams of kenalog and 3 mls of 0.25% marcain for the injection | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Kenalog and marcain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Epidural use
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Dosage and administration details |
40 milligrams kenalog and 3 mls 0.25% marcain given as transforaminal epidural steroid injection
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Arm title
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Intervention arm | ||||||||||||
Arm description |
The addition of 75 mcg clonidine hypochloride to the standard nerve root block injection | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
clonidine hypochloride
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Investigational medicinal product code |
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Other name |
Catapres
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
75 micrograms given as transforaminal epidural steroid injection - added to the standard nerve root block of 3mls of 0.25% marcain and 40 mg kenalog
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Standard treatment arm
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Reporting group description |
Patients undergoing lumber nerve root block injection using the standard regimen of 1% lidocaine to the skin as local anaesthetic, with 40 milligrams of kenalog and 3 mls of 0.25% marcain for the injection | ||
Reporting group title |
Intervention arm
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Reporting group description |
The addition of 75 mcg clonidine hypochloride to the standard nerve root block injection | ||
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End point title |
Success or failure | |||||||||
End point description |
The procedure was deemed a success if no further intervention (further injection or surgery) was required within 1 year of the injection
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End point type |
Primary
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End point timeframe |
1 year after injection
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Statistical analysis title |
Success or failure: outcome by group | |||||||||
Comparison groups |
Standard treatment arm v Intervention arm
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Median difference (final values) | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From time of injection to 6 weeks post-injection follow-up
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Adverse event reporting additional description |
No adverse events were reported. 4 hour monitoring immediately post injection and direct questioning at 6 week post-injection follow up clinic attendance
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: None reported |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Dec 2011 |
1 amendment occurred to change the name of the Chief Investigator on the study consent form and to outline that members of the regulatory authorities may access trial information for monitoring, audit and safety purposes |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
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