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Trial registered on ANZCTR


Registration number
ACTRN12612001304820
Ethics application status
Approved
Date submitted
22/10/2012
Date registered
17/12/2012
Date last updated
17/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
High versus low dose Nortriptyline for pain control and sleep in the presence of radicular back pain.
Scientific title
High versus low dose Nortriptyline for pain control and sleep in the presence of radicular back pain.
Secondary ID [1] 281420 0
Nil Known
Secondary ID [2] 281691 0
nil
Universal Trial Number (UTN)
U1111-1136-1941
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiculopathy 287669 0
Condition category
Condition code
Musculoskeletal 288010 288010 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized triple blinded controlled trial, using oral 50mg Nortriptyline once a day for 3 months and assessing for pain and sleep in the presence of radiculopathic leg pain.
Intervention code [1] 285914 0
Treatment: Drugs
Comparator / control treatment
oral 10mg Nortriptyline once a day for 3 months.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288221 0
Pain - VAS
Timepoint [1] 288221 0
0, 2, 6, 12 weeks
Secondary outcome [1] 299633 0
Sleep using MOSSS (medical outcome study sleep scale)
Timepoint [1] 299633 0
0, 2, 6, 12 weeks

Eligibility
Key inclusion criteria
1. leg-dominant pain that is worse below the gluteal fold
2. exam either has positive irritative test or demonstrate newly acquired conduction loss
3. if imaging is performed it should be consistent with a radiculopathy
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. previous depression or psychiatric disorder
2. history of cardiovascular disease
3. prostatic hypertrophy
4. chronic constipation
5. glaucoma
6. elderly (>70yrs)
7. seizure disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All willing patients presenting to the outpatient orthopaedic service, experiencing symptoms consistent with an acute radiculopathy, will be referred on to the coordinating researcher (CR). The CR will confirm the patient is happy to participate then apply the inclusion and exclusion criteria. Using block randomization patients will be allocated into either high or low dose groups. Concealment will be hidden by sealed opaque envelopes. The CR will be the only person aware of the treatment group. After this the patients details will be passed on to a second researcher (SR) who will conduct the telephone questionnaires, he will be unaware of the treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using block randomization patients will be allocated into either high or low dose groups. The randomization will have been set out in a table and will be given in order of presentation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All patients that have met the inclusion and exclusion criteria will have a prescription of either high and low dose Nortriptyline faxed to their pharmacist. Additionally, CR will gather simple demographic detail, such as age, occupation and smoking status. Following enrollment, the SR will be informed so he will be able to conduct the telephone questionnaires at the prescribed intervals.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4617 0
New Zealand
State/province [1] 4617 0
Wellington

Funding & Sponsors
Funding source category [1] 286185 0
Hospital
Name [1] 286185 0
Wellington Hospital
Country [1] 286185 0
New Zealand
Primary sponsor type
Hospital
Name
Wellington Hospital
Address
Riddiford St,
Newtown,
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 284995 0
None
Name [1] 284995 0
Address [1] 284995 0
Country [1] 284995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288257 0
Central Regional Ethics Committee
Ethics committee address [1] 288257 0
Central Regional Ethics Committee
c/- Ministry of Health PO Box 5013 1 the Terrace Wellington
6021
Ethics committee country [1] 288257 0
New Zealand
Date submitted for ethics approval [1] 288257 0
Approval date [1] 288257 0
10/07/2012
Ethics approval number [1] 288257 0
CEN/12/06/033

Summary
Brief summary
Our aim is to evaluate if a higher dose of drug called Nortriptyline improves sleep and pain control in patients suffering from leg pain due to an underlying spinal pathology. The information obtained will improve our management of future patients with your condition.

We are performing this study throughout the Wellington area.

We will assess in clinic in the same manner we would do normally, and initiate the same management we routinely give. However, in addition we will ask some medical questions to ensure it is safe to take the drug and that the back problem is suitable to be included in the study. Then we will randomly allocate to a low or high dose of the drug Nortriptyline. This drug has traditionally been used in a low dose for this back problem but some doctors prescribe higher doses. In these higher doses it is not known if the pain control is improved nor is it known if with this treatment sleep disturbance is minimized. The medication is reasonably safe as long as you do not have a history of: cardiovascular disease, prostatic hypertrophy, chronic constipation, glaucoma or elderly. The medication has the potential, like many other medications, of producing side effects. These include: dry mouth, sedation, constipation, and increased appetite. An occasional side effect is a rapid or irregular heartbeat.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34856 0
Dr Carl Chisholm
Address 34856 0
Wellington Hospital,
Riddiford Street,
Newtown
Wellington
6021
Country 34856 0
New Zealand
Phone 34856 0
02102608629
Fax 34856 0
Email 34856 0
[email protected]
Contact person for public queries
Name 18103 0
Carl Chisholm
Address 18103 0
Wellington Hospital,
Riddiford Street,
Newtown
Wellington
6021
Country 18103 0
New Zealand
Phone 18103 0
+64 02102608629
Fax 18103 0
No fax
Email 18103 0
[email protected]
Contact person for scientific queries
Name 9031 0
Carl Chisholm
Address 9031 0
Wellington Hospital,
Riddiford Street,
Newtown
Wellington
6021
Country 9031 0
New Zealand
Phone 9031 0
+64 02102608629
Fax 9031 0
None
Email 9031 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.