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High versus low dose Nortriptyline for pain control and sleep in the presence of radicular back pain.

High versus low dose Nortriptyline for pain control and sleep in the presence of radicular back pain.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001304820
Enrollment
100
Registered
2012-12-17
Start date
2012-12-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Wellington Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026