Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009672
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-02-02
Brief Title:
Pain Treatment for Sciatica
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Morphine Nortriptyline and Their Combination in Sciatica Treatment
Status:
COMPLETED
Status Verified Date:
2006-12-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the effectiveness of two drugs-nortriptyline and MS Contin a type of morphine-to treat pain caused by lumbar radiculopathy or sciatica Sciatica results from damage to the lumbar nerve roots typically causing back pain and sharp shooting pain down one or both legs Although sciatica is common there are no good treatments for it Tricyclic antidepressants such as nortriptyline and opioids such as morphine have been effective in treating other kinds of pain from nerve damage
Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study
Participants will provide a medical history and occupational and other social information They will undergo a neurological examination routine blood tests and an electrocardiogram and will fill out three questionnaires providing information on daily functioning and psychological well-being
This cross-over study consists of several parts including a baseline study and four different treatment regimens During each part patients keep a daily log in which they rate their pain record other procedures they undergo such as injections and manipulations and record medication side effects
In the first week of the study patients remain on their current medications Any antidepressants or opioids are stopped gradually before starting the drug trials After the first week patients go through the following four drug trials in random order
1 Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg to 100 mg and an inert placebo for morphine An inert placebo is a dummy pill it looks like the test drug but has no active ingredient
2 MS Contin morphine and inert placebo-Patients take MS Contin in doses ranging from 30 mg to 90 mg and an inert placebo for nortriptyline
3 Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone
4 Active placebo and inactive placebo-Patients take an active placebo-in this case benztropine-and an inert placebo An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug-in this case slight sleepiness or dry mouth Benztropine is given at one-third the recommended dosage
For each drug regimen the medication dose is increased gradually over 5 weeks until the maximum tolerated dose is reached At the end of each regimen patients are taken off the study drugs over a 12-day tapering period and are off drugs completely for another 2 days
Patients are seen by a doctor or nurse at the 7-week point in each study period After all the drug trials are finished patients repeat the questionnaires they filled out at the beginning of the study Patients and their doctors will be informed of the medications that were effective in each individuals care
Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study
Participants will provide a medical history and occupational and other social information They will undergo a neurological examination routine blood tests and an electrocardiogram and will fill out three questionnaires providing information on daily functioning and psychological well-being
This cross-over study consists of several parts including a baseline study and four different treatment regimens During each part patients keep a daily log in which they rate their pain record other procedures they undergo such as injections and manipulations and record medication side effects
In the first week of the study patients remain on their current medications Any antidepressants or opioids are stopped gradually before starting the drug trials After the first week patients go through the following four drug trials in random order
1 Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg to 100 mg and an inert placebo for morphine An inert placebo is a dummy pill it looks like the test drug but has no active ingredient
2 MS Contin morphine and inert placebo-Patients take MS Contin in doses ranging from 30 mg to 90 mg and an inert placebo for nortriptyline
3 Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone
4 Active placebo and inactive placebo-Patients take an active placebo-in this case benztropine-and an inert placebo An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug-in this case slight sleepiness or dry mouth Benztropine is given at one-third the recommended dosage
For each drug regimen the medication dose is increased gradually over 5 weeks until the maximum tolerated dose is reached At the end of each regimen patients are taken off the study drugs over a 12-day tapering period and are off drugs completely for another 2 days
Patients are seen by a doctor or nurse at the 7-week point in each study period After all the drug trials are finished patients repeat the questionnaires they filled out at the beginning of the study Patients and their doctors will be informed of the medications that were effective in each individuals care
Detailed Description:
Irritation or damage to lumbar nerve roots referred to as lumbar radiculopathy or sciatica is a very common clinical entity with a lifetime prevalence of 1-3 in the adult population Lumbar radiculopathy typically causes back pain and sharp shooting pain in the legs Despite its prevalence and disabling characteristics sciatica has never been selectively studied in drug trials It is plausible to assume that tricyclic antidepressants and opioids which are effective in the treatment of other neuropathic pain syndromes will be beneficial for chronic lumbar radicular pain as well This is a randomized double-blind placebo-controlled four period cross-over study of chronic lumbar radicular pain Patient selection will target men and women of all ethnic backgrounds between the ages of 18 and 65 who have had signs and symptoms of sciatica for 3 months or more Treatments are 1 nortriptyline 25-100 mg 2 morphine MS Contin 30-90 mg 3 nortriptyline 25-100 mg plus morphine MS Contin 30-90 mg 4 combination of an active placebo benztropine 025-1 mg and an inert placebo Patients will be called twice a week to individually titrate doses and monitor side effects The primary outcome measures in this study will be the daily pain scores in the low back in the leg and combined Patients quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36 and Oswestry and the Beck questionnaires Fifty one patients will be enrolled in this study and the duration of the study will be 37 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-D-0076 | None | None | None |