RadiculopathyPhase 2NCT00009672
Pain Treatment for Sciatica
A Phase 2 study testing Nortriptyline and Morphine in people with Radiculopathy and Sciatica, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Radiculopathy, Sciatica
- What is being tested?
- Nortriptyline and Morphine
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2001to 12 Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In this study chronic lumbar radicular signs and symptoms are defined as pain located in the lower lumbar spine corresponding to L1 and below for at least 3 months with radicular characteristics, i.e. pain described as sharp, burning, with numbness and/or tingling.
- Ability to understand the study measures and mentally capable of give consent to participate in the study (based on an 8th grade education level)
- Willingness to refrain from taking opioids other than their study medication.
- Patients with failed back syndrome who satisfy the criteria outlined in Appendix II.
- Patients with a pain level of 4/10 or greater on a scale of 0 to 10.
Who cannot join
- Major coexisting medical condition such as cancer, chronic obstructive pulmonary disease and severe hepatic and renal dysfunction.
- Prostatic disease requiring usage of urological medications.
- Pregnancy or lactation.
- Unwillingness to discontinue pain medication(s) at study onset as follows: narcotic pain medications, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs) and monoamine oxidase inhibitors (MAOIs).
- Presence of pain of greater intensity in any other location than the low back or leg.
- Current major depression requiring usage of antidepressants.
Show all 17Show fewer
- History of narcotic abuse at any time in the past and/or drug or alcohol abuse in the past year.
- History of narrow angle glaucoma.
- History of epilepsy.
- Current symptoms of coronary artery disease.
- History of fibromyalgia as described by Wolfe F et al., (1990) (a minimum of 12 out of 19 points of tenderness must be present to satisfy criteria for fibromyalgia).
- History of spinal unstability (based on an MRI finding of grade II spondylolisthesis or greater).
- Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits.
- Unwillingness to use adequate contraception (such as birth control pills or barrier methods with spermicide simultaneously).
- Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease.
- Allergy to any of the medications used in the study.
- Age 18 years or less due to rarity of sciatica in this age group.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Morphine, Nortriptyline and Their Combination in Sciatica Treatment
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.
Read more
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:
- 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.)
- 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.
- Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone.
- 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 individual's care.
Read the 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 leg(s). 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 (0.25-1 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.
- Conditions
- Radiculopathy, Sciatica
- Being tested
- Nortriptyline, Morphine
- Keywords
- Low Back Pain, Opioid, Antidepressant, Randomized Controlled Trial, Analgesic, Sciatica
- Medical subject headings
- Radiculopathy, Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NortriptylineDrug
MorphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.
Secondary outcomes (2)
End of each treatment period: Pain symptoms, Use of other meds,Use of other non-meds, questionnaires, Oswestry and Beck Depression, Disability,Patients' global satisfaction with the study medications during the period.
End of Study: Patient preference.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study start30 Jan 2001
- Study completion12 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009672
- Sponsor's protocol ID
- 010076
- Other IDs
- 01-D-0076
- Status last verified
- 12 Dec 2006
- First submitted
- 2 Feb 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Dellemijn P. Are opioids effective in relieving neuropathic pain? Pain. 1999 Apr;80(3):453-462. doi: 10.1016/S0304-3959(98)00256-5.
PubMed 10342407
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine, Nortriptyline and Their Combination in Sciatica Treatment
- ClinicalTrials.gov ID
- NCT00009672
- Acronym / sponsor ID
- 010076
- Conditions
- Radiculopathy, Sciatica
- Keywords
- Low Back Pain, Opioid, Antidepressant, Randomized Controlled Trial, Analgesic, Sciatica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 30 Jan 2001
- Study completion
- 12 Dec 2006
- First posted
- 5 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.)
- 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.
- Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone.
- 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 individual's 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 leg(s). 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 (0.25-1 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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In this study chronic lumbar radicular signs and symptoms are defined as pain located in the lower lumbar spine corresponding to L1 and below for at least 3 months with radicular characteristics, i.e. pain described as sharp, burning, with numbness and/or tingling.
- Ability to understand the study measures and mentally capable of give consent to participate in the study (based on an 8th grade education level)
- Willingness to refrain from taking opioids other than their study medication.
- Patients with failed back syndrome who satisfy the criteria outlined in Appendix II.
- Patients with a pain level of 4/10 or greater on a scale of 0 to 10.
Key exclusion criteria (17 listed)
- Major coexisting medical condition such as cancer, chronic obstructive pulmonary disease and severe hepatic and renal dysfunction.
- Prostatic disease requiring usage of urological medications.
- Pregnancy or lactation.
- Unwillingness to discontinue pain medication(s) at study onset as follows: narcotic pain medications, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs) and monoamine oxidase inhibitors (MAOIs).
- Presence of pain of greater intensity in any other location than the low back or leg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nortriptyline | Drug | – |
| Morphine | Drug | – |
Primary outcome
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.
2 secondary outcomes
End of each treatment period: Pain symptoms, Use of other meds,Use of other non-meds, questionnaires, Oswestry and Beck Depression, Disability,Patients' global satisfaction with the study medications during the period.
End of Study: Patient preference.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 10342407Dellemijn P. Are opioids effective in relieving neuropathic pain? Pain. 1999 Apr;80(3):453-462. doi: 10.1016/S0304-3959(98)00256-5.
Related trials for Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nortriptyline and Morphine in people with Radiculopathy and Sciatica, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily overall pain level, pain in the low back and pain in the lower extremities will be rated on a scale of 0 to 10.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00009672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.