Pain Treatment for Sciatica
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Radiculopathy Sciatica |
Drug: Nortriptyline Drug: Morphine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Morphine, Nortriptyline and Their Combination in Sciatica Treatment |
- 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.
- 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.
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | December 2006 |
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00009672
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00009672 History of Changes |
| Other Study ID Numbers: | 010076 01-D-0076 |
| Study First Received: | February 2, 2001 |
| Last Updated: | September 26, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Low Back Pain Opioid Antidepressant |
Randomized Controlled Trial Analgesic Sciatica |
Additional relevant MeSH terms:
|
Radiculopathy Sciatica Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Neuralgia Pain Neurologic Manifestations Sciatic Neuropathy Mononeuropathies Signs and Symptoms Morphine Nortriptyline Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on September 30, 2016