Clinical Trial: Pain Treatment for Sciatica

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Morphine, Nortriptyline and Their Combination in Sciatica Treatment

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

    Detailed Summary: 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.
    Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

    Current 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.

    Original Primary Outcome:

    Current Secondary Outcome:

    • 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.


    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: February 2, 2001
    Date Started: January 30, 2001
    Date Completion: December 12, 2006
    Last Updated: January 24, 2017
    Last Verified: December 12, 2006