| City: |
|
Chicago |
|
State:
|
|
IL |
| Zip Code: |
|
60611 |
| Conditions: |
|
Low Back Pain - Pain |
| Purpose: |
|
Pre-clinical studies in rats suggest that D-cycloserine is effective in the management of
chronic neuropathic pain. This pilot study will attempt to determine the effect of
D-cycloserine in the treatment of neuropathic chronic low back pain. Other aims of this
study are to determine the safety of D-cycloserine in the treatment of neuropathic chronic
low back pain and to determine which pain measurement scales are best at measuring the
efficacy of treatment.
|
| Study summary: |
|
Human brain imaging studies indicate that the medial prefrontal cortex activity can predict
more than 80% of the variance of chronic back pain intensity. Therefore, the investigators
have hypothesized that modulation of brain activity at this site should result in analgesia.
D-cycloserine has been shown to potentiate conditioned fear extinction. Based on this the
investigators hypothesize that chronic neuropathic pain (back pain with radiculopathy) is
partially mediated or potentiated by decreased ability to extinguish the pain memory, which
the investigators hypothesize to be mediated through reward/aversion brain circuitry, and
specifically through medial prefrontal cortex. They have tested this idea in pre-clinical
studies and demonstrated that rats with neuropathic pain show analgesia over the long-term
when treated with D-cycloserine. In humans with chronic back pain, the investigators
hypothesize that D-cycloserine will enhance extinction of back pain which in turn should
result in reduced emotional relevance of the pain, that is reduced suffering. It is quite
possible that the overall intensity of the back pain will be unaffected, however, the
associated suffering will be significantly attenuated.
This will be a double-blind, randomized, parallel group study comparing D-cycloserine at
250mg twice a day (bid) with placebo bid in patients with neuropathic chronic low back pain.
Subjects meeting inclusion criteria will continue baseline medications and be treated for 4
weeks with study drug, followed by a 2 week blinded placebo treatment period and a
subsequent 4 weeks of treatment with the same study drug as the initial treatment period.
Assessments of efficacy and safety will be undertaken every 2 weeks using standard,
validated instruments to evaluate change in pain, function, quality of life and adverse
events. |
| Criteria: |
|
Inclusion Criteria:
- Must have a history of low back pain for a minimum of 6 months with radiation of pain
to leg or buttocks.
- Must be 18 years of age.
- Must have a visual analogue scale (VAS) pain score >50 mm
- Must be in generally stable health
- Must be willing to abstain from drinking alcohol during the course of the study.
- If female, must be post-menopausal for at least one year or practicing an accepted,
highly effective method of contraception or abstinence and plan to continue either
during the course of the study.
- Must be able and willing to read and understand instructions as well as
questionnaires
- Must sign an informed consent document after complete explanation of the study
documenting that they understand the purpose of the study, procedures to be
undertaken, possible benefits, potential risks, and are willing to participate.
Exclusion Criteria:
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
fibromyalgia, history of surgery or tumor in the back.
- Involvement in litigation regarding their back pain or have a disability claim or are
receiving workman's compensation or seeking either as a result of their low back pain
- Neurologic disorder, including history of seizures
- Major psychiatric disorder during the past 6 months
- Moderate or severe depression as determined by the Beck Depression Inventory or any
active suicidal ideation
- Significant other medical disease such as unstable diabetes mellitus, congestive
heart failure, coronary or peripheral vascular disease, chronic obstructive lung
disease, or malignancy
- Significant renal disease or severe renal insufficiency
- History of, or current, substance abuse/dependence including alcohol
- Significantly abnormal laboratory values
- Pregnant or lactating at any time during the course of the study
- Known sensitivity to D-cycloserine
- Currently taking any of the following medications: ethionamide, dilantin, isoniazid
(INH), pyridoxine (vitamin B6)
- In the judgment of the investigator, unable or unwilling to follow the protocol and
instructions
- Any change in medication for back pain in the last 30 days. |
|
|
|
| Study is available at: |
|
Northwestern University Feinberg School of Medicine
Chicago, IL 60611
United States
Primary Contact:
Thomas J Schnitzer, MD, PhD
Email: tjs@northwestern.edu
Phone: 312-503-2315 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|