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D-cycloserine in the Management of Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125528
Recruitment Status : Completed
First Posted : August 1, 2005
Results First Posted : February 23, 2015
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

Brief Summary:
Pre-clinical studies in rats suggest that D-cycloserine (DCS) 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 chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of chronic low back pain and to determine which pain measurement scales are best at measuring the efficacy of treatment.

Condition or disease Intervention/treatment Phase
Low Back Pain Pain Drug: D-cycloserine Drug: placebo Phase 2

Detailed Description:

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 escalating dose study comparing D-cycloserine twice a day (bid) with placebo bid in patients with chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 12 weeks with study drug: 50 mg bid DCS or matching placebo for the first 4 weeks, then 100mg bid DCS or matching placebo for 4 weeks and finally 200mg bid DCS or matching placebo for 4 weeks. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
Study Start Date : July 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: 1
D-cycloserine 50mg bid/100mg bid/200 mg bid
Drug: D-cycloserine
D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid

Placebo Comparator: 2
Drug: placebo
placebo bid

Primary Outcome Measures :
  1. Change in Numeric Rating Scale (NRS-11) [ Time Frame: 6 weeks ]
    Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.

Secondary Outcome Measures :
  1. McGill Pain Questionnaire (MPQ) [ Time Frame: 6 weeks ]
    Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have a history of low back pain for a minimum of 6 months with or without 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00125528

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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Thomas J. Schnitzer
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Principal Investigator: Thomas J Schnitzer, M.D., Ph.D. Northwestern University
Principal Investigator: Vania Apkarian, Ph.D. Northwestern University

Additional Information:
Publications of Results:
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Responsible Party: Thomas J. Schnitzer, professor, Northwestern University Identifier: NCT00125528    
Other Study ID Numbers: A1159
First Posted: August 1, 2005    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 10, 2017
Last Verified: December 2016
Keywords provided by Thomas J. Schnitzer, Northwestern University:
chronic pain
low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action