Phase 2
N=41
D-cycloserine in the Management of Chronic Low Back Pain
Low Back Pain · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00125528 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Change in Numeric Rating Scale (NRS-11) — -2.47; -1.55 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- D-cycloserine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas J. Schnitzer
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numeric Rating Scale (NRS-11) |
-2.47; -1.55 | — |
| SECONDARY McGill Pain Questionnaire (MPQ) |
-2.80; -1.00 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00125528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.