The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain.
This is a 26-week, double-blind, randomized, placebo-controlled two-arm parallel-group trial of d-cycloserine, a pharmacological treatment selected based on positive results from previous preclinical and clinical studies, for the treatment of chronic, refractory low back pain (CBP). After a 2-week screening period, individuals will be randomized to receive either 12 weeks of d-cycloserine or placebo and then followed for an additional 12 weeks to evaluate persistence of benefit at study endpoint, 24 weeks after randomization. During the 12-week treatment period, participants will undergo evaluation at baseline and at clinic visits on weeks 2, 6 and 12 after randomization to assess pain, proper treatment use and side effects. During the subsequent 12-week follow-up period, pain and safety will continue to be assessed monthly by phone calls. All patients will also be assessed daily using an electronic diary (eDiary) to record pain and mood. Magnetic resonance imaging (MRI), anatomical MRI, resting state functional MRI (fMRI), diffusion-tensor imaging (DTI) MRI, and arterial spin labeling (ASL) will be performed at baseline and at the end of 12 weeks for individuals completing MRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
203
200 mg twice daily
twice daily
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Change in Numeric Rating Scale (NRS) pain score 0-10; higher worse
Mean pain levels will be assessed at study baseline and compared to mean pain levels at Week 12 (study efficacy endpoint). Pain will be assessed using an 11-point NRS scale.
Time frame: 12 weeks
Gender (male/female)
Assess the effect of gender on magnitude of pain response
Time frame: 12 weeks
Brain biomarkers (MRI)
Evaluate interaction between the primary endpoint and specified brain biomarkers, with particular attention to corticostriatal connectivity. Whole-brain exploratory analyses will also be used to identify both brain predictors or treatment response and brain reorganization in response to treatment.
Time frame: 12 weeks
Patient Global Assessment
A 5-point scale used to reflect the global impact of pain from the patient's perspective. Score 0-10; higher worse
Time frame: 12 weeks
Patient Global Impression of Change
A 7-point self-report measure that reflects a patient's belief about the efficacy of treatment; by depicting a patient's rating of overall improvement. Score 1-7, higher worse
Time frame: 12 weeks
McGill Pain Questionnaire (MPQ)
A 17-item self-reported measure assessing both the quality and intensity of subjective pain. Score 0-45, higher worse
Time frame: 12 weeks
PainDETECT Questionnaire (PDQ)
A 14-item self-reported measure assessing qualities for pain of neuropathic origin to distinguish pain severity. Score 0-38; higher more neuropathic
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Time frame: 12 weeks
Beck Depression Inventory (BDI)
A 21-item self-report rating inventory that measures characteristic attitudes and symptoms of depression. Score 0-63, higher worse
Time frame: 12 week
Positive and Negative Affect Schedule (PANAS)
A self-report questionnaire consisting of two 10-item (5-point) scales to measure both positive and negative affects of pain. Score 10-50; higher more positive
Time frame: 12 weeks
Pain Catastrophizing Scale (PCS)
A 13-item scale assessing the degree of catastrophic cognitions in the sensation of pain. The scale ranges from 1 (not at all) to 4 (always). Score 0-52, higher worse
Time frame: 12 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)
A 32-item self-reported measure delineating between beneficial versus maladaptive interoceptive attention. Score 0-160, higher more awareness.
Time frame: 12 weeks
Oswestry Disability Index (ODI)
A 10-item self-reported measure quantifying a subjective percentage score of level of function (disability) in activities of daily living in those with chronic low back pain. Score 0-50; higher is greater disability
Time frame: 12 weeks
12-Item Short Form Survey (SF-12)
A 12-item self-report questionnaire measuring functional health and well-being from the patient's point of view. The SF-12 measures patient reported, health related quality of life from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: 12 weeks