D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
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|ClinicalTrials.gov Identifier: NCT03535688|
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Pain||Drug: D-cycloserine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain|
|Actual Study Start Date :||March 30, 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||March 2022|
D-cycloserine 200 mg BID (twice daily)
200 mg BID (twice daily)
Placebo Comparator: Placebo
Placebo BID (twice daily)
BID (twice daily)
- Change in Numeric Rating Scale (NRS) pain score [ Time Frame: 12 weeks ]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.
- Gender (male/female) [ Time Frame: 12 weeks ]Assess the effect of gender on magnitude of pain response
- Brain biomarkers (MRI) [ Time Frame: 12 weeks ]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.
- McGill Pain Questionnaire (MPQ) [ Time Frame: 12 weeks ]A 17-item self-reported measure assessing both the quality and intensity of subjective pain.
- painDETECT Questionnaire (PDQ) [ Time Frame: 12 weeks ]A 14-item self-reported measure assessing qualities for pain of neuropathic origin to distinguish pain severity.
- Beck Depression Inventory (BDI) [ Time Frame: 12 week ]A 21-item self-report rating inventory that measures characteristic attitudes and symptoms of depression.
- Positive and Negative Affect Schedule (PANAS) [ Time Frame: 12 weeks ]A self-report questionnaire consisting of two 10-item (5-point) scales to measure both positive and negative affects of pain.
- Pain Catastrophizing Scale (PCS) [ Time Frame: 12 weeks ]
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).
- Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: 12 weeks ]A 32-item self-reported measure delineating between beneficial versus maladaptive interoceptive attention.
- Oswestry Disability Index (ODI) [ Time Frame: 12 weeks ]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.
- SF-12 Health Survey [ Time Frame: 12 weeks ]A 12-item self-report questionnaire measuring functional health and well-being from the patient's point of view.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535688
|Contact: Byron Yip, MScfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Thomas Schnitzer, MD, PhD 312-503-2315|
|Principal Investigator:||Thomas J. Schnitzer, MD, PhD||Northwestern University|