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 : June 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Pain||Drug: D-cycloserine Drug: Placebo||Phase 2|
|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 :||February 2022|
|Estimated Study Completion Date :||August 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.
- Patient Global Assessment [ Time Frame: 12 weeks ]A 5-point scale used to reflect the global impact of pain from the patient's perspective.
- Patient Global Impression of Change [ Time Frame: 12 weeks ]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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03535688
|Contact: Byron Yip, MScemail@example.com|
|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|