TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial
|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.|
|ClinicalTrials.gov Identifier: NCT02031211|
Recruitment Status : Withdrawn (No participants enrolled.)
First Posted : January 9, 2014
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment|
|CRPS Chronic Regional Pain Syndrome||Drug: Etanercept Drug: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Etanercept for the Treatment of Chronic Regional Pain Syndrome|
|Study Start Date :||June 2014|
|Primary Completion Date :||October 2016|
|Study Completion Date :||October 2016|
Placebo Comparator: Placebo
0.4 ml/kg of normal saline will be administered subcutaneously.
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.
Other Name: Normal Saline
Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
Other Name: Enbrel
- Visual Analog Scale [ Time Frame: 8 weeks ]intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups.
- Adolescent Pediatric Pain Tool [ Time Frame: At end of each week of treatment ]The Adolescent Pediatric Pain Tool is a survey that will be administered at baseline and at the end of each of the four weeks of treatment.
- Skin Temperature and Volume of Affected Limb [ Time Frame: At beginning and end of study ]The skin temperature and volume of the affected limb will be measured at the beginning and end of the study.
- Hospital Anxiety and Depression Scale [ Time Frame: Beginning and end of study ]The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study.
- Sleep Disturbance Scale for Children [ Time Frame: Beginning and end of the study ]The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study.
- Sleep pattern and quality [ Time Frame: Daily ]The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031211
|United States, California|
|Palo Alto, California, United States, 94305|