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No participants enrolled.
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Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.4 ml/kg of normal saline will be administered subcutaneously. |
|
| Etanercept | Experimental | Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adolescent Pediatric Pain Tool | 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. | At end of each week of treatment |
| Skin Temperature and Volume of Affected Limb |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Placebo | Drug | The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously. |
|
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The skin temperature and volume of the affected limb will be measured at the beginning and end of the study. |
| At beginning and end of study |
| Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study. | Beginning and end of study |
| Sleep Disturbance Scale for Children | The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study. | Beginning and end of the study |
| Sleep pattern and quality | The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality. | Daily |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |