TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Etanercept for the Treatment of Chronic Regional Pain Syndrome

Conditions
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CRPS, Chronic Regional Pain Syndrome

Intervention / Treatment
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* Drug: Etanercept
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age. Patients must meet CRPS Type I diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb ≥1.0°C. Duration of symptoms less than 4 months. Exclusion Criteria: Active malignancy or history of malignancy. Active infection. History of Tuberculosis (TB) or TB exposure. Pregnancy. Concomitant disease causing immunocompromise. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease. Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age. Evidence of or history of demyelinating disease.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0.4 ml/kg of normal saline will be administered subcutaneously. | Drug: Placebo<br>* The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.<br>* Other names: Normal Saline;|
| Experimental: Etanercept<br>Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly. | Drug: Etanercept<br>* The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |