Chronic Regional Pain Syndrome, CRPS
Conditions
Brief summary
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.
Interventions
DRUGEtanercept
The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
DRUGPlacebo
The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age. 2. 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. 3. Duration of symptoms less than 4 months.
Exclusion criteria
1. Active malignancy or history of malignancy. 2. Active infection. 3. History of Tuberculosis (TB) or TB exposure. 4. Pregnancy. 5. Concomitant disease causing immunocompromise. 6. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease. 7. Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder. 8. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age. 9. Evidence of or history of demyelinating disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 8 weeks | intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adolescent Pediatric Pain Tool | 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 | 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 | 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 | 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 | Daily | The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality. |
Countries
United States
Outcome results
None listed