TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

Not Applicable

Withdrawn

• Conditions: CRPS; Chronic Regional Pain Syndrome
• Interventions: Drug: Placebo; Drug: Etanercept

• Registration Number: NCT02031211
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Study Start: 2014-06
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.4 ml/kg of normal saline will be administered subcutaneously.
Etanercept	Etanercept	Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States