Oral steroids for the treatment of inflammatory Complex Regional Pain Syndrome type-1

Phase 4

Conditions: neurogeen inflammatoir pijn syndroom
reflex sympathetic dystrophy

Registration Number: NL-OMON43832

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

1. CRPS-1 (clinical Budapest criteria) in one arm only.
2. Inflammatory type: painful upper extremity, temperature difference, swelling, red
discoloration, limited hand function.
3. Occurring after trauma or upper extremity surgery
4. Acute stadium of less than 12 months duration
5. Diminished functioning of the upper extremity as established by a DASH score of 10 or more (Hudak, 1996)
6. Average pain score of 3 or more on a one week pain diary, three times daily
7. No indication for surgical therapy or no future surgery planned
8. Age 18-80

Exclusion Criteria

not able to comply with follow up visits
<18 or > 80 years of age
more than one extremity involved
body temperature of > 38 degrees Celsius
Elevated white blood cell count ( > 10-E9/liter)
Elevated BSE and CRP
Associated Infectious disease
Pregnancy
Coagulation disorders, use of anticoagulants
untreated peptic ulcer, hypertension, untreated diabetes, untreated cardiac failure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessment of a group difference in clinically important improvement in<br /><br>functional outcome of at least 10 points as measured by the DASH questionnaire</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To determine if there is a group difference in improvement in global<br /><br>perceive effect of therapy as measured on a 7 point scale<br /><br>2. To determine if there is a group difference in improvement in pain intensity<br /><br>scores as measured by a pain diary three times daily during the week before<br /><br>each study visit.<br /><br>3. To determine if there is a group difference in improvement in edema as<br /><br>measured by a measurement tape<br /><br>4. To determine if there is a group difference in improvement in discoloration<br /><br>as measured on a 3 point scale<br /><br>5. To determine if there is a group difference in cortisol levels of responders<br /><br>to treatment versus non responders.<br /><br>6. To determine if there is a group difference in improvement in<br /><br>skin temperature difference as measured on a 5 point scale<br /><br>7. To determine if there is a group difference in improvement of<br /><br>QOL (quality of life) </p><br>