Oral steroids for the treatment of inflammatory CRPS-1

oral steroids for the treatment of inflammatory CRPS-1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27326

Enrollment

Registered

2015-08-28

Start date

2015-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

complex regional pain syndrome type-1

Interventions

prednisolon versus placebo

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Not able to comply with follow up visits 2. 80 years of age 3. More than one extremity involved 4. Body temperature of ¡Ý 38 degrees Celsius 5. Elevated white blood cell count (> 10-E9 / liter) 6. Elevated BSE or CRP 7. Associated Infectious disease 8. Peptic ulcer 9. Pregnancy 10. Coagulation disorders, use of anticoagulants 11. Untreated hypertension 12. Untreated diabetes 13. Untreated cardiac failure 14. Current steroid use 15. Liver or kidney failure

Design outcomes

Primary

Measure	Time frame
Primary Objective: Assessment of a group difference in clinically important improvement in functional outcome of at least 10 points as measured by the DASH questionnaire	—

Secondary

Measure	Time frame
Secondary Objective(s): 1. To determine if there is a group difference in improvement in global perceive effect of therapy as measured on a 7 point scale 2. To determine if there is a group difference in improvement in pain intensity scores as measured by a pain diary three times daily during the week before each study visit. 3. To determine if there is a group difference in improvement in edema as measured by a measurement tape 4. To determine if there is a group difference in improvement in discoloration as measured on a 3 point scale 5. To determine if there is a group difference in cortisol levels of responders to treatment versus non responders. A responder is a subject who has at least 10 points improvement in the DASH questionnaire	—

Measure

Time frame

Secondary Objective(s): 1. To determine if there is a group difference in improvement in global perceive effect of therapy as measured on a 7 point scale 2. To determine if there is a group difference in improvement in pain intensity scores as measured by a pain diary three times daily during the week before each study visit. 3. To determine if there is a group difference in improvement in edema as measured by a measurement tape 4. To determine if there is a group difference in improvement in discoloration as measured on a 3 point scale 5. To determine if there is a group difference in cortisol levels of responders to treatment versus non responders. A responder is a subject who has at least 10 points improvement in the DASH questionnaire

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Contacts

Public ContactYzabel Vandevivere

Hilvarenbeekse weg 60

y.vandevivere@elisabeth.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)