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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43832

Enrollment

Registered

2016-03-03

Start date

2015-12-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

neurogeen inflammatoir pijn syndroom reflex sympathetic dystrophy

Interventions

prednisolon tablets first week: 3 x 10 mg dd sec week: 3 x 5 mg dd third week 1 x 5 mg dd

Eligibility

Age

18 Years to 99 Years

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: not able to comply with follow up visits 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

Design outcomes

Primary

Measure	Time frame
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
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. 6. To determine if there is a group difference in improvement in skin temperature difference as measured on a 5 point scale 7. To determine if there is a group difference in improvement of QOL (quality of life)	—

Measure

Time frame

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. 6. To determine if there is a group difference in improvement in skin temperature difference as measured on a 5 point scale 7. To determine if there is a group difference in improvement of QOL (quality of life)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)