The effect of intrathecal methylprednisolone on features of central sensitisation in patients with chronic complex regional pain syndrome (CRPS) type one

Not Applicable

Completed

• Conditions: Chronic complex regional pain syndrome type 1 (CRPS I); Signs and Symptoms; Complex regional pain syndrome

• Registration Number: ISRCTN01838427
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20018535 (added 04/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-23
• Study Completion: 2008-02-01
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Patients will be male or female, outpatients aged 18 to 75 years, with a clinical diagnosis of CRPS who are referred to the Leiden University Medical Centre (LUMC):
1. At onset patients must fulfill the criteria for CRPS I. These criteria include:
1.1. The combination of continuing pain
1.2. Allodynia or hyperalgesia
1.3. Rendering the pain disproportionate to any inciting event
1.4. Evidence at some time of oedema
1.5. Changes in skin blood flow
1.6. Abnormal sudomotor activity in the region of the pain
1.7. Absence of a condition which would otherwise account for the degree of pain and dysfunction
2. When entering the study patients must suffer from symptoms and signs indicative of central sensitisation (continuing pain, hyperalgesia and/or allodynia)
3. Patients must have symptoms for more than six months and shorter than six years
4. Use of pain medication must have been stable in the previous four weeks
5. Patients must be willing and able to give informed consent according to the national requirements
6. Patients must report spontaneous pain of at least 5 cm on a visual analogue scale (0 cm represents no pain, 10 cm represents the worst imaginable pain)

Exclusion Criteria

1. Patients are excluded if they can obtain satisfactory relief of symptoms with conventional treatments such as non-steroidal anti-inflammatory drugs (NSAIDs) or paracetamol
2. Patients using oral anticoagulant medication or having an impaired blood coagulation for other reasons
3. Patients suffering from diabetes mellitus
4. Patients with an immunocompromised state
5. Patients with an acute infection
6. Patients with an intracranial space occupying lesion
7. Patients with a thrombocytopenia of less than 50 x 10^9/l
8. Patients with clinically significant psychiatric illness
9. Patients who have a history of alcohol or drug abuse within the past year
10. Patients with a known hypersensitivity to (methyl)prednisolone
11. Patients who are unlikely to comply with study requirements or have a history of poor compliance to medical regimens or study requirements
12. Patients who have received an experimental treatment within the last month
13. Pregnant, nursing women and females of childbearing potential not using oral contraceptives or a medically recognised mechanical means of contraception
14. Patients involved in legal proceedings (claiming compensation for the CRPS I)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of spontaneous pain is evaluated through a 10 cm visual analogue scale (0 cm represents no pain, 10 cm represents the worst imaginable pain). This will be filled in at home in a diary. Primary outcome is pain relief at six weeks.