Double-blind randomised placebo-controlled cross-over study to investigate the safety and effectiveness of intrathecal glycine on pain and dystonia in Complex Regional Pain Syndrome type 1

Completed

• Conditions: Complex regional pain syndrome type 1 (CRPS I); Musculoskeletal Diseases; Other disorders of bone

• Registration Number: ISRCTN75413193
• Lead Sponsor: eiden University Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients must fulfil the diagnostic criteria of the consensus report of CRPS I:
1.1. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event
1.2. Evidence at some time of edema, changes in skin blood flow or abnormal sudomotor activity in the region of the pain
1.3. No condition that would otherwise account for the degree of pain and dysfunction
2. Patients must suffer from clinically significant tonic or intermittent dystonia in one or more extremities
3. Patients must have symptoms for at least 1 year

Exclusion Criteria

1. Patients are excluded if they can obtain satisfactory relief of symptoms with conventional treatments
2. Patients with a history of alcohol or drugs abuse within the past year
3. Patients with clinically significant psychiatric illness
4. Pregnant, nursing women and females of childbearing potential not using effective contraception
5. Patients who are unlikely to comply with study requirements or have a history of poor compliance to medical regimens or study requirements
6. Patients with an insufficient command and understanding of the Dutch language
7. Patients involved in legal proceedings (claiming compensation for their CRPS I)

Study & Design

• Study Type: Interventional
• Study Design: Not specified