Anti-TNF-alpha (Infliximab) in Complex Regional Pain Syndrome.

Completed

• Conditions: Acute CRPS type 1 with inflammatory signs

• Registration Number: NL-OMON21058
• Lead Sponsor: Erasmus MC, Department of Anesthesiology, Rotterdam, The Netherlands

Brief Summary

Summary – conclusions:<br> There were problems with the patient inclusion from the start of the study due to several factors. Eventually only 13 patients could be included before the end of the study period, and all were analyzed: 7 in the intervention group and 6 in the placebo group. <br><br> Efficacy Results:<br> Despite the very small study we found an effect on inflammatory mediators, especially TNF&#945;, and on quality of life, but not on other secondary parameters. <br><br> Safety Results:<br> One serious adverse event was reported in the placebo group of this trial. The relationship to the treatment was classified as ‘other’. In the intervention group no serious adverse events were reported.<br> The registration of the adverse advents shows 28 adverse events in the infliximab group, compared to 51 in the placebo group. Only in 2 cases (one with a transitory increased blood pressure, and one with constipation), this was ‘probably’ related to infliximab. <br> Although the study was very small, and the patients were carefully selected, this indicates that infliximab is a safe treatment for patients with regional inflammation in the acute stage of CRPS. <br><br> Conclusion:<br> In spite of the small number of participants a promising trend towards an effect of infliximab on the initially high TNF&#945; concentration, as well as on the quality of life in patients with a neuroinflammation in acute CRPS has been found. Unfortunately this study has been terminated before the required number of participants for sufficient power was reached, so we cannot draw any definitive conclusions. Therefore, a follow-up study into the effect of Remicade on the clinical signs of inflammation in CRPS with more participants is recommended.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Men and women between 18 and up until 65 years. Established diagnosis of CRPS-1 according to the Bruehl / Budapest criteria.

Are considered eligible according to tuberculosis screening criteria.

Exclusion Criteria

1. Disease related reasons;

2. Abnormal laboratory findings;

Study & Design

• Study Type: Interventional
• Study Design: Not specified