NCT02967302

NEUROIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the Knee Joint

NEUROIMPA "Intraarticular Application of Opioids in Chronic Arthritis"

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Hildrun Haibel · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint tissue of chronic arthritis patients following intraarticular (i.a.) injections of morphine, a standard steroid or placebo. The primary hypothesis is that i.a. morphine results in significantly lower pain scores and supplemental analgesic consumption than placebo during the first week after injection, an efficacy comparable to standard i.a. steroid (triamcinolone) medication.

Detailed description

3 arm, double blind, placebo controlled, prospective, mo-nocenter study, which will be conducted in the Department of Rheumatology, Charité University Medicine Berlin, Cam-pus Benjamin Franklin in collaboration with several rheu-matology and orthopedic practices in the Berlin area. Ultra-sound guided synovial needle biopsy and interventions will only be performed at CBF. Eligible patients will be treated with either morphine 3 mg i.a., NaCl 0.9% i.a. or triamcinolone 40 mg i.a. at Baseline. The entire study period will be 2 weeks per patient. Assessment of the primary outcome parameter will be at week 1. The patients will be monitored closely throughout the entire study period with a total of 4 visits (screening, baseline, week 1, week 2). Safety data will be collected in the adverse events form, vital parameters, physical examination and laboratory tests dur-ing the whole study.

Conditions

• Knee Arthritis

Interventions

Type	Name	Description
DRUG	Morphine Sulfate	active intervention
DRUG	Triamcinolone	active control
DRUG	placebo	placebo control

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2016-11-18
• Last updated: 2021-08-03

Locations

1 site across 1 country: Germany