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| Name | Class |
|---|---|
| DLR German Aerospace Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine Sulfate | Experimental | Morphine 3 mg intraarticular once at baseline |
|
| Triamcinolone | Active Comparator | Triamcinolone 40 mg intraarticular once at baseline |
|
| Placebo | Placebo Comparator | NaCl 0,9% 5 ml intraarticular at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine Sulfate | Drug | active intervention |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline | Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the VAS curve (AUC) of VAS pain during the first week until 8 p.m. on day 7 | Area under the VAS curve (AUC) of VAS pain during the first week until 8 p.m. on day 7 | 1 week |
| Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hildrun Haibel, PD Dr | Charité CBF, Rheumatology, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité CBF Rheumatology | Berlin | 12203 | Germany |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D014221 | Triamcinolone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Triamcinolone | Drug | active control |
|
|
| placebo | Drug | placebo control |
|
|
Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2 |
| 2 weeks |
| daily activities at baseline, week 1 and 2 | daily activities at baseline, week 1 and 2 | 2 weeks |
| activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2 | activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2 | 2 weeks |
| WOMAC scale (before i.a. injections at baseline, week 1 and 2) | WOMAC scale (before i.a. injections and at the end of each week) | 2 weeks |
| nflammatory parameters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before i.a. medication at baseline and week 1), | nflammatory parameters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication), | 1 weeks |
| supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2 | supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2 | 2 weeks |
| Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded continuously in the patients diary, recorded at week 1 and week 2. | Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded continuously in the patients diary, recorded at week 1 and 2. | Screening, Baseline, week 1, week 2 |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |