EUROIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint
- Conditions
- Arthritis of the knee jointM13.1Monoarthritis, not elsewhere classified
- Registration Number
- DRKS00011113
- Lead Sponsor
- Charité Campus Benjamin Franklin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 112
1. Clinically detectable and/or ultrasound-visible knee ef-fusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
2. baseline pain score (on a 100 mm Visual Analogue Scale, VAS) >40 mm;
3. male and female patients, age =18 - 80 years,
4. body weight 50 - 90 kg.
5. Able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be in-cluded in the trial.
6. If female: either not of child-bearing potential (meno-pausal since 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study with a pearl index <1. Reliable methods of contraception are: condoms plus other methods: implants, injecatbles, combined oral contracep-tives, intrauterine devices, initiated at least 90 days prior to screening. Further reliable methods are a vasecto-mised partner (at least 1 year prior to enrolment), sexual-ly abstinent, surgically sterilized (including hysterecto-my), postmenopausal defined as at least 1 year of spon-taneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below 30 nl/l is confirmatory).
7. If male: either not of child-bearing potential (surgically sterilized, e.g. vasectomy) or is willing and able to prac-tice a reliable method of contraception with a pearl index <1 (see inclusion criterium 6) throughout the study.
1. Severe cardiovascular, respiratory, metabolic, neurologi-cal, psychiatric disorders; current bacterial infection es-pecially of the knee
2. abuse of analgesics, benzodiazepines, alcohol; hard drugs”
3. pregnancy, lactation
4. before biopsy thrombocyte count < 100/nl, Quick <50%
5. intake of anticoagulants, anti-aggregants as monothera-py such as ASS 100 will be allowed
6. participation in an investigational trial during the last 30 days or 5 HLT whichever is longer
7. treatment with intraarticular steroids during the past 4 weeks in the selected joint.
8. Any other condition, which might inable the patient from participation in the trial according to the investigators judgement.
9. Patients who are institutionalised due to regulatory or juridical order. Patients who are an employee of the in-vestigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
10. Known hypersensitivity to any component of the study medication to morphine or triamcinolone, ileus, respira-tory depression, severe chronic obstructive airway dis-eases, acute abdomen, coagulopathy and/ or infections of the injection site, instability of the injected joint, psori-atic skin manifestation at the injection site, periarticular calcification, non-vascularized bone necrosis, tendon rupture, Charcot-joint.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline.
- Secondary Outcome Measures
Name Time Method Area under the VAS curve (AUC) VAS Pain during the first week until 8 p.m. on day 7. <br>Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2; <br>daily activities at baseline, week 1 and 2; <br>activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2; WOMAC scale (before i.a. injections and at the end of each week). <br>Inflammatory parameters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFa) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication), supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2.<br>Assessment of safety: <br>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.<br>