Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02967302
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
DLR German Aerospace Center
Information provided by (Responsible Party):
Hildrun Haibel, Charite University, Berlin, Germany

Brief 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.


Condition or disease Intervention/treatment Phase
Knee Arthritis Drug: Morphine Sulfate Drug: Triamcinolone Drug: placebo Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: NEUROIMPA "Intraarticular Application of Opioids in Chronic Arthritis"
Study Start Date : August 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Morphine Sulfate
Morphine 3 mg intraarticular once at baseline
Drug: Morphine Sulfate
active intervention
Other Name: Morphin Hexal

Active Comparator: Triamcinolone
Triamcinolone 40 mg intraarticular once at baseline
Drug: Triamcinolone
active control
Other Name: Triamcinolon Liechtenstein

Placebo Comparator: Placebo
NaCl 0,9% 5 ml intraarticular at baseline
Drug: placebo
placebo control
Other Name: NaCl 0.9%




Primary Outcome Measures :
  1. Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline [ Time Frame: 1 week ]
    Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline


Secondary Outcome Measures :
  1. Area under the VAS curve (AUC) of VAS pain during the first week until 8 p.m. on day 7 [ Time Frame: 1 week ]
    Area under the VAS curve (AUC) of VAS pain during the first week until 8 p.m. on day 7

  2. Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2 [ Time Frame: 2 weeks ]
    Pain intensity on McGill pain questionnaire (MPQ) at baseline, week 1 and 2

  3. daily activities at baseline, week 1 and 2 [ Time Frame: 2 weeks ]
    daily activities at baseline, week 1 and 2

  4. activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2 [ Time Frame: 2 weeks ]
    activity and mobility of the knee joint (Lysholm Gilquist-Score) at baseline, week 1 and 2

  5. WOMAC scale (before i.a. injections at baseline, week 1 and 2) [ Time Frame: 2 weeks ]
    WOMAC scale (before i.a. injections and at the end of each week)

  6. 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), [ Time Frame: 1 weeks ]
    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),

  7. supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2 [ Time Frame: 2 weeks ]
    supplementary analgesic consumption continuously in the patients diary, recorded at week 1 and 2

  8. 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. [ Time Frame: Screening, Baseline, week 1, 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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. Patients with a history of a severe psychiatric illness, which might interfere with the patient's ability to under-stand the requirements of the study and assessment.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967302


Contacts
Layout table for location contacts
Contact: Hildrun Haibel, PD Dr. +49308445 ext 4414 hildrun.haibel@charite.de
Contact: Denis Poddubnyy, Prof. Dr. +4930450 ext 514544 denis.poddubnyy@charite.de

Locations
Layout table for location information
Germany
Charité CBF Rheumatology Recruiting
Berlin, Germany, 12203
Contact: Hildrun Haibel, PD Dr.    +49308445 ext 4414    hildrun.haibel@charite.de   
Contact: Denis Poddubnyy, Prof. Dr.    +4930450 ext 524544    denis.poddubnyy@charite.de   
Sponsors and Collaborators
Hildrun Haibel
DLR German Aerospace Center
Investigators
Layout table for investigator information
Principal Investigator: Hildrun Haibel, PD Dr Charité CBF, Rheumatology, Berlin, Germany

Layout table for additonal information
Responsible Party: Hildrun Haibel, Priv. Doz. Dr. med. Hildrun Haibel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02967302    
Other Study ID Numbers: NEUROIMPA2015
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan
Keywords provided by Hildrun Haibel, Charite University, Berlin, Germany:
knee arthritis, morphine, local injection, pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists