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Inflammation Impact on Pain in Knee Osteoarthritis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389906
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : August 12, 2021
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Sten Rasmussen, MD, PhD, Northern Orthopaedic Division, Denmark

Brief Summary:
The aim of this study is to use gold particles as a model compound to modulate specifically and selectively the function of macrophages and mast cells and investigate how this modulates pain and pain sensitization in the osteoarthritic knee assessed by mechanistic pain assessment technologies

Condition or disease Intervention/treatment Phase
Inflammation Osteo Arthritis Knee Other: Gold Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inflammation Impact on Pain in Patients With Knee Osteoarthritis
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Gold
Approximately 72000, 20-40 my-meter diameter, sterilised gold particles (=20 mg) will be provided in vials (The Berlock® Gold Implants).
Other: Gold
Approximately 72000, 20-40 my-meter diameter, sterilised gold particles (=20 mg) will be provided in vials (The Berlock® Gold Implants). 5-10 ml of synovial fluid is aspirated (20G needle) from most affected OA-knee. The vial of gold particles are mixed with the synovial fluid, and the mix of gold and synovial fluid is injected intra-articularly into the patients knee.




Primary Outcome Measures :
  1. WOMAC [ Time Frame: 8 weeks, 2 years ]
    The WOMAC[6] is a subject-rated instrument that measures Osteoarthritis (OA)


Secondary Outcome Measures :
  1. Quantitative sensory testing [ Time Frame: 8 weeks ]
    Pressure Pain Sensitivity Cuff Pressure Algometry

  2. Weekly pain diary [ Time Frame: 8 weeks ]

    Subjects rated their pain intensity on a VAS scale every day at home. On the VAS scale ''0" indicates ''no pain", and ''10" indicates ''maximal pain".

    Subjects rated the pain severity for:

    Average Pain Score (APS) for the last 24 hours Worst pain for the last 24 hours Pain severity at night.


  3. Inflammatory markers [ Time Frame: 8 weeks ]
    Proteomic analysis of blood and synovial fluid

  4. PainDetect questionnaire (PD-Q [ Time Frame: 8 weeks, 2 years ]
    The PD-Q is a validated, easy to use screening tool that predicts the likelihood of a neuropathic pain component in chronic pain disorders[14]. It shows higher sensitivity and specificity in comparison with other neuropathic pain screening questionnaires. The questionnaire is comprised of 3 major components: gradation of pain, pain course pattern and radiating pain. There are 7 questions evaluating gradation of pain. Each question is scored by the patient using a 0 to 5 score with 0 = never, 1 = hardly notice, 2 = slightly, 3 = moderately, 4 = strongly and 5 = very strongly. There is one question evaluating pain course pattern. Patients select from one of four pictures to indicate which pattern of pain best describes their course of pain. Each picture is associated with a unique score of 0, -1, or +1 (2 pictures have this score possible). There is one question evaluating radiating pain with a yes (score of +2) or no (score of 0) response option.

  5. Global Rating of Change Scale [ Time Frame: 2 years ]
    we asked the question, "Concerning your knee, how will you describe yourself compared to immediately before injection of gold into your knee" and evaluated the answer at an 11-point scale from very much worse (-5) to complete recovered (5).



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Knee OA diagnosed based on the American College of Rheumatology criteria, KL (Kellgren-Lawrence) X-ray grade ≧ 2, pain for > 3months, maximal pain intensity VAS (visual analogue scale) ≧ 5 (0-10 scale) for the most painful knee during the last week. Knee joint effusion that can be aspirated

Exclusion Criteria:

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial e.g. analgesics, anti-inflammatory drugs
  • Recent history of acute pain affecting the lower limb and/or trunk
  • Past history of a chronic pain condition
  • Participation in other pain trials throughout the study period

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): NCT03389906


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Sten Rasmussen, MD, PhD
Aalborg University
Investigators
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Study Chair: Lars Arendt-Nielsen, MD, PhD Aalborg University
Publications of Results:
Forestier J. Rheumatoid arthritis and its treatment by gold salts. The lancet 1934;224:646-648.
Guy W, Bonato RR. Manual for the ECDEU assessment battery. : US Department of Health, Education, and Welfare, National Institute of Mental Health, 1970

Other Publications:
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Responsible Party: Sten Rasmussen, MD, PhD, Professor Head of Department of Clinical Medicine, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT03389906    
Other Study ID Numbers: N-20160045
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Inflammatory markers may be shared with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After publication information is available.
Access Criteria: At the reasonable request to Sten Rasmusssen. (sten.rasmussen@rn.dk;s_rasmussen@dcm.aau.dk

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes