Inflammation Impact on Pain in Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03389906|
Recruitment Status : Unknown
Verified December 2017 by Sten Rasmussen, MD, PhD, Northern Orthopaedic Division, Denmark.
Recruitment status was: Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Osteo Arthritis Knee||Other: Gold||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Approximately 72000, 20-40 my-meter diameter, sterilised gold particles (=20 mg) will be provided in vials (The Berlock® Gold Implants).
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.
- Inflammatory markers [ Time Frame: 8 weeks ]In blood and synovial fluid samples we will measure interleukin (IL)-1beta, IL-6, IL-8, IL-13, TNF-alpha.
- Quantitative sensory testing [ Time Frame: 8 weeks ]Pressure Pain Sensitivity Cuff Pressure Algometry
- 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.
- WOMAC [ Time Frame: 8 weeks ]The WOMAC is a subject-rated instrument that measures Osteoarthritis (OA) symptoms. The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-point scale, from 0 (none) to 4 (extreme).
- PainDetect questionnaire (PD-Q [ Time Frame: 8 weeks ]The PD-Q is a validated, easy to use screening tool that predicts the likelihood of a neuropathic pain component in chronic pain disorders. 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.
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
|Contact: Sten Rasmussen, MD, PhD||+45 25 52 04 firstname.lastname@example.org|
|Contact: Kristian K Petersen, MSc, PhD||+45 31 69 75 email@example.com|
|Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Sten Rasmussen, MD, PhD +45 25 52 04 62 firstname.lastname@example.org|
|Contact: Kirstian K Petersen, MSc, PhD +45 31 69 75 10|
|Study Chair:||Lars Arendt-Nielsen, MD, PhD||Aalborg University|