Inflammation Impact on Pain in Knee Osteoarthritis
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ClinicalTrials.gov Identifier: NCT03389906 |
Recruitment Status :
Completed
First Posted : January 4, 2018
Last Update Posted : August 12, 2021
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Condition or disease | Intervention/treatment | Phase |
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Inflammation Osteo Arthritis Knee | Other: Gold | Not Applicable |

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 |

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).
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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. |
- WOMAC [ Time Frame: 8 weeks, 2 years ]The WOMAC[6] is a subject-rated instrument that measures Osteoarthritis (OA)
- 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.
- Inflammatory markers [ Time Frame: 8 weeks ]Proteomic analysis of blood and synovial fluid
- 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.
- 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 |
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

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
Denmark | |
Aalborg University Hospital | |
Aalborg, Denmark, 9000 |
Study Chair: | Lars Arendt-Nielsen, MD, PhD | Aalborg University |
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Inflammation Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pathologic Processes |