Inflammation Impact on Pain in Knee Osteoarthritis

NCT03389906 | Completed DMC

• 1 other identifier: N-20160045
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammation; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• WOMAC

  The WOMAC\[6\] is a subject-rated instrument that measures Osteoarthritis (OA)

  8 weeks, 2 years

Secondary Outcomes (5)

• Quantitative sensory testing

  8 weeks

• Weekly pain diary

  8 weeks

• Inflammatory markers

  8 weeks

• PainDetect questionnaire (PD-Q

  8 weeks, 2 years

• Global Rating of Change Scale

  2 years

Study Arms (1)

Gold

EXPERIMENTAL

Approximately 72000, 20-40 my-meter diameter, sterilised gold particles (=20 mg) will be provided in vials (The Berlock® Gold Implants).

Other: Gold

Interventions

Gold OTHER

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.

Gold

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sten Rasmussen, MD, PhD: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (38)

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• Rasmussen S, Petersen KK, Aboo C, Andersen JS, Skjoldemose E, Jorgensen NK, Stensballe A, Arendt-Nielsen L. Intra-articular injection of gold micro-particles with hyaluronic acid for painful knee osteoarthritis. BMC Musculoskelet Disord. 2024 Mar 12;25(1):211. doi: 10.1186/s12891-024-07321-4.

  PMID: 38475764 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Gold

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Lars Arendt-Nielsen, MD, PhD

  Aalborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Head of Department of Clinical Medicine

Model Details: Pilot study

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 4, 2018
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

DK (1)