Molecular Pathways Involved in Knee Pain
CompletedNCT04443452
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Knee osteoarthritis (OA) is the most common form of arthritis and the most common cause of knee pain in the world. The rate of knee arthritis is as high as that of cardiac disease and is the most common problem in individuals over the age of 65. Central Sensitization (CS) is a marker of widespread pain sensitivity that can occur throughout the central nervous system distribution, leading to changes in the spinal cord as well as in the brain. The presence of CS increases the complexity of the clinical picture and can negatively affect treatment outcomes. CS is present in \>20% of patients suffering from knee OA indicating that in the majority of individuals suffering with painful knee OA, knee pain should be related to molecular changes in the joint. CS might be also associated with discrete synovial fluid proteomic signatures due to the generation by the joint of chemical mediators (e.g. nerve growth factor) that drive CS, or CS might moderate the relationship between synovial fluid proteomic signatures and symptoms due to alterations in pain processing. The aim of this study is to explore the potential molecular links between pain and structure on knee pain using synovial fluid proteomics. A secondary purpose is to explore the association of knee pain with biomarkers of stress, metabolism and dietary habits. In a single session, ultrasound-guided synovial fluid, blood urine and saliva extraction, clinical assessment, completion of a questionnaire booklet and knee x-rays will be conducted. The clinical assessment will measure three features of central sensitisation (sensitivity to blunt pressure on the most painful knee, changes in pain felt during repeated light pricking of the knee skin, and reduction in pain that accompanies inflation of a blood pressure cuff on the non-dominant arm), features of leg strength (dynamometer, time up-and-go test) and features of balance (sway). Participant involvement at each session is expected to last less than 3 hours. Individual…
Study details
- Official title
- Molecular Pathways Involved in Knee Pain: an Observational Study
- Conditions
- Interventions
- Diagnostic test: Quantitative Sensory Testing
- Radiation: Radiographic Evaluation
- Procedure: Ultrasound-guided Aspiration
- Diagnostic test: Muscle Strength Assessment
- Diagnostic test: Function Assessment (A)
- Diagnostic test: Function Assessment (B)
- Diagnostic test: Balance Assessment
- Sponsor
- University of Nottingham
- Collaborators
- Versus Arthritis
- Start date
- 2020-11-06
- Primary completion
- 2023-12-01
- Sex
- All
- Age range
- from 45 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * have the ability to give informed consent * be 45 years or over * have complaints of knee pain for 3-6 months with or without radiographically established OA (K/L scale score ≥ 1) * have complaints of knee pain for 3-6 months with or without satisfying the non-radiographic American College of Rheumatology criteria for knee OA * are willing to undertake knee synovial fluid aspiration * be able to speak, read, and write in English as all instructions and questionnaires are designed in the English language Exclusion Criteria: * Inability to give informed consent due to cognitive impairment or otherwise - (capacity levels are already established under General Practitioner care) * Inability to understand key aspects of the study due to cognitive impairment or otherwise * Giving history of additional co-morbidities such as cancer, neurological conditions, inflammatory joint diseases including rheumatoid arthritis, diabetic neuropathies, fractures or other conditions causing greater disability than their knee pain * Acute soft tissue injury to the knee within last 3 months before potential recruitment
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04443452