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Identification of inflammatory mediators in spinal liquor and the knee in relation to synovial nerve sprouting and pain in osteoarthritis

Identification of inflammatory mediators in spinal liquor and the knee in relation to synovial nerve sprouting and pain in osteoarthritis - OAPII

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49579
Enrollment
165
Registered
2020-05-28
Start date
2021-06-24
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Osteoarthritis

Interventions

Patients will be invited to fill out pain questionnaires pre-operative, and at 6 weeks, 6 months, 1 year after TKR. Pain characteristics and neuroplastic changes will be assessed by quantitative senso
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Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the  following criteria: • At least 18 years of age • OA-patients: Be eligible for TKR under spinal anaesthesia, according to routine clinical  practice. • Controls: Be eligible for anterior cruciate ligament (ACL) operation under spinal anaesthesia, according to routine clinical practice.• Able and willing to give written informed consent

Exclusion criteria

Exclusion criteria: • Auto-immune disease or diabetes mellitus because they may also affect the sensory system. • Use of (pain) medication other than acetaminophen/paracetamol, NSAIDs and/or opioids. • Polyneuropathy or other neurologic disease that might affect outcome measures. • Major cognitive or psychiatric disorders. • Problems with communication (language, deafness, aphasia etc.)

Design outcomes

Primary

MeasureTime frame
We will dichotomize the cohort on the following three outcome parameters to assess whether the the biological measurements/mediators are different between the dichotomised subgroups. Knee VAS and widespread pain are measured prior to TKR, and at 6 weeks, 6 months, and 1 year after TKR but only specific timepoints are used yo dichotomize the cohort. 1. Self-reported knee pain severity at the time of TKR: severe pain (VAS >=40/100 at rest) versus limited pain (knee VAS 10) versus no persisting pain (knee VAS at rest =

Secondary

MeasureTime frame
Independent continues variables: -Quantitative sensory testing (QST) QST will be conducted at the index knee and 2 other body area*s (arm and lower leg) and includes. 1. cold pain thresholds (index knee, lower leg, arm); 2. heat pain thresholds (index knee, lower leg, arm); 3. pressure pain threshold to cutaneous blunt stimuli (index knee, lower leg, arm); 4. cuff pressure pain threshold (both lower legs); 5. Summation of Thermal (heat) (index knee; arm); 6. Summation of Mechanical cuff pressure pain (lower leg); 7. Conditioned pain modulation - Pain assessment, questionnaires: 1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) 2. Measure of intermittent and constant osteoarthritis pain (ICOAP). 3. Graded Chronic Pain Scale (GCPS) 4. Paindetect Other biological measures -Metabolomics: -Innervation knee tissue

Countries

Netherlands

Contacts

Public ContactH.L.D.M. Willemen

Universitair Medisch Centrum Utrecht

h.l.d.m.willemen@umcutrecht.nl0610505072

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026