Understanding Pain Mechanisms in Knee Osteoarthritis

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

UP-KNEE study is a feasibility, double-blind, placebo-controlled randomised parallel study in participants with radiographically defined knee OA, and with self-reported chronic knee pain.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nottingham University Hospitals NHS Trust
• Collaborators: Aalborg University; University of Nottingham; Versus Arthritis
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Radiographically defined OA knee changes (K/L > 2);

• Must have self-reported knee pain (measuring at least 30 mm to 80 mm on a 100 mm VAS for rest, use or night pain);

• Able to give informed consent;

• Aged 45 years and older;

• All genders;

• Able to perform the six-minute walk test.

Exclusion Criteria:

• Aged less than 45 years;

• Breastfeeding or pregnancy;

• Not having the capacity to consent;

• Non-English speakers;

• Major medical, neurological and psychiatric co-morbidities;

• Hip OA (ipsilateral or contralateral);

• Fibromyalgia;

• Sensory dysfunctional illness;

• Chronic pain conditions other than OA;

• Presence of local or systemic infection or suspicion of infection in the knee joint, overlying soft tissue or elsewhere;

• History of septic arthritis in the knee to be injected;

• Acute haemarthrosis in the joint to be injected;

• Recent trauma within 72 hours;

• Prosthetic joint;

• Presence of broken skin or rash over the area to be injected;

• Severe coagulopathy (can take aspirin or anti-platelets inhibitors such as clopidogrel);

• Any anti-coagulant therapy (e.g. warfarin);

• Severe liver disease or severe kidney disease;

• Known hypersensitivity, allergy or intolerance to local anaesthetic / bupivacaine;

• Recently taken other medicines containing local anaesthetic / bupivacaine within 1 month;

• Surgery planned within 3 months of entry to study;

• Neuropathic pain medications such as opioid analgesics, antiepileptic drugs such as pregabalin / gabapentin, and tricyclic antidepressants such as amitriptyline when taken for neuropathic pain treatment;

• Current or recent intake centrally-active medication (e.g. have recently taken monoamine oxidase inhibitor (MAOI));

• Complete heart block;

• The presence of any contraindication for MRI.