Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-10-31
2023-03-31
Brief Summary
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Detailed Description
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Chronic postoperative pain may be linked to a particular type of pain, that is not only driven by the joint damage itself but by changes in the central nervous system (central pain). Several lines of evidence support this idea, but there is a need for a better understanding of the underlying mechanisms as well as a better tool to differentiate between peripherally- and centrally-augmented knee pain in order to identify who will benefit the most from knee surgery.
To this end, the proposed research is a feasibility study aiming to provide proof of concept for a future main trial. The study combines the diagnostic power of non-invasive imaging with experimental approaches to investigate central pain by modelling the peripheral effects of knee surgery. This will provide novel insights into the contribution of peripheral and central pain mechanisms in knee OA which can pave the way for better treatment results.
This study is expected to last for one year. It is funded by Versus Arthritis Pain Centre and forms part of a wider scientific project aiming at increasing knowledge and understanding of OA pain.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Intra-articular injection of bupivacaine
5 ml of bupivacaine (0.25% w/v)
Intra-articular injection of bupivacaine in the knee joint
25 participants will be allocated to the bupivacaine arm.
Intra-articular injection of sodium chloride
5 ml of sodium chloride (9mg/ml, 0.9% solution for injection)
Intra-articular injection of placebo in the knee joint
25 participants will be allocated to the placebo arm.
Interventions
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Intra-articular injection of bupivacaine in the knee joint
25 participants will be allocated to the bupivacaine arm.
Intra-articular injection of placebo in the knee joint
25 participants will be allocated to the placebo arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Versus Arthritis
OTHER
Aalborg University
OTHER
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Professor Brigitte Scammell
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Central Contacts
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References
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Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
Creamer P, Hunt M, Dieppe P. Pain mechanisms in osteoarthritis of the knee: effect of intraarticular anesthetic. J Rheumatol. 1996 Jun;23(6):1031-6.
Hassan BS, Doherty SA, Mockett S, Doherty M. Effect of pain reduction on postural sway, proprioception, and quadriceps strength in subjects with knee osteoarthritis. Ann Rheum Dis. 2002 May;61(5):422-8. doi: 10.1136/ard.61.5.422.
Arendt-Nielsen L, Egsgaard LL, Petersen KK, Eskehave TN, Graven-Nielsen T, Hoeck HC, Simonsen O. A mechanism-based pain sensitivity index to characterize knee osteoarthritis patients with different disease stages and pain levels. Eur J Pain. 2015 Nov;19(10):1406-17. doi: 10.1002/ejp.651. Epub 2014 Dec 29.
Bird SB, Dickson EW. Clinically significant changes in pain along the visual analog scale. Ann Emerg Med. 2001 Dec;38(6):639-43. doi: 10.1067/mem.2001.118012.
Suokas AK, Walsh DA, McWilliams DF, Condon L, Moreton B, Wylde V, Arendt-Nielsen L, Zhang W. Quantitative sensory testing in painful osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2012 Oct;20(10):1075-85. doi: 10.1016/j.joca.2012.06.009. Epub 2012 Jul 13.
Kurien T, Arendt-Nielsen L, Petersen KK, Graven-Nielsen T, Scammell BE. Preoperative Neuropathic Pain-like Symptoms and Central Pain Mechanisms in Knee Osteoarthritis Predicts Poor Outcome 6 Months After Total Knee Replacement Surgery. J Pain. 2018 Nov;19(11):1329-1341. doi: 10.1016/j.jpain.2018.05.011. Epub 2018 Jun 18.
Zedan Y, Knaggs R, Cooper D, Kurien T, Walsh DA, Auer DP, Scammell BE. Is there a difference in the analgesic response to intra-articular bupivacaine injection in people with knee osteoarthritis pain with or without central sensitisation? Protocol of a feasibility randomised controlled trial. BMJ Open. 2023 Jul 11;13(7):e072138. doi: 10.1136/bmjopen-2023-072138.
Other Identifiers
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19OR016
Identifier Type: -
Identifier Source: org_study_id