Understanding Pain Mechanisms in Knee Osteoarthritis

NCT05561010 | Unknown

• 1 other identifier: 19OR016
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis, Knee; Chronic Pain

Keywords

Knee osteoarthritis; Chronic pain

Outcome Measures

Primary Outcomes (2)

• The change from baseline in pain score during the six-minute walk test

  The change from baseline in pain score using the Visual Analogue Scale during the six-minute walk test. (visual analogue scale ranges from 0-100; 0 meaning no pain and 100 worst imaginable pain)

  From baseline to approximately one hour after intra-articular injection with bupivacaine or placebo

• The change from baseline in pain score at rest

  The change from baseline in pain score using the Visual Analogue Scale at rest. (visual analogue scale ranges from 0-100; 0 meaning no pain and 100 worst imaginable pain)

  From baseline to approximately one hour after intra-articular injection with bupivacaine or placebo

Secondary Outcomes (6)

• Quantitative sensory testing (QST)

  Baseline and within 30 minutes after intra-articular injection with bupivacaine or placebo

• Brain functional magnetic resonance imaging (fMRI)

  Baseline and 1 hour after intra-articular injection with bupivacaine or placebo

• Magnetic Resonance Imaging Knee Osteoarthritis Score (MOAKS)

  Baseline

• The number of eligible participants who are recruited and randomised to the study

  Through study completion, an average of 6 months

• A study-specific checklist to assess the feasibility of the randomisation process

  Through study completion, an average of 6 months

Study Arms (2)

Intra-articular injection of bupivacaine

EXPERIMENTAL

5 ml of bupivacaine (0.25% w/v)

Drug: Intra-articular injection of bupivacaine in the knee joint

Intra-articular injection of sodium chloride

PLACEBO COMPARATOR

5 ml of sodium chloride (9mg/ml, 0.9% solution for injection)

Drug: Intra-articular injection of placebo in the knee joint

Interventions

Intra-articular injection of bupivacaine in the knee joint DRUG

25 participants will be allocated to the bupivacaine arm.

Also known as: Bupivacaine hydrochloride

Intra-articular injection of bupivacaine

Intra-articular injection of placebo in the knee joint DRUG

25 participants will be allocated to the placebo arm.

Also known as: Sodium chloride

Intra-articular injection of sodium chloride

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Nottingham: collaborator
• Versus Arthritis: collaborator
• Aalborg University: collaborator

Related Publications (8)

• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.

  PMID: 31034380 BACKGROUND

• 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.

  PMID: 8782136 BACKGROUND

• 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.

  PMID: 11959766 BACKGROUND

• 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.

  PMID: 25545011 BACKGROUND

• 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.

  PMID: 11719742 BACKGROUND

• 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.

  PMID: 22796624 BACKGROUND

• 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.

  PMID: 29920331 BACKGROUND

• 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.

  PMID: 37433734 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Professor Brigitte Scammell

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Yasmine Zedan

CONTACT

01157484389; Yasmine.Zedan3@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: September 30, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share