Clinical Trials Logo

Clinical Trial Summary

To assess the contributions of peripheral neurons to joint pain, the investigators plan to ask patients to rate the pain in their chosen joint before and after an injection of local anaesthetic (lidocaine) and steroid into their joint. Lidocaine blocks voltage gated sodium channels (VGSCs) leading to a reversible block of action potential propagation in peripheral nerves. If the pain intensity reduces significantly following lidocaine injection, it suggests that the patients' pain is due to peripheral sensitization, and that this is dampened by the local anaesthetic. If the pain intensity does not change or only falls slightly, then other centrally mediated factors are contributing to pain. Before the investigators can use this method, the investigators need to ensure that reductions in pain score following joint injection are not due to placebo effect. Therefore, as part of this validation study patients will be randomised to receive either lidocaine plus steroid or, as a control, just steroid injection. The steroid is the main part of therapy as it relieves inflammation over a prolonged period, but is slower acting than lidocaine, and should not have an effect within ten minutes. Any improvement in ranking of pain within 10 minutes by patients receiving just steroid will therefore be due to placebo effect. The investigators hypothesis is that there will be a significant difference in change in pain score before and after injection between the study group (lidocaine plus steroid) and control group (0.9% saline plus steroid). This will confirm the absence of a significant placebo effect and mean the differences in change in pain scores seen in the study group are due to differences in pain processing


Clinical Trial Description

Patients will be randomised to receive joint injection of either lidocaine plus steroid or, as a control, just steroid injection. Pain scores (visual analogue score 0-10) in the chosen joint will be collected prior to injection and at 3, 5 and 10 minutes post injection. Pain scores will then again be collected at 1 month and 3 months to determine whether lidocaine reduced peripheral pain long term. Intra-articular joint injection with steroids is a frequent procedure in usual care and the investigators will only perform this test when a joint injection +/- aspiration is clinically indicated. Use of lidocaine in addition to steroid injection varies between rheumatologists, with 50% of Guys' and St Thomas' Hospital rheumatologists routinely using lidocaine and steroid, and others giving steroid alone. Therefore, all patients will still receive the same intervention they would if they were not taking part in the study, the only difference is measurement of pain scores before and after. In addition to collection of pain scores, the investigators will collect patient demographics and painDETECT questionnaire, a screening questionnaire which has been validated to identify neuropathic elements of pain in patients with IA. The investigators hypothesis is that there will be a significant difference in change in pain score before and after injection between the study group (lidocaine plus steroid) and control group (0.9% saline plus steroid). This will confirm the absence of a significant placebo effect and mean the differences in change in pain scores seen in the study group are due to differences in pain processing. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05302232
Study type Interventional
Source Guy's and St Thomas' NHS Foundation Trust
Contact Bruce Kirkham
Phone 020 7188 5900
Email bruce.kirkham@gstt.nhs.uk
Status Not yet recruiting
Phase N/A
Start date April 18, 2022
Completion date October 18, 2022

See also
  Status Clinical Trial Phase
Terminated NCT04249817 - Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care N/A
Not yet recruiting NCT06162195 - The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement N/A
Completed NCT01303874 - Etanercept and Methotrexate in Patients to Induce Remission in Early Arthritis (EMPIRE) Phase 4
Active, not recruiting NCT03343171 - Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study
Recruiting NCT04426747 - Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis
Active, not recruiting NCT04956380 - Self-assessment Triage in Inflammatory Arthritis N/A
Active, not recruiting NCT02538757 - Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE) Phase 2
Completed NCT01874067 - C-GLOVES: the Effectiveness of Compression Gloves in Arthritis
Completed NCT03140995 - Sleep and Exercise in Rheumatoid Arthritis N/A
Withdrawn NCT02027298 - Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study Phase 2
Recruiting NCT00512239 - Prognostic Evaluation of Inflammatory Polyarthritis of Recent Onset
Terminated NCT03937856 - Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases N/A
Completed NCT02436785 - Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening? N/A
Completed NCT02538341 - Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) Phase 2
Completed NCT02465879 - Allied Health in Rheumatology Triage Project N/A
Completed NCT03672916 - Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Completed NCT04806867 - Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia
Active, not recruiting NCT01307384 - Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study
Terminated NCT03672370 - PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
Not yet recruiting NCT05216757 - Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) Phase 2/Phase 3