Intra-articular Injection of Lidocaine in Inflammatory Arthritis

NCT05302232 | Unknown

• 1 other identifier: 311106
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Inflammatory Arthritis

Outcome Measures

Primary Outcomes (1)

• pain score 5 minutes post-injection

  Visual analogue pain score 0-10

  5 minutes

Study Arms (2)

Lidocaine plus steroid

EXPERIMENTAL

Diagnostic Test: depomedrone 40mg/ml + 1% lidocaine; Other: painDETECT questionnaire

Steroid only

PLACEBO COMPARATOR

Diagnostic Test: depomedrone 40mg/ml+ 0.9% saline; Other: painDETECT questionnaire

Interventions

depomedrone 40mg/ml + 1% lidocaine DIAGNOSTIC_TEST

Response to intra-articular injection of lidocaine as a diagnostic marker of peripheral pain

Lidocaine plus steroid

depomedrone 40mg/ml+ 0.9% saline DIAGNOSTIC_TEST

Response to intra-articular injection of steroid only as a placebo

Steroid only

painDETECT questionnaire OTHER

painDETECT questionnaire

Lidocaine plus steroid; Steroid only

Eligibility Criteria

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

You may qualify if:

• Diagnosis of peripheral inflammatory joint disease
• Reporting current NRS pain ≥3 on a 0-10 scale
• Only perform this test when an aspiration and joint injection is clinically indicated and would be given as part of routine care

You may not qualify if:

• Under 18 years of age
• Unable or unwilling to provide informed written consent
• Unable to comply with study protocols
• Pregnancy and breastfeeding
• If the chosen joint has been aspirated or injected in the preceding 3 months
• Presence of joint damage in chosen joint as assessed by Professor Kirkham on x-ray of the chosen joint (as joint damage itself can stimulate peripheral nociceptors)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Related Publications (1)

• Rutter-Locher Z, Norton S, Denk F, McMahon S, Taams LS, Kirkham BW, Bannister K. A randomised controlled trial of the effect of intra-articular lidocaine on pain scores in inflammatory arthritis. Pain. 2024 Nov 1;165(11):2578-2585. doi: 10.1097/j.pain.0000000000003291. Epub 2024 Jun 17.

  PMID: 38888846 DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Bruce Kirkham

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Kirkham

CONTACT

020 7188 5900; bruce.kirkham@gstt.nhs.uk

Zoe Rutter-Locher

CONTACT

020 7188 5900; zrutter-locher@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatment allocation will be single blinded, in that the researcher will know what intervention the patient is receiving but the patient will not.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to receive joint injection of either lidocaine plus steroid or, as a control, just steroid injection

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 31, 2022
• Study Start: April 18, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share