Intra-articular Injection of Lidocaine in Inflammatory Arthritis

Randomised Trial of Intra-articular Injection of Lidocaine Versus Placebo in Inflammatory Arthritis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Arthritis
• Intervention / Treatment: Diagnostic test: depomedrone 40mg/ml + 1% lidocaine; Other: painDETECT questionnaire; Diagnostic test: depomedrone 40mg/ml+ 0.9% saline

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruce Kirkham; Phone Number: 020 7188 5900; Email: bruce.kirkham@gstt.nhs.uk
• Study Contact Backup: Name: Zoe Rutter-Locher; Phone Number: 020 7188 5900; Email: zrutter-locher@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine plus steroid	Diagnostic test: depomedrone 40mg/ml + 1% lidocaine; Response to intra-articular injection of lidocaine as a diagnostic marker of peripheral pain; Other: painDETECT questionnaire; painDETECT questionnaire
Placebo Comparator: Steroid only	Other: painDETECT questionnaire; painDETECT questionnaire; Diagnostic test: depomedrone 40mg/ml+ 0.9% saline; Response to intra-articular injection of steroid only as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score 5 minutes post-injection	Visual analogue pain score 0-10	5 minutes

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Bruce Kirkham, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): April 18, 2022
• Primary Completion (Anticipated): October 18, 2022
• Study Completion (Anticipated): October 18, 2022

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lidocaine
• Other Study ID Numbers: 311106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No