Intra-articular Injection of Lidocaine in Inflammatory Arthritis
Primary Purpose
Inflammatory Arthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
depomedrone 40mg/ml + 1% lidocaine
depomedrone 40mg/ml+ 0.9% saline
painDETECT questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Arthritis
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lidocaine plus steroid
Steroid only
Arm Description
Outcomes
Primary Outcome Measures
pain score 5 minutes post-injection
Visual analogue pain score 0-10
Secondary Outcome Measures
Full Information
NCT ID
NCT05302232
First Posted
January 11, 2022
Last Updated
March 29, 2022
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05302232
Brief Title
Intra-articular Injection of Lidocaine in Inflammatory Arthritis
Official Title
Randomised Trial of Intra-articular Injection of Lidocaine Versus Placebo in Inflammatory Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 18, 2022 (Anticipated)
Primary Completion Date
October 18, 2022 (Anticipated)
Study Completion Date
October 18, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised to receive joint injection of either lidocaine plus steroid or, as a control, just steroid injection
Masking
Participant
Masking Description
Treatment allocation will be single blinded, in that the researcher will know what intervention the patient is receiving but the patient will not.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine plus steroid
Arm Type
Experimental
Arm Title
Steroid only
Arm Type
Placebo Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
depomedrone 40mg/ml + 1% lidocaine
Intervention Description
Response to intra-articular injection of lidocaine as a diagnostic marker of peripheral pain
Intervention Type
Diagnostic Test
Intervention Name(s)
depomedrone 40mg/ml+ 0.9% saline
Intervention Description
Response to intra-articular injection of steroid only as a placebo
Intervention Type
Other
Intervention Name(s)
painDETECT questionnaire
Intervention Description
painDETECT questionnaire
Primary Outcome Measure Information:
Title
pain score 5 minutes post-injection
Description
Visual analogue pain score 0-10
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruce Kirkham
Phone
020 7188 5900
Email
bruce.kirkham@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe Rutter-Locher
Phone
020 7188 5900
Email
zrutter-locher@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Kirkham
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intra-articular Injection of Lidocaine in Inflammatory Arthritis
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