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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
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 11, 2022
    Last Updated
    March 29, 2022
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
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    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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