| CTRI Number |
CTRI/2024/01/061287 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study whether the addition of lignocaine, a local anesthetic (pain relieving) drug, to steroid which is being given by direct injection into the joint have any benefit in cases of arthritis. |
|
Scientific Title of Study
|
Comparison of Intra-articular corticosteroids with and without intra articular local anesthesia in patients with chronic inflammatory arthritis: a randomised control trail with paired-design. |
| Trial Acronym |
LIJO: Stands for "LIgnocaine in JOint injection" |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Dhir |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room number 6, faculty offices Department of Internal Medicine, f block, 4th floor, nehru hospial, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872229998 |
| Fax |
|
| Email |
varundhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varun Dhir |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Room number 6, faculty offices Department of Internal Medicine, f block, 4th floor, nehru hospial, PGIMER
CHANDIGARH
160012
India |
| Phone |
8872229998 |
| Fax |
|
| Email |
varundhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raveesh Bamigatti |
| Designation |
Junior Resident Department of Internal Medicine |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Internal Medicine, f block, 4th floor, nehru hospial, PGIMER
CHANDIGARH
160012
India |
| Phone |
8296739138 |
| Fax |
|
| Email |
ravish1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Internal Medicine PGIMER Chandigarh 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Internal MEdicine |
| Address |
Department of Internal Medicine, nehru hospital, PGIMER Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varun Dhir |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Room No 3035 Rheumatology Clinic (Wednesday and Friday), New OPD Block, PGIMER
Chandigarh
CHANDIGARH |
8872229998
varundhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Postgraduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, (2) ICD-10 Condition: M468||Other specified inflammatory spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Corticosteroid Alone |
Intraarticular Corticosteroid (No added Lignocaine) |
| Intervention |
Lignocaine 2% + corticosteroid |
Intraarticular injections of Lignocaine + corticosteroid; Lignocaine 2% 5 ml into large joints (shoulder and knee) and 2 ml into medium joints (ankle and elbow) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed as a case of rheumatoid arthritis or spondyloarthritis
2. Having bilateral symmetrical swollen joints - either both shoulders or knees or ankles or elbows planned for joint injections |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in study
2. Allergy to Lignocaine or Methyl-Prednisolone acetate
3. Joints are damaged
4. Inability of the patient to be able to understand or give pain scores
5. Non-symmetrical joint involvement (Symmetry as assessed by physician)
6. Standard exclusion for any intra-articular steroids including Septic-arthritis or overlying skin infection,Coagulopathy, Joint Prosthesis, Intra-articular fracture |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in joint-pain |
1-hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Procedural pain between the IAC+LA versus IAC alone |
immediate |
| Improvement in Joint-pain at 1-day between the IAC+LA versus IAC alone |
1 day |
| Improvement in Joint-pain at 1-week between the IAC+LA versus IAC alone |
1 week |
| Relapse rates at 3 months post intra articular injection |
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Joint Injections of corticosteroid are routinely practised in patients with inflammatory arthritis like rheumatoid arthritis and spondyloarthritis. Routinely inflamed joints like shoulders, kinees, ankles and elbows are done. These lead to rapid relef. However, just after giving the injection it takes times for the corticosteroid to act, and sometimes it may also cause an increase in joint pain for a few days due to steroid crystals leading to inflammation. Addition of lignocaine, which is a local anaesthetic agent to the corticosteroid being injected into the joint is practised at some centers. The logic of this addition is its ability to lead to rapid improvement (within minutes) and also the prevention of joint flares. However, this has not been investigated by a trail We propose to compare whether the addition of the local anaesthetic agent mixed to the corticosteroid before giving the joint injection will benefit the short and medium term improvement which the patient feels with this intervention and whether there is any difference in the remission rates over a longer term of 3-months. We plan a paired-design, that is we will include only those patients whose paired joints have to be injected and then inject one of these joints with corticosteroid alone and one with addition oflignocaine to the corticosteroid. This paired design will standardise the pain felt by each patient and lead to a better and easier comparison of which arm is doing better. |