| CTRI Number |
CTRI/2022/05/042903 [Registered on: 30/05/2022] Trial Registered Prospectively |
| Last Modified On: |
22/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Other |
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Public Title of Study
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To ascertain the effectiveness of ultrasound-guided Adductor Canal Block in patients with knee osteoarthritis having antero-medial knee pain, and it’s comparison with Standard of Care,which will give evidence based direction to clinicians to choose an effective and safe therapeutic option.
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Scientific Title of Study
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Comparative evaluation of the effectiveness of Adductor Canal Block versus Standard of Care for the management of antero-medial knee pain in knee Osteoarthritis |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Anil Sharma |
| Designation |
PG Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Physical Medicine & Rehabilitation, Research Rehabilitation Centre,Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
Department of Physical Medicine & Rehabilitation, Research Rehabilitation Centre,Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
7568412857 |
| Fax |
|
| Email |
anil1983doctor@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Anil Sharma |
| Designation |
PG Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Physical Medicine & Rehabilitation, Research Rehabilitation Centre,Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
Department of Physical Medicine & Rehabilitation, Research Rehabilitation Centre,Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
7568412857 |
| Fax |
|
| Email |
anil1983doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrinal Joshi |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Physical Medicine & Rehabilitation, Research Rehabilitation Centre,Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
Department of Physical Medicine & Rehabilitation, Research Rehabilitation Centre,Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
0141-2561906 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
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Source of Monetary or Material Support
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| Sawai Man Singh Medical College, Jaipur |
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Primary Sponsor
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| Name |
Sawai Man Singh Medical College Jaipur |
| Address |
Sawai Man Singh Medical College,
JLN Marg,
Jaipur-302004
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| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anil Sharma |
Sawai Man Singh Medical College and Hospital, Jaipur. |
Department of Physical Medicine and Rehabilitation, Sawai Man Singh Medical College, Jaipur.
Jaipur
RAJASTHAN |
7568412857
anil1983doctor@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTE SMS MEDICAL COLLEGE JAIPUR |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Current standard of care i.e. conservative management |
The patients with knee arthralgia will be interviewed and examined and if they fulfill the inclusion/exclusion protocol, will further undergo a standardized history taking, physical examination, blood investigations, x-rays and recording of outcome measures.
All will be offered an initial standard of care i.e. conservative management for a period of two weeks, with the advice to return for follow up. Paracetamol will be prescribed for first line use, with Etoricoxib as second line of treatment according to the protocol. They will be instructed to keep a count on number of tablets ingested every day and will be included in the Standard of Care Group.
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| Intervention |
Ultrasonography-guided Adductor Canal Block injection |
The patients in the Intervention Group will receive an ultrasonography-guided single Adductor Canal Block injection. The thigh will be prepared and draped according to standard sterile techniques. Adductor Canal Block will be performed in the mid to proximal thigh on medial aspect, using a linear transducer being placed transverse to the longitudinal axis of leg and curved probe in case of patients with high BMI.The saphenous nerve would be identified, underneath the Sartorius muscle as is descends lateral to the femoral artery in the Adductor Canal (Hunter Canal or Sub Sartorial Canal).Then a mixed solution containing 9 ml of 2% Lidocaine and 1ml of 40mg/ml Triamcinolone acetonide with a 22 gauze spinal anaesthesia needle will be injected in the Adductor Canal. |
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Inclusion Criteria
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| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Those willing to give an informed written consent to participate in study.
2. Those diagnosed as having symptomatic knee osteoarthritis (according to the clinical criteria of the American College of Rheumatology)
3. Those with Grade of Kellgren – Lawrence grading scale 2 to 4 of Knee Osteoarthritis.
THE CLINICAL CRITERIA OF THE AMERICAN COLLEGE OF RHEUMATOLOGY
Knee pain along with at least 3 of the following 6 items classifies Knee Osteoarthritis:
(a) Age > 50 years (b) Stiffness<30 minutes (c) Crepitus
(d) Bony tenderness (e) Bony enlargement (d) No palbable warmth
4. Those with complain of moderate to severe antero-medial knee pain for at least 3 months duration and tenderness on antero-medial aspect of the knee.
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| ExclusionCriteria |
| Details |
1. Those with Grade of Kellgren – Lawrence grading scale 1 of Knee Osteoarthritis.
2. Those having medical and surgical co morbidities that can influence treatment protocol eg. Fracture of long bone, diabetes mellitus, ligament injury, lumbar radiculopathy, peripheral nerve disorder, PID etc.
3. Any medical or surgical condition preventing communication and compliance of study protocol eg. Cognitive impairment, TBI, hearing impairment, psychiatric illness etc.
4. Pregnant / lactating females.
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| Outcome |
TimePoints |
To compare the outcomes of the two groups, the one receiving Adductor Canal Block and the other receiving Standard of Care, for the effectiveness of two therapeutic modalities on antero-medial knee pain in knee osteoarthritis,using
1. Visual Analogue Scale (VAS) for knee pain intensity;
2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);
3. The Timed up and Go Test (TUG);
4. The number of analgesics ingested per day.
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0,2,4,8 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
To evaluate the functional improvement in knee osteoarthritis patients treated with ultrasound- guided Adductor Canal Block using
1.The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);
2.The Timed up and Go Test(TUG) |
0,2,4,8 weeks |
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Target Sample Size
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Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
01/06/2022 |
| 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 |
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Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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No Publication Details as yet... |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
AIM
To ascertain the effectiveness of
ultrasound-guided Adductor Canal Block in patients with knee osteoarthritis
having antero-medial knee pain, and it’s comparison with Standard of Care.
OBJECTIVES
Primary Objective:
To compare the
outcomes of the two groups, the one receiving Adductor Canal Block and the
other receiving Standard
of Care, for the effectiveness of two
therapeutic modalities on antero-medial knee pain in knee osteoarthritis.
Secondary Objective:
To evaluate the
functional improvement in knee osteoarthritis patients treated with ultrasound-
guided Adductor Canal Block.
This study hypothesizes that the adductor canal block achieves better pain relief
than Standard of Care i.e. conservative
management in knee osteoarthritis patients with antero-medial knee pain.
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