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Adductor Canal Block Versus Intra-articular Steroid and Lignocaine in Knee Osteoarthritis Pain Management

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Adductor Canal Block
Intra-Articular Steroid and Lignocaine Injection
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Symptomatic Knee Osteoarthritis according to criteria of American College of Rheumatology

    • Antero-medial knee pain of at least 6 months duration
    • Matching symptoms with Knee X-ray findings of KOA
    • Kellgran-Lawrence staging of 2-4
    • Pain score of at least NRS(Numerical Rating Scale) 4/10 during weight bearing

Exclusion Criteria:

  • Presence of other knee diseases such as fracture or rheumatic diseases
  • Referred pain from the back suggestive of lumbar radiculopathy
  • Previous knee surgery
  • Lateral knee pain
  • History of knee joint injections (Intra-articular injections or ACB) within 3 months of study
  • Neuropathic knee pain
  • Unable to give consent

Sites / Locations

  • University Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adductor Canal Block

Intra-articular Steroid and Lignocaine

Arm Description

Adductor Canal Block (Saphaenous Nerve Block) done under Ultrasonographic guidance with 5cc of Bupivacaine, 5cc of lidocaine diluted with 10 cc of Normal Saline

Intra-articular knee joint injection of 40mg triamcinolone and 1-2cc of lidocaine

Outcomes

Primary Outcome Measures

Knee Pain score change
Change from baseline Pain Score On weight Bearing using numerical rating scale (Visual Analog Scale / Numerical Rating Scale : from 0 to 10, 0 being the absence of pain with maximum score of 10 indicating most severe pain - increasing value given indicates more severe pain)

Secondary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire - Functional component score change
Self administered questionnaire - patients answer a series of 17 questions : answers are based on 5 responses utilizing a Likert scale and scored base on this formula 100 - [Mean Score (A1-A17)×100 / 4] As long as at least 50% of the subscale items are answered for each subscale, a mean score can be calculated The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire - Quality of Life component score change
Self administered questionnaire - patients answer a series of 4 questions : answers are based on 5 responses utilizing a Likert scale and scored base on this formula 100 - [Mean Score (Q1-Q4)×100 / 4] As long as at least 50% of the subscale items are answered for each subscale, a mean score can be calculated The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems

Full Information

First Posted
November 8, 2019
Last Updated
January 16, 2021
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT04264481
Brief Title
Adductor Canal Block Versus Intra-articular Steroid and Lignocaine in Knee Osteoarthritis Pain Management
Official Title
Minimally Invasive Knee Osteoarthritis Pain Control Via Adductor Canal Block Versus Intra-articular Steroid and Lignocaine Injection : a Single-blinded Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, single blinded interventional study will be conducted in the Rehabilitation Medicine Clinic, University Malaya Medical Center for a duration of 1 year. Eligible subjects will be enrolled from all referrals of chronic knee osteoarthritis, following computer-generated randomization they will be allocated to either Adductor Canal Block (intervention) or Intra-articular Steroid and Lignocaine (control) groups. The assessor is blinded to the intervention received, which will be performed by an experienced interventionist, not participating in randomization or data collection and analysis. Demographics of participants, duration of symptoms, Numerical Rating Score (NRS) pain score and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire score will be recorded prior to injection, 1 week, 1 month and 3 months post injection. Mann-Whitney U tests and Chi-Square test of association will be used as appropriate to compare groups at baseline. Numerical Rating Scale (NRS) pre and post intervention will be analyzed using paired t-test. Functional outcome and Quality of Life (QoL) subset of Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire pre and post intervention will be analyzed using paired t-test as well
Detailed Description
BACKGROUND Knee osteoarthritis (KOA) pain is major public health issue globally causing locomotor disability affecting around 251 million people worldwide according to the Global Burden of Disease 2010 Study. In Malaysia, KOA prevalence is 10% to 20% of the elderly population and negatively affects physical function especially limitation in walking (22%), carrying objects (18.6%), and dressing (12.8%). Mild to moderate KOA pain is managed with anti-inflammatory drugs and knee replacement surgery is recommended when pharmacotherapy fails. However, 81% of the patients would refrain from undergoing surgery as it is expensive. Currently there is no effective pharmaceutical treatments for KOA pain & functional disability. Most studies with regards to adductor canal block for KOA pain are done in the immediate post-operative period with only 3 studies looking into ACB in the chronic KOA population: 1 case report and 2 retrospective studies. Thus, there is a need for head to head comparison between Adductor Canal Block (ACB) and Intra-Articular Steroid and Lignocaine (IASL). OBJECTIVES Primary objective: Investigate the reduction in pain score following adductor canal block in comparison to intra-articular steroid and lignocaine in chronic Knee Osteoarthritis (KOA) pain. Secondary objectives: To ascertain the functional improvement following Adductor Canal Block versus Intra-Articular Steroid and Lignocaine for chronic Knee Osteoarthritis (KOA) To evaluate the Quality of life improvement following Adductor Canal Block versus Intra-Articular Steroid and Lignocaine for chronic Knee Osteoarthritis METHOD A prospective, single blinded interventional study will be conducted in the Rehabilitation Medicine Clinic, University Malaya Medical Center for a duration of 1 year. Eligible subjects will be enrolled from all referrals of chronic knee osteoarthritis, following computer-generated randomization they will be allocated to either Adductor Canal Block (intervention) or Intra-Articular Steroid and Lignocaine (control) groups. The assessor is blinded to the intervention received, which will be performed by an experienced interventionist, not participating in randomization or data collection and analysis. Demographics of participants, duration of symptoms, Numerical Rating Score (NRS) pain score and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire score will be recorded prior to injection, 1 week, 1 month and 3 months post injection. Mann-Whitney U tests and Chi-Square test of association will be used as appropriate to compare groups at baseline. Numerical Rating Scale (NRS) pre and post intervention will be analyzed using paired t-test. Functional outcome and Quality of Life (QoL) subset of Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire pre and post intervention will be analyzed using paired t-test as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigator blinded to intervention
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor Canal Block
Arm Type
Experimental
Arm Description
Adductor Canal Block (Saphaenous Nerve Block) done under Ultrasonographic guidance with 5cc of Bupivacaine, 5cc of lidocaine diluted with 10 cc of Normal Saline
Arm Title
Intra-articular Steroid and Lignocaine
Arm Type
Active Comparator
Arm Description
Intra-articular knee joint injection of 40mg triamcinolone and 1-2cc of lidocaine
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block
Other Intervention Name(s)
Saphenous Nerve Block
Intervention Description
Ultrasound guided perineural injection of 5cc bupivacaine, 5cc lidocaine and 10 cc Normal saline
Intervention Type
Procedure
Intervention Name(s)
Intra-Articular Steroid and Lignocaine Injection
Intervention Description
Intra-articular injection of 40mg triamcinolone and 1-2 cc of lidocaine
Primary Outcome Measure Information:
Title
Knee Pain score change
Description
Change from baseline Pain Score On weight Bearing using numerical rating scale (Visual Analog Scale / Numerical Rating Scale : from 0 to 10, 0 being the absence of pain with maximum score of 10 indicating most severe pain - increasing value given indicates more severe pain)
Time Frame
Before intervention, within 1 hour, after 4 weeks, after 12 weeks (change from baseline - before intervention)
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire - Functional component score change
Description
Self administered questionnaire - patients answer a series of 17 questions : answers are based on 5 responses utilizing a Likert scale and scored base on this formula 100 - [Mean Score (A1-A17)×100 / 4] As long as at least 50% of the subscale items are answered for each subscale, a mean score can be calculated The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems
Time Frame
Before intervention, after 4 weeks , after 12 weeks - measuring change from baseline score (before intervention)at the intervals mentioned
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire - Quality of Life component score change
Description
Self administered questionnaire - patients answer a series of 4 questions : answers are based on 5 responses utilizing a Likert scale and scored base on this formula 100 - [Mean Score (Q1-Q4)×100 / 4] As long as at least 50% of the subscale items are answered for each subscale, a mean score can be calculated The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems
Time Frame
Before intervention, after 4 weeks , after 12 weeks - measuring change from baseline score (before intervention)at the intervals mentioned

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic Knee Osteoarthritis according to criteria of American College of Rheumatology Antero-medial knee pain of at least 6 months duration Matching symptoms with Knee X-ray findings of KOA Kellgran-Lawrence staging of 2-4 Pain score of at least NRS(Numerical Rating Scale) 4/10 during weight bearing Exclusion Criteria: Presence of other knee diseases such as fracture or rheumatic diseases Referred pain from the back suggestive of lumbar radiculopathy Previous knee surgery Lateral knee pain History of knee joint injections (Intra-articular injections or ACB) within 3 months of study Neuropathic knee pain Unable to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwar Suhaimi, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.moh.gov.my/index.php/file_manager/dl_item/6257467262485674595851676447567961326c7561533945636d466d6446394455456466543045756347526d
Description
3. Ministry of Health Malaysia. Clinical Practice Guidelines on the Management of Osteoarthritis. 2010
URL
http://www.medic.upm.edu.my/upload/dokumen/2017090710491402_MJMHS_Vol13_No2_2017_-_0016_-_p7-15_4th_proof.pdf
Description
Knee Pain and Functional Disability of Knee Osteoarthritis Patients Seen at Malaysian

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Adductor Canal Block Versus Intra-articular Steroid and Lignocaine in Knee Osteoarthritis Pain Management

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