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

Minimally Invasive Knee Osteoarthritis Pain Control Via Adductor Canal Block Versus Intra-articular Steroid and Lignocaine Injection : a Single-blinded Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Adductor Canal Block; Procedure: Intra-Articular Steroid and Lignocaine Injection

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:

1. 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:

2. To ascertain the functional improvement following Adductor Canal Block versus Intra-Articular Steroid and Lignocaine for chronic Knee Osteoarthritis (KOA)
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adductor Canal Block; Adductor Canal Block (Saphaenous Nerve Block) done under Ultrasonographic guidance with 5cc of Bupivacaine, 5cc of lidocaine diluted with 10 cc of Normal Saline	Procedure: Adductor Canal Block; Ultrasound guided perineural injection of 5cc bupivacaine, 5cc lidocaine and 10 cc Normal saline; Other Names: Saphenous Nerve Block
Active Comparator: Intra-articular Steroid and Lignocaine; Intra-articular knee joint injection of 40mg triamcinolone and 1-2cc of lidocaine	Procedure: Intra-Articular Steroid and Lignocaine Injection; Intra-articular injection of 40mg triamcinolone and 1-2 cc of lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Before intervention, within 1 hour, after 4 weeks, after 12 weeks (change from baseline - before intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before intervention, after 4 weeks , after 12 weeks - measuring change from baseline score (before intervention)at the intervals mentioned
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	Before intervention, after 4 weeks , after 12 weeks - measuring change from baseline score (before intervention)at the intervals mentioned

Collaborators and Investigators

• Sponsor: University of Malaya

Publications and helpful links

General Publications

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• Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23.
• Koh IJ, Choi YJ, Kim MS, Koh HJ, Kang MS, In Y. Femoral Nerve Block versus Adductor Canal Block for Analgesia after Total Knee Arthroplasty. Knee Surg Relat Res. 2017 Jun 1;29(2):87-95. doi: 10.5792/ksrr.16.039.
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• Lee DH, Lee MY, Kwack KS, Yoon SH. Effect of adductor canal block on medial compartment knee pain in patients with knee osteoarthritis: Retrospective comparative study. Medicine (Baltimore). 2017 Mar;96(12):e6374. doi: 10.1097/MD.0000000000006374.
• Eker HE, Cok OY, Aribogan A, Arslan G. The efficacy of intra-articular lidocaine administration in chronic knee pain due to osteoarthritis: A randomized, double-blind, controlled study. Anaesth Crit Care Pain Med. 2017 Apr;36(2):109-114. doi: 10.1016/j.accpm.2016.05.003. Epub 2016 Jul 30.

Helpful Links

• 3. Ministry of Health Malaysia. Clinical Practice Guidelines on the Management of Osteoarthritis. 2010
• Knee Pain and Functional Disability of Knee Osteoarthritis Patients Seen at Malaysian

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): August 27, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 201945-7302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No