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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264481
• Other study ID #: 201945-7302
• Status: Completed
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: August 27, 2020

Study information

• Verified date: January 2021
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Adductor Canal Block
Ultrasound guided perineural injection of 5cc bupivacaine, 5cc lidocaine and 10 cc Normal saline
• Intra-Articular Steroid and Lignocaine Injection
Intra-articular injection of 40mg triamcinolone and 1-2 cc of lidocaine

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (13)

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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. Review. — View Citation

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* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External 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