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Completed

NCT Number: NCT04782401

The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis

Goal: Comparison of the effects of genicular nerve block with usg and physical therapy on pain, physical function for patients with knee osteoarthritis.

Material and Methods:102 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study.Patients were randomized to two groups, first being injected a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves with exercise treatment and second being ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer with exercise treatment.For the first group, the ultrasound we used: 12 MHz linear transducer. (Logic E9-GE, USA).The transducer was first placed parallel to the long bone shaft and moved up or down to identify the epicondyle of the long bone. The genicular arteries were identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound.Accordingly, GNB target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve. , Visual Analogue Scale for pain(VAS) was primer outcome measurement, Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC) and six minute walk tests were seconder outcome measurements of the study applied before, after (two weeks) and 12th weeks of treatment. Primer endpoint of the study is decrease at least 40% in VAS values at 2nd week, second endpoint is the improvement in the womac and 6-minute walk test observed in the 2nd week continues until the 12th week.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with knee osteoarthritis according to the 1986 American College of Rheumatology (ACR) criteria and were in Kellgren-Lawrence (KL) Grade 2-3
  • Being between the ages of 45-65

Exclusion criteria

  • Severe knee trauma history within the six month
  • Previous intraarticular hyaluronic acid or steroid injection
  • Previous use of oral glucosamine
  • Meniscal or connective tissue damage
  • Those receiving physical therapy within the six month for knee pain
  • History of inflamatuary romatologic disease
  • Pregnancy and breastfeeding
  • Malignancy
  • Psychiatric disease
  • Those with a pacemaker

Treatment and study plan

Ultrasound guided genicular nerve block + exercise treatment

Other

This method was used to inject a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves plus exercise treatment

Physical therapy + exercise treatment

Device

Ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer and exercise treatment.

Primary outcomes

  1. Visual analog scale (VAS) score

    Time frame: Pre-intervention, Change from Baseline visual analog scale at 12th weeks

    A scale for the use of measuring pain. Minimum score of the scale is 0 and maximum is 10. Higher scores mean worse outcomes.

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

    Time frame: Pre-intervention, Change from baseline WOMAC score at 12th weeks

    WOMAC is a scale to assess disease-related functional status and disability. It consists of three parts with 24 simple questions in total. Five questions are related to pain (WOMAC-A), two questions to morning stiffness (WOMAC-B), and the remaining 17 questions to physical condition (WOMAC-C). Each question is scored using 4-point Likert scale (0= None, 1= Mild, 2= Moderate, 3= Severe, 4= Very severe). Higher scores indicate severe pain, increased stiffness, and functional failure. Minimum score of the scale is 0 and maximum is 100. Higher scores mean worse outcomes.

  2. Six minute walk test

    Time frame: Pre-intervention, Change from baseline six minute walk test at 12th weeks

    It is an objective method to evaluate exercise tolerance. It was performed on an unobstructed bare 30 meters (m) floor where every 3 meters were marked. The patients were allowed to complete the test by reducing their walking speed or stopping and getting some rest, if needed. Maximum walking distance (meters) within six min was measured. Higher distance means better outcome.

Sponsors and collaborators

Lead sponsor

Turkish League Against Rheumatism

Other

Registry information

Official study title

Comparison of the Effects of Ultrasound Guided Genicular Nerve Block Versus Physical Therapy for Knee Osteoarthritis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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