The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782401
• Other study ID #: TRASD-TG-GB
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: January 2022
• Source: Turkish League Against Rheumatism
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 15, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Ultrasound guided genicular nerve block + exercise treatment
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

Device:
• Physical therapy + exercise treatment
Ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer and exercise treatment.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkish League Against Rheumatism

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS) score	A scale for the use of measuring pain. Minimum score of the scale is 0 and maximum is 10. Higher scores mean worse outcomes.	Pre-intervention, Change from Baseline visual analog scale at 12th weeks
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score	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.	Pre-intervention, Change from baseline WOMAC score at 12th weeks
Secondary	Six minute walk test	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.	Pre-intervention, Change from baseline six minute walk test at 12th weeks