The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis

NCT04782401 | Completed

• 1 other identifier: TRASD-TG-GB
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

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

• Six minute walk test

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

Study Arms (2)

Genicular Nerve Block

ACTIVE COMPARATOR

Other: Ultrasound guided genicular nerve block + exercise treatment

Physical Therapy

ACTIVE COMPARATOR

Device: Physical therapy + exercise treatment

Interventions

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

Genicular Nerve Block

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.

Physical Therapy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish League Against Rheumatism: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Guler T, Yurdakul FG, Onder ME, Erdogan F, Yavuz K, Becenen E, Uckun A, Bodur H. Ultrasound-guided genicular nerve block versus physical therapy for chronic knee osteoarthritis: a prospective randomised study. Rheumatol Int. 2022 Apr;42(4):591-600. doi: 10.1007/s00296-022-05101-8. Epub 2022 Feb 14.

  PMID: 35165769 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 15, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)