The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis

NCT ID: NCT04782401

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-02-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Genicular Nerve Block

Group Type: ACTIVE_COMPARATOR

Ultrasound guided genicular nerve block + exercise treatment

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Physical therapy + exercise treatment

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish League Against Rheumatism

OTHER

Sponsor Role: lead

Responsible Party

Dr. Elif becenen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35165769 (View on PubMed)

Other Identifiers

TRASD-TG-GB

Identifier Type: -

Identifier Source: org_study_id