Clinical trial NCT04782401: The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis
Official title: Comparison of the Effects of Ultrasound Guided Genicular Nerve Block Versus Physical Therapy for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Turkish League Against Rheumatism
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 102
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual analog scale (VAS) score
timeFrame: Pre-intervention, Change from Baseline visual analog scale at 12th weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
timeFrame: Pre-intervention, Change from baseline WOMAC score at 12th weeks
measure: Six minute walk test
timeFrame: Pre-intervention, Change from baseline six minute walk test at 12th weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
citation: 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.