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CompletedNCT04782401Updated Feb 7, 2022

The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis

An interventional study of Ultrasound guided genicular nerve block + exercise treatment and Physical therapy + exercise treatment in Knee Osteoarthritis, sponsored by Turkish League Against Rheumatism. Completed at 1 site in Turkey. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Turkish League Against Rheumatism · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Knee Osteoarthritis
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 102 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Turkish League Against Rheumatism is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Genicular Nerve Block

    Other: Ultrasound guided genicular nerve block + exercise treatment

  • Active comparator
    Physical Therapy

    Device: Physical therapy + exercise treatment

Interventions

  • OtherUltrasound 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

  • DevicePhysical 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 site
  • Ankara City Hospital
    Ankara, 06800, Turkey
08

References and documents

Publications

  • 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. PubMed 35165769 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04782401
Lead sponsor
Turkish League Against Rheumatism
Responsible party
Dr. Elif becenen (Principal investigator, Turkish League Against Rheumatism) — Principal investigator
First posted
Mar 4, 2021
Start date
Mar 1, 2020
Primary completion
Feb 1, 2021
Completion
Feb 15, 2021
Last update
Feb 7, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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