NCT04100707

Brief Summary

In patients with knee pain, local anesthetics and radiofrequency applications to superolateral, superomedial and inferomedial genicular nerves that innervate the knee joint are also preferred methods besides analgesic and physical therapy. When necessary, total knee replacement is the preferred method for primary knee arthrosis. However, continuing knee pain is reported in approximately 20% of patients after total knee replacement. In similar cases; In the painful knees, the blockages of the genicular nerves are successfully applied. In this study; the efficacy of imaging-guided radiofrequency application will be investigated in patients presenting with knee pain after total knee replacement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

14 days

First QC Date

September 17, 2019

Last Update Submit

September 20, 2019

Conditions

Keywords

Genicular nerveKnee painUltrasound

Outcome Measures

Primary Outcomes (1)

  • Post intervention analgesic effect

    Post intervention analgesic effects of genicular block on patients will be recorded. Postoperative pain, digital evaluation scale (Visual analogue scale -VAS; 0= absence of pain, 100= unbearable pain) of all patients will be performed and recorded.

    at first 3 months

Secondary Outcomes (1)

  • Ultrasound versus fluoroscopy

    at first 3 months

Study Arms (2)

Operated

EXPERIMENTAL

Genicular block will aply to the patients with knee pain who was operated before

Procedure: Genicular block was applied

Nonoperated

SHAM COMPARATOR

Genicular block will aply to the patients with knee pain who wasn't operated before

Procedure: Genicular block was applied

Interventions

This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions

NonoperatedOperated

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee pain

You may not qualify if:

  • with communication problems (VAS and WOMAC scores could not be evaluated)
  • infectious-mechanical pain-related conditions,
  • with radicular pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Teaching and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 24, 2019

Study Start

September 20, 2019

Primary Completion

October 4, 2019

Study Completion

November 4, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations