NCT06060678

Brief Summary

This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). NRS and WOMAC scores will be evaluated before, 1, and 3 months after the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 25, 2023

Last Update Submit

November 25, 2023

Conditions

Knee Pain Chronic

Keywords

OsteoarthritisPainUltrasonographyParesthesia

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale (NRS)

    Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.

    Change from Baseline NRS at 1 and 3 months

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Change from Baseline WOMAC at 1 and 3 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients who underwent genicular nerve alcohol neurolysis for knee osteoarthritis pain

You may qualify if:

  • Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
  • Permanent pain for more than 6 months
  • Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
  • Pain with conservative methods such as analgesics and physiotherapy treatment failure

You may not qualify if:

  • History of intra-articular knee intervention in the last 6 months
  • Cognitive impairment
  • Hepatic or renal insufficiency
  • Severe psychiatric illness
  • Local or systemic infection
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OsteoarthritisPainParesthesia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Study Officials

  • Gevher Rabia Genc Perdecioğlu

    Diskapi TRH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

September 25, 2023

First Posted

September 29, 2023

Study Start

May 9, 2023

Primary Completion

November 1, 2023

Study Completion

November 5, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

TU(1)