NCT07125768

Brief Summary

This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 10, 2025

Last Update Submit

August 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement of knee osteoarthritis pain

    Improvement of knee osteoarthritis pain according to Visual Analogue Scale (VAS). VAS: which was a subjective scale used to quantitatively assess pain (0 = No pain, 10 = Severe pain).

    6 months post-procedure

Secondary Outcomes (2)

  • Improvement of quality of life

    6 months post-procedure

  • Decrease of analgesic requirements of pain control after neurolysis.

    6 months post-procedure

Study Arms (2)

Group I

EXPERIMENTAL

Patients received C-arm guided neurolysis of superior medial \[SM\], superior lateral \[SL\], and inferior medial \[IM\] genicular nerves by thermal radiofrequency.

Other: Thermal Radiofrequency Neurolysis

Group II

ACTIVE COMPARATOR

Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.

Other: Alcoholic Neurolysis

Interventions

Patients received C-arm guided neurolysis of superior medial \[SM\], superior lateral \[SL\], and inferior medial \[IM\] genicular nerves by thermal radiofrequency.

Group I

Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.

Group II

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 40 to 60 years.
  • Both sexes.
  • Stage 3 and 4 knee osteoarthritis in patients who aren't responding to pharmacological treatment and aren't good candidates for knee replacement surgery.

You may not qualify if:

  • Neurological disorders (Previous cerebrovascular stroke, neuropathy, or weakness).
  • Bleeding disorders.
  • Infection at or near the injection site.
  • Presence of a pacemaker or defibrillator.
  • Acute knee injury.
  • Unstable knee joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 15, 2025

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of the study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations