Percutaneous Neurostimulation in Knee Osteoarthritis

NCT07637682 | Recruiting DMC

• 1 other identifier: 36265PR60/5/26
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral nerve stimulation (PNS) is a drug-free pain management procedure that uses electrical impulses to target specific nerves and block pain signals. PNS helps decrease perception of pain, providing real answers to patients dealing with chronic knee pain. The case study discussed in this presentation is of the use of PNS targeting the superior lateral genicular nerve and the saphenous nerve for a patient with moderate to severe knee pain from osteoarthritis

Conditions

Neuromodulation; Osteoarthritis (OA) of the Knee

Outcome Measures

Primary Outcomes (1)

• change in visual analogue scale after intervention.

  Change (clinical improvement) in visual analogue scale (VAS) immediately after intervention.

  immediately after intervention.

Study Arms (2)

transcutaneous nerve stimulation using a nerve stimulator to the genicular nerve block

EXPERIMENTAL

Device: nerve stimulation using a nerve stimulator to the genicular nerve

transcutaneous nerve stimulation using a nerve stimulator to the saphenous nerve

EXPERIMENTAL

Device: nerve stimulation using a nerve stimulator to the saphenous nerve

Interventions

nerve stimulation using a nerve stimulator to the saphenous nerve DEVICE

temporary transcutaneous nerve stimulation using a nerve stimulator to the saphenous nerve, with settings 2Hz, 0.2mA, 1ms, where the nerve is stimulated for 4 to 6 minutes.

transcutaneous nerve stimulation using a nerve stimulator to the saphenous nerve

nerve stimulation using a nerve stimulator to the genicular nerve DEVICE

temporary transcutaneous nerve stimulation using a nerve stimulator to the genicular nerve, with settings 2Hz, 0.2mA, 1ms, where the nerve is stimulated for 4 to 6 minutes.

transcutaneous nerve stimulation using a nerve stimulator to the genicular nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults between the ages of 30 and 70 years with a clinical diagnosis of moderate to severe knee OA who suffered knee pain.
• Patients who cannot afford intra-articular injections or radiofrequency ablation (RFA).
• patients who had failed 2 different oral pain medications and 6 weeks of physical therapy.

You may not qualify if:

• Patients with OA show improvement in pain after physiotherapy.
• patients evaluated by an orthopaedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
• pregnant patients.
• patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
• patients with previous trauma, neurological or endocrine diseases like diabetes mellitus, and knee tumors; and patients with inflammatory arthritis.
• people who had received an intra-articular knee injection within the last 6 months.
• Patients with tendon tears, bursitis, or calcified tendonitis as proven by imaging.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta University

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Aliaa Mamdouh Abdelaziz Farag, MD

CONTACT

+201069468486; aliaa.mamdouh@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a prospective, double-blinded, placebo-controlled randomised study. The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

EG (1)