Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

University of Las Palmas de Gran Canaria

Status: Completed

Conditions: Knee Prosthesis

Treatments: Device: Non-invasive Neuromodulation; Device: Placebo Non-invasive Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06134999

PRONES

Details and patient eligibility

About

It will consist of a randomized clinical trial with a control group. The sample will be distributed as homogeneously as possible into two groups, which will be randomly divided into a control group, to which the usual general treatment will be applied, and an experimental group, which will be treated with the NESA XSignal device. During the procedure, the subjects will continue to receive the usual care routine.

Full description

The main objective will be to evaluate the efficacy of the NESA XSignal device in relation to the improvement of pain, functionality and quality of life in patients who have undergone total knee replacement surgery.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age
• Total knee replacement surgery at the Hospital San Juan de Dios de Tenerife.
• Be able to freely consent to take part in the study.

Exclusion criteria

• No contraindications for treatment with NXSignal: pacemakers, internal bleeding, poor skin condition with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or electricity phobia.
• Patients with total knee prosthesis of more than 3 months of evolution.
• Patients with total knee prosthesis with complications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Non-invasive Neuromodulation

Experimental group

Description:

Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Treatment:

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

Placebo Comparator group

Description:

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.

Treatment:

Device: Placebo Non-invasive Neuromodulation