Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

NCT06134999 | Completed

• 1 other identifier: PRONES
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Prosthesis

Keywords

Total Knee Replacement; physical therapy modality; Electric Stimulation, Transcutaneous

Outcome Measures

Primary Outcomes (3)

• Change in Pain assessed by VAS

  The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".

  Baseline and up to four weeks

• Change in WOMAC questionnaire

  The WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire measures quality of life, in terms of Symptomatology and Physical Disability, in people with osteoarthrosis of the hip or knee. It contains 24 items grouped into 3 scales: pain (0-20), stiffness (0-8), functional capacity (0-68). The scales are used separately, they are not added together. Each item is answered with a 5-level verbal-type scale that is coded: None = 0; Little = 1; Quite a lot = 2; A lot = 3; Very much = 4.

  Baseline and up to four weeks

• Change in the quality of life test

  The EuroQol questionnaire will be used: a generic instrument for measuring health-related quality of life that can be used both in relatively healthy individuals (general population) and in groups of patients with different pathologies. The individual him/herself assesses his/her state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each has three levels of severity (no problems, some problems or moderate problems, and severe problems). severity levels are coded 1 if the response option is "no (I have) problems"; 2 if the response option is "some or moderate problems"; and 3 if the response option is "many problems".

  Baseline and up to four weeks

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

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

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

PLACEBO COMPARATOR

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

Device: Placebo Non-invasive Neuromodulation

Interventions

Non-invasive Neuromodulation DEVICE

The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.

Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation DEVICE

The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Placebo Non-invasive Neuromodulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

José Carlos del Castillo Rodríguez

Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38009, Spain

Location

Related Publications (4)

• Wilches C, Sulbaran JD, Fernandez JE, Gisbert JM, Bausili JM, Pelfort X. Fast-track recovery technique applied to primary total hip and knee replacement surgery. Analysis of costs and complications. Rev Esp Cir Ortop Traumatol. 2017 Mar-Apr;61(2):111-116. doi: 10.1016/j.recot.2016.10.002. Epub 2017 Jan 8. English, Spanish.

  PMID: 28073671 BACKGROUND

• Jansson MM, Harjumaa M, Puhto AP, Pikkarainen M. Patients' satisfaction and experiences during elective primary fast-track total hip and knee arthroplasty journey: A qualitative study. J Clin Nurs. 2020 Feb;29(3-4):567-582. doi: 10.1111/jocn.15121. Epub 2019 Dec 8.

  PMID: 31769559 BACKGROUND

• Mistry JB, Elmallah RD, Bhave A, Chughtai M, Cherian JJ, McGinn T, Harwin SF, Mont MA. Rehabilitative Guidelines after Total Knee Arthroplasty: A Review. J Knee Surg. 2016 Apr;29(3):201-17. doi: 10.1055/s-0036-1579670. Epub 2016 Mar 10.

  PMID: 26963074 BACKGROUND

• Davila Castrodad IM, Recai TM, Abraham MM, Etcheson JI, Mohamed NS, Edalatpour A, Delanois RE. Rehabilitation protocols following total knee arthroplasty: a review of study designs and outcome measures. Ann Transl Med. 2019 Oct;7(Suppl 7):S255. doi: 10.21037/atm.2019.08.15.

  PMID: 31728379 BACKGROUND

Study Officials

• José Carlos del Castillo Rodríguez, PhD

  Hospital San Juan de Dios Tenerife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: November 11, 2023
• Primary Completion: May 13, 2025
• Study Completion: July 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)