Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Prosthesis
• Intervention / Treatment: Device: Placebo Non-invasive Neuromodulation; Device: Non-invasive Neuromodulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José Carlos del Castillo Rodríguez, PhD; Phone Number: +34 922 23 55 12; Email: josecarlos.delcastillo@sjd.es
• Study Contact Backup: Name: Aníbal Báez-Suárez, PhD; Phone Number: +34 922 23 55 12; Email: anibal.baez@ulpgc.es

Study Locations

• Spain
  • Santa Cruz De Tenerife, Spain, 38009
    • Recruiting
    • José Carlos del Castillo Rodríguez
    • Sub-Investigator: Aníbal Báez-Suárez, PhD
    • Contact: José Carlos del Castillo Rodríguez, PhD; Phone Number: +34 922 23 55 12; Email: josecarlos.delcastillo@sjd.es
    • Sub-Investigator: Inmaculada Fierro Pera, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-invasive Neuromodulation; Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.	Device: Non-invasive Neuromodulation; 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.
Placebo Comparator: Placebo Non-invasive Neuromodulation; Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.	Device: Placebo Non-invasive Neuromodulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Las Palmas de Gran Canaria
• Investigators: Principal Investigator: José Carlos del Castillo Rodríguez, PhD, Hospital San Juan de Dios Tenerife

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): July 13, 2024
• Study Completion (Estimated): October 13, 2024

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Replacement; physical therapy modality; Electric Stimulation, Transcutaneous
• Other Study ID Numbers: PRONES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No