Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

Knee Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134999
• Other study ID #: PRONES
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: October 13, 2024

Study information

• Verified date: March 2024
• Source: University of Las Palmas de Gran Canaria
• Contact: José Carlos del Castillo Rodríguez, PhD
• Phone: +34 922 23 55 12
• Email: josecarlos.delcastillo[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 13, 2024
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Prosthesis

Intervention

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 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.

Locations

Country	Name	City	State
Spain	José Carlos del Castillo Rodríguez	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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: 10.21 — View Citation

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 2 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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