Clinical trial NCT06134999: Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation
Official title: Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Prosthesis
Keywords: Total Knee Replacement
physical therapy modality
Electric Stimulation, Transcutaneous
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain assessed by VAS
timeFrame: Baseline and up to four weeks
measure: Change in WOMAC questionnaire
timeFrame: Baseline and up to four weeks
measure: Change in the quality of life test
timeFrame: Baseline and up to four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: José Carlos del Castillo Rodríguez
Study officials:
affiliation: Hospital San Juan de Dios Tenerife
name: José Carlos del Castillo Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.recot.2016.10.002. Epub 2017 Jan 8. English, Spanish.
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 2019 Dec 8.
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.
citation: 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.