Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation

Not Applicable

Recruiting

• Conditions: Knee Prosthesis

• Registration Number: NCT06134999
• Lead Sponsor: University of Las Palmas de Gran Canaria

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.

Study Timeline

• Study Start: 2023-11-11
• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-05-13
• Study Completion: 2025-09-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in the quality of life test	Baseline and up to four weeks	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".
Change in Pain assessed by VAS	Baseline and up to four weeks	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".
Change in WOMAC questionnaire	Baseline and up to four weeks	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.

Trial Locations

Locations (1)

José Carlos del Castillo Rodríguez; 🇪🇸 Santa Cruz De Tenerife, Spain