Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Knee Prosthesis
- Sponsor
- University of Las Palmas de Gran Canaria
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in the quality of life test
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Aníbal Báez Suárez
Clinical Professor
University of Las Palmas de Gran Canaria
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.
Outcomes
Primary Outcomes
Change in the quality of life test
Time Frame: 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
Time Frame: 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
Time Frame: 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.