Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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".
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 18 years of age
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Total knee replacement surgery at the Hospital San Juan de Dios de Tenerife.
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Be able to freely consent to take part in the study.
Exclusion Criteria:
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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.
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Patients with total knee prosthesis of more than 3 months of evolution.
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Patients with total knee prosthesis with complications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | José Carlos del Castillo Rodríguez | Santa Cruz De Tenerife | Spain | 38009 |
Sponsors and Collaborators
- University of Las Palmas de Gran Canaria
Investigators
- Principal Investigator: José Carlos del Castillo Rodríguez, PhD, Hospital San Juan de Dios Tenerife
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRONES