Knee ProsthesisNCT06134999
Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation
A study testing Non-invasive Neuromodulation in people with Knee Prosthesis, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Prosthesis
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
José Carlos del Castillo Rodríguez
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38009
About this study
Official title: Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial
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.
Read the 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.
- Conditions
- Knee Prosthesis
- Being tested
- Non-invasive Neuromodulation, Placebo Non-invasive Neuromodulation
- Keywords
- Total Knee Replacement, physical therapy modality, Electric Stimulation, Transcutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
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 NeuromodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. Receives: Device: Non-invasive Neuromodulation |
| Placebo Non-invasive Neuromodulation | Placebo comparator | Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7. Receives: Device: Placebo Non-invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline and up to four weeks
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.
Measured: Baseline and up to four weeks
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".
Measured: Baseline and up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Nov 2023
- Primary completion13 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- José Carlos del Castillo Rodríguez, PhD, Principal investigator, Hospital San Juan de Dios Tenerife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134999
- Sponsor's protocol ID
- PRONES
- Status last verified
- Mar 2025
- First submitted
- 11 Nov 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28073671Jansson 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.
PubMed 31769559Mistry 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.
PubMed 26963074Davila 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.
PubMed 31728379
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Patients With Knee Prostheses Treated With Noninvasive Neuromodulation. PRONES Trial
- ClinicalTrials.gov ID
- NCT06134999
- Acronym / sponsor ID
- PRONES
- Conditions
- Knee Prosthesis
- Keywords
- Total Knee Replacement, physical therapy modality, Electric Stimulation, Transcutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationNon-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
| Placebo Non-invasive Neuromodulation | Placebo comparator | Device: Placebo Non-invasive NeuromodulationIntervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationThe 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. | Device | Non-invasive Neuromodulation |
| Placebo Non-invasive NeuromodulationThe 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. | Device | Placebo Non-invasive Neuromodulation |
Primary outcome
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.
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 28073671Wilches 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.
- Results publication: PubMed 31769559Jansson 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.
- Results publication: PubMed 26963074Mistry 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.
- Results publication: PubMed 31728379Davila 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Carlos del Castillo Rodríguez, PhD principal investigator
Hospital San Juan de Dios Tenerife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Knee Prosthesis, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain assessed by VAS (time frame: Baseline and up to four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134999, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.