Pain CancerNCT06240377
Effectiveness of NMP and TDCS vs Pharmacological Treatment in Cancer Patients With Lower Limb Pain
A study testing Transcranial direct current stimulation (tDCS) and Ultrasound-guided percutaneous neuromodulation (NMP) in people with Pain Cancer, run by Universidad Europea de Canarias at 1 site in Spain.
Trial summary
the goal of this clinical trial is to compare in cancer patients: Is ultrasound-guided percutaneous neuromodulation useful for lower limb pain relief in cancer patients? Is direct current transcranial stimulation useful for relieving lower limb pain in cancer patients? Participants will recive treatments of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Cancer
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Ultrasound-guided percutaneous neuromodulation (NMP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to 1 Feb 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The proposed inclusion criteria for the study are as follows:
- Age between 18 and 65.
- Pain in lower limbs
- Taking drug therapy for lower-extremity pain.
- Diagnosis of painful pathology in the anterior aspect of the knee secondary oncologic.
Who cannot join
- The exclusion criteria are:
- Traumatic history
- Have had any type of analgesic treatment in the last 4 weeks (clinical, physical or orthostatic)
- No need for drug treatment within the last 30 days of study initiation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro RED Tenerife
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38002
About this study
Official title: Study of the Effectiveness of Percutaneous Neuromodulation and Transcranial Direct Current Stimulation vs Pharmacological Treatment in Cancer Patients With Lower Limb Pain
the goal of this clinical trial is to compare in cancer patients:
Is ultrasound-guided percutaneous neuromodulation useful for lower limb pain relief in cancer patients?
Is direct current transcranial stimulation useful for relieving lower limb pain in cancer patients?
Participants will recive treatments of ultrasound-guided percutaneous neuromodulation and DC Transcranial Stimulation
Researchers will compare ultrasound-guided percutaneous neuromodulation and DC Transcranial Stimulation to see if pain in the lower extremities is reduced
Read the detailed description
Increasing life expectancy, aging populations, and unhealthy lifestyles increase the likelihood of cancer. Lower limb pain is one of the most common symptoms causing functional incapacitation that makes it necessary to seek and improve its assessment tools, prevention and treatment.
Ultrasound-guided Percutaneous Neuromodulation is a technique that is being applied clinically by physical therapists. It is an accessible, minimally invasive, safe and economical procedure to apply.
Transcranial direct current stimulation is a non-invasive neuromodulation technique that has been widely studied for the treatment of chronic pain. It is an accessible, non-invasive, safe and cost-effective procedure to apply.
Traditional therapies have been, are and will continue to be useful tools to consider. The reduction in the manufacturing costs of assessment and treatment tools in recent years makes it affordable to obtain these equipment as intervention tools, since its usefulness in improving functionality and reducing pain is proven.
Opioid analgesics are the main tool for the treatment of pain in cancer patients, but adverse effects or inadequate treatment make necessary the search for other therapeutic tools more economical, rapid and with less risk of addiction and / or side effects.
Objective knowledge of the changes produced by this treatment and the ability to quantify the variation in pain suffered by patients becomes urgent to take steps forward in improving these symptoms.
Ultrasound evaluation has been confirmed as a useful tool to assess changes in tissue in a non-invasive, fast and safe way. Its high reliability has been widely proven.
Myotonometry has been consolidated in the last decade as a non-invasive assessment tool able to analyze the contractile properties of soft tissue quickly and safely. Its reliability has been validated in multiple studies.
For this reason, researchers propose to conduct research that improves and provides new data on its effectiveness and efficacy in the treatment of ultrasound-guided Percutaneous Neuromodulation and transcranial direct current stimulation therapy (tDCS).
- Conditions
- Pain Cancer
- Being tested
- Transcranial direct current stimulation (tDCS), Ultrasound-guided percutaneous neuromodulation (NMP)
- Keywords
- Cancer, Pain, Lower limb, TDCS, NMP
- Medical subject headings
- Cancer Pain, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system.
It is a nationally manufactured device that meets all quality standards, being the perfect tool for the application of techniques such as tDCS. It is a versatile, compact, portable and easy to use equipment that has the ability to adapt the parameters to achieve any protocol established by scientific evidence to treat the various pathologies.
The EPTE® Bipolar System device has an CE Health Certificate.
Ultrasound-guided percutaneous neuromodulation (NMP)Device
EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system.
It is a nationally manufactured device that meets all quality standards, being the perfect tool for the application of techniques such as tDCS. It is a versatile, compact, portable and easy to use equipment that has the ability to adapt the parameters to achieve any protocol established by scientific evidence to treat the various pathologies.
The EPTE® Bipolar System device has an CE Health Certificate.
| Study group | Role | What they receive |
|---|---|---|
| Epte Bipolar System 2.0 - Ultrasound-guided percutaneous neuromodulation (NMP) | Active comparator | EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system. Ultrasound-guided percutaneous neuromodulation (NMP) Receives: Device: Ultrasound-guided percutaneous neuromodulation (NMP) |
| Epte Bipolar System 2.0 - Transcranial direct current stimulation (tDCS) | Active comparator | EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system. Transcranial direct current stimulation (tDCS) Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
Numerical Pain Rating Scale (NPRS) Lower limb pain changes
To mark its intensity patients should mark taking into account that 0 represents absence of pain and 10 the maximum pain imagined by the patient
Measured: 12 weeks
Victorian Institute of Sport Assessment-Patella (VISA-P)
The VISA-P questionnaire is used for assessing the severity of symptoms in individuals with patellar tendinopathy, the term pain refers to the specific area of the patellar tendon, to mark its intensity patients should mark taking into account that 0 represents absence of pain and 10 the maximum pain imagined by the patient. In the analysis of patellar tendon pathology has already been used in repeated articles
Measured: 12 weeks
OKS (Oxford Knee Score)
The Oxford Knee Score is a well-known tool for assessing quality of life in patients with Osteo Arthritis of the knee (OA). The OKS is a self-administered questionnaire that the patient can answer in face-to-face interviews or send by mail once completed. It contains 12 questions with 5 possible answers each aimed at evaluating the perception of the quality of life of the patient in the last four weeks. Each answer receives a score of 0 to 4, where 4 is the best possible result. After the sum, you get a total score ranging from 0 to 48, where 48 is the best possible result. The Spanish adaptation of the OKS questionnaire is a reliable tool to evaluate the perception of health-related quality of life of patients with knee osteoarthritis (KO)
Measured: 12 weeks
Lower Limb functional Index (LLFFI)
The questionnaire contains a number of phrases (25 in total) that patients use to describe problems on their legs. Evaluating only the last few days if a phrase describes you should check that box, you can also mark it partially and if not you should leave it blank. Finally, an LLFI score is obtained where the functional index of the lower extremities is determined. The LLFI consists of 25 items with three-point response options (Yes = 1 point), ("In part" or "half" 1/2 points) and (NO Points = 0). With a gross score range of 0 to 25 points. Takes approximately 2 minutes. The score is calculated by simply adding the answers together and multiplying them by four minus 100 to convert them into a percentage scale or maximum loss of function. The LLFI questionnaire in Spanish proved to be suitable for assessing the functionality of the lower limbs and viable for the evaluation of the condition and deterioration of the lower limbs in clinical and research settings
Measured: 12 weeks
RPE (Rating Perceived Exertion)
Borg created Borg's 15-point RPE scale. The modified RPE scale is 6 to 20 points. The level of physical exertion or perceived exertion is measured using the Borg 15-point RPE scale. A significant correlation was found between heart rate and Borg RPE of 15 points. In addition, this scale is thought to be a useful and economical tool for monitoring exercise intensity. Patients in clinical practice are instructed to choose a number from the scale and assess their total effort during endurance training. A score of six indicates lack of effort, or rest, and a score of twenty indicates maximum effort, or the most exhausting exercise
Measured: 12 weeks
Threshold of pressure pain
The intensity of pain can provide relevant information, until now the measurement of pain was carried out subjectively for this reason there are efforts to develop devices to measure the intensity of painful stimuli objectively. Severity of pain also affects the patient's treatment strategy and goals because pain can cause incapacitation. Thus, several researchers have focused their efforts on creating pain-measuring devices called algometers. To measure this sensation, a pressure pain threshold (UDP)81 is usually used. It is applied at the above point and measured in N.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Why it stopped: Study not initiated prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain CancerStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Luis Martín Javier, Universidad Europea de Canarias
- Investigators
- Eduardo Martín, Principal investigator, Universidad Europea de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240377
- Sponsor's protocol ID
- 22109-1
- Status last verified
- Mar 2026
- First submitted
- 26 Dec 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Percutaneous Neuromodulation and Transcranial Direct Current Stimulation vs Pharmacological Treatment in Cancer Patients With Lower Limb Pain
- ClinicalTrials.gov ID
- NCT06240377
- Acronym / sponsor ID
- 22109-1
- Conditions
- Pain Cancer
- Keywords
- Cancer, Pain, Lower limb, TDCS, NMP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad Europea de CanariasUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 5 Feb 2024 (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.
the goal of this clinical trial is to compare in cancer patients:
Is ultrasound-guided percutaneous neuromodulation useful for lower limb pain relief in cancer patients?
Is direct current transcranial stimulation useful for relieving lower limb pain in cancer patients?
Participants will recive treatments of ultrasound-guided percutaneous neuromodulation and DC Transcranial Stimulation
Researchers will compare ultrasound-guided percutaneous neuromodulation and DC Transcranial Stimulation to see if pain in the lower extremities is reduced
Detailed description
Increasing life expectancy, aging populations, and unhealthy lifestyles increase the likelihood of cancer. Lower limb pain is one of the most common symptoms causing functional incapacitation that makes it necessary to seek and improve its assessment tools, prevention and treatment.
Ultrasound-guided Percutaneous Neuromodulation is a technique that is being applied clinically by physical therapists. It is an accessible, minimally invasive, safe and economical procedure to apply.
Transcranial direct current stimulation is a non-invasive neuromodulation technique that has been widely studied for the treatment of chronic pain. It is an accessible, non-invasive, safe and cost-effective procedure to apply.
Traditional therapies have been, are and will continue to be useful tools to consider. The reduction in the manufacturing costs of assessment and treatment tools in recent years makes it affordable to obtain these equipment as intervention tools, since its usefulness in improving functionality and reducing pain is proven.
Opioid analgesics are the main tool for the treatment of pain in cancer patients, but adverse effects or inadequate treatment make necessary the search for other therapeutic tools more economical, rapid and with less risk of addiction and / or side effects.
Objective knowledge of the changes produced by this treatment and the ability to quantify the variation in pain suffered by patients becomes urgent to take steps forward in improving these symptoms.
Ultrasound evaluation has been confirmed as a useful tool to assess changes in tissue in a non-invasive, fast and safe way. Its high reliability has been widely proven.
Myotonometry has been consolidated in the last decade as a non-invasive assessment tool able to analyze the contractile properties of soft tissue quickly and safely. Its reliability has been validated in multiple studies.
For this reason, researchers propose to conduct research that improves and provides new data on its effectiveness and efficacy in the treatment of ultrasound-guided Percutaneous Neuromodulation and transcranial direct current stimulation therapy (tDCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epte Bipolar System 2.0 - Ultrasound-guided percutaneous neuromodulation (NMP) | Active comparator | Device: Ultrasound-guided percutaneous neuromodulation (NMP)EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system. Ultrasound-guided percutaneous neuromodulation (NMP) |
| Epte Bipolar System 2.0 - Transcranial direct current stimulation (tDCS) | Active comparator | Device: Transcranial direct current stimulation (tDCS)EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system. Transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65.
- Pain in lower limbs
- Taking drug therapy for lower-extremity pain.
- Diagnosis of painful pathology in the anterior aspect of the knee secondary oncologic.
Key exclusion criteria (4 listed)
- Traumatic history
- Have had any type of analgesic treatment in the last 4 weeks (clinical, physical or orthostatic)
- No need for drug treatment within the last 30 days of study initiation.
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system. It is a nationally manufactured device that meets all quality standards, being the perfect tool for the application of techniques such as tDCS. It is a versatile, compact, portable and easy to use equipment that has the ability to adapt the parameters to achieve any protocol established by scientific evidence to treat the various pathologies. The EPTE® Bipolar System device has an CE Health Certificate. | Device | Epte Bipolar System 2.0 - Transcranial direct current stimulation (tDCS) |
| Ultrasound-guided percutaneous neuromodulation (NMP)EPTE Bipolar System is a medical device for health professionals that combines several techniques that extend the therapeutic variety of electrostimulation, for the treatment of different pathologies of the musculoskeletal system and peripheral and central nervous system. It is a nationally manufactured device that meets all quality standards, being the perfect tool for the application of techniques such as tDCS. It is a versatile, compact, portable and easy to use equipment that has the ability to adapt the parameters to achieve any protocol established by scientific evidence to treat the various pathologies. The EPTE® Bipolar System device has an CE Health Certificate. | Device | Epte Bipolar System 2.0 - Ultrasound-guided percutaneous neuromodulation (NMP) |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: 12 weeks
Numerical Pain Rating Scale (NPRS) Lower limb pain changes To mark its intensity patients should mark taking into account that 0 represents absence of pain and 10 the maximum pain imagined by the patient
Victorian Institute of Sport Assessment-Patella (VISA-P)
Time frame: 12 weeks
The VISA-P questionnaire is used for assessing the severity of symptoms in individuals with patellar tendinopathy, the term pain refers to the specific area of the patellar tendon, to mark its intensity patients should mark taking into account that 0 represents absence of pain and 10 the maximum pain imagined by the patient. In the analysis of patellar tendon pathology has already been used in repeated articles
OKS (Oxford Knee Score)
Time frame: 12 weeks
The Oxford Knee Score is a well-known tool for assessing quality of life in patients with Osteo Arthritis of the knee (OA). The OKS is a self-administered questionnaire that the patient can answer in face-to-face interviews or send by mail once completed. It contains 12 questions with 5 possible answers each aimed at evaluating the perception of the quality of life of the patient in the last four weeks. Each answer receives a score of 0 to 4, where 4 is the best possible result. After the sum, you get a total score ranging from 0 to 48, where 48 is the best possible result. The Spanish adaptation of the OKS questionnaire is a reliable tool to evaluate the perception of health-related quality of life of patients with knee osteoarthritis (KO)
Lower Limb functional Index (LLFFI)
Time frame: 12 weeks
The questionnaire contains a number of phrases (25 in total) that patients use to describe problems on their legs. Evaluating only the last few days if a phrase describes you should check that box, you can also mark it partially and if not you should leave it blank. Finally, an LLFI score is obtained where the functional index of the lower extremities is determined. The LLFI consists of 25 items with three-point response options (Yes = 1 point), ("In part" or "half" 1/2 points) and (NO Points = 0). With a gross score range of 0 to 25 points. Takes approximately 2 minutes. The score is calculated by simply adding the answers together and multiplying them by four minus 100 to convert them into a percentage scale or maximum loss of function. The LLFI questionnaire in Spanish proved to be suitable for assessing the functionality of the lower limbs and viable for the evaluation of the condition and deterioration of the lower limbs in clinical and research settings
RPE (Rating Perceived Exertion)
Time frame: 12 weeks
Borg created Borg's 15-point RPE scale. The modified RPE scale is 6 to 20 points. The level of physical exertion or perceived exertion is measured using the Borg 15-point RPE scale. A significant correlation was found between heart rate and Borg RPE of 15 points. In addition, this scale is thought to be a useful and economical tool for monitoring exercise intensity. Patients in clinical practice are instructed to choose a number from the scale and assess their total effort during endurance training. A score of six indicates lack of effort, or rest, and a score of twenty indicates maximum effort, or the most exhausting exercise
Threshold of pressure pain
Time frame: 12 weeks
The intensity of pain can provide relevant information, until now the measurement of pain was carried out subjectively for this reason there are efforts to develop devices to measure the intensity of painful stimuli objectively. Severity of pain also affects the patient's treatment strategy and goals because pain can cause incapacitation. Thus, several researchers have focused their efforts on creating pain-measuring devices called algometers. To measure this sensation, a pressure pain threshold (UDP)81 is usually used. It is applied at the above point and measured in N.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- 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.
Eduardo Martín principal investigator
Universidad Europea de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and Ultrasound-guided percutaneous neuromodulation (NMP) in people with Pain Cancer, run by Universidad Europea de Canarias 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 Mar 2026. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Numerical Pain Rating Scale (NPRS) (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.