Pain CancerNCT06240390
Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain
A study testing Ultrasound-guided percutaneous neuromodulation (NMP) and pharmacological treatment by Opioids 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 Anterior Knee Pain relief in cancer patients? Participants will receive treatments of ultrasound-guided percutaneous neuromodulation and pharmacological treatment Researchers will compare… 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?
- Ultrasound-guided percutaneous neuromodulation (NMP) and pharmacological treatment by Opioids
- 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 May 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 the front of the knee.
- 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 Ultrasound-guided Percutaneous Neuromodulation Versus Pharmacological Treatment in Oncology Patients With Anterior Knee Pain
the goal of this clinical trial is to compare in cancer patients:
Is ultrasound-guided percutaneous neuromodulation useful for Anterior Knee Pain relief in cancer patients?
Participants will receive treatments of ultrasound-guided percutaneous neuromodulation and pharmacological treatment Researchers will compare ultrasound-guided percutaneous neuromodulation versus pharmacological treatment to see if Anterior Knee Pain is reduced
Read the detailed description
Unhealthy lifestyles, an aging population and increased life expectancy increase the likelihood of cancer. Knee pain is one of the most common symptoms that cause functional incapacity, which requires the search and improvement of its assessment, prevention and treatment tools.
Physiotherapists are currently using ultrasound-guided Percutaneous Neuromodulation clinically. It is an easy process to perform, non-invasive, safe and economical.
Traditional therapies have been and will continue to be useful. The decrease in manufacturing costs of assessment tools such as ultrasound and neuromodulator treatment in recent years has made the acquisition of these equipment as intervention tools economical. This is because they have been shown to be useful for improving function and reducing pain.
Opioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects.
In order to improve these symptoms, it is essential to have an objective knowledge of the changes produced by neuromodulation and to be able to measure the variation of pain experienced by patients.
It has been demonstrated in recent years that assessment tools such as ultrasound and myotonometer are very useful, safe and non-invasive procedures, both have been consolidated as assessment tools that can evaluate changes and analyze the contractile properties of soft tissue quickly and safely. There are abundant literature on this subject.
Therefore, researchers suggest conducting research that improves and provides new data on the efficacy and effectiveness of treatment of ultrasound-guided percutaneous neuromodulation.
- Conditions
- Pain Cancer
- Being tested
- Ultrasound-guided percutaneous neuromodulation (NMP), pharmacological treatment by Opioids
- Keywords
- Cancer, Pain, Anterior Knee Pain, 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.
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 transcranial direct current stimulation. 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
pharmacological treatment by OpioidsDrug
Also called pharmacological treatment - Opioids
Opioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects.
| Study group | Role | What they receive |
|---|---|---|
| Epte Bipolar System 2.0 - Ultrasound-guided percutaneous neuromodulation (NMP) | Experimental | 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) |
| pharmacological treatment by Opioids | Experimental | Opioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects.
Tramadol (Ultram®) Hydromorphone (Dilaudid®) Methadone (Dolophine®, Methadose®) Morphine (Apokyn®, Avinza®, Kadian®, MS-Contin®, among others) Oxycodone (OxyContin®, OxyIR®, Roxicodone®) Hydrocodone Oxymorphone (Opana®) Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others) Tapentadol (Nucynta®) Receives: Drug: pharmacological treatment by Opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS) Anterior Knee Pain changes
The Numerical Pain Rating Scale (NPRS) is a unique 11-point numeric scale that measures pain and instructs patients in clinical practice to choose a scale number from 0 to 10 with 0 for "no pain" and 10 for "worst pain possible." Its use is widely used in diseases of the knee or lower limbs, such as iliotibial girdle syndrome, sacroiliac joint dysfunction, plantar fasciitis or acute knee pain treated with microcurrents. It has also been used to treat shoulder pain in patients who have had surgery for breast cancer
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
The OKS (Oxford Knee Score) questionnaire for knee function.
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 (OA).
Measured: 12 weeks
The Lower Limb Functional Index (LLFI).
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
Borg's Rating Perceived Exertion (RPE) questionnaire for perceived fatigue.
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 believed to be a useful and cost-effective tool for monitoring exercise intensity.80 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
Pressure pain threshold
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. A pressure pain threshold (UDP) is usually used to measure this sensation. It is applied at the above point and measured in Kg/cm2.
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 May 2024
- 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, MsC, Principal investigator, Universidad Europea de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240390
- Sponsor's protocol ID
- 22109-2
- Status last verified
- Mar 2026
- First submitted
- 28 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 Ultrasound-guided Percutaneous Neuromodulation Versus Pharmacological Treatment in Oncology Patients With Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT06240390
- Acronym / sponsor ID
- 22109-2
- Conditions
- Pain Cancer
- Keywords
- Cancer, Pain, Anterior Knee Pain, 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 May 2024 (actual)
- 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 Anterior Knee Pain relief in cancer patients?
Participants will receive treatments of ultrasound-guided percutaneous neuromodulation and pharmacological treatment Researchers will compare ultrasound-guided percutaneous neuromodulation versus pharmacological treatment to see if Anterior Knee Pain is reduced
Detailed description
Unhealthy lifestyles, an aging population and increased life expectancy increase the likelihood of cancer. Knee pain is one of the most common symptoms that cause functional incapacity, which requires the search and improvement of its assessment, prevention and treatment tools.
Physiotherapists are currently using ultrasound-guided Percutaneous Neuromodulation clinically. It is an easy process to perform, non-invasive, safe and economical.
Traditional therapies have been and will continue to be useful. The decrease in manufacturing costs of assessment tools such as ultrasound and neuromodulator treatment in recent years has made the acquisition of these equipment as intervention tools economical. This is because they have been shown to be useful for improving function and reducing pain.
Opioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects.
In order to improve these symptoms, it is essential to have an objective knowledge of the changes produced by neuromodulation and to be able to measure the variation of pain experienced by patients.
It has been demonstrated in recent years that assessment tools such as ultrasound and myotonometer are very useful, safe and non-invasive procedures, both have been consolidated as assessment tools that can evaluate changes and analyze the contractile properties of soft tissue quickly and safely. There are abundant literature on this subject.
Therefore, researchers suggest conducting research that improves and provides new data on the efficacy and effectiveness of treatment of ultrasound-guided percutaneous neuromodulation.
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) | Experimental | 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) |
| pharmacological treatment by Opioids | Experimental | Drug: pharmacological treatment by OpioidsOpioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects. Tramadol (Ultram®) Hydromorphone (Dilaudid®) Methadone (Dolophine®, Methadose®) Morphine (Apokyn®, Avinza®, Kadian®, MS-Contin®, among others) Oxycodone (OxyContin®, OxyIR®, Roxicodone®) Hydrocodone Oxymorphone (Opana®) Fentanyl (Actiq®, Duragesic®, Fentora®, Lazanda®, Subsys®, and others) Tapentadol (Nucynta®) |
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 the front of the knee.
- 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 |
|---|---|---|
| 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 transcranial direct current stimulation. 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) |
| pharmacological treatment by OpioidsAlso: pharmacological treatment - OpioidsOpioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects. | Drug | pharmacological treatment by Opioids |
Primary outcome
Numerical Pain Rating Scale (NPRS) Anterior Knee Pain changes
Time frame: 12 weeks
The Numerical Pain Rating Scale (NPRS) is a unique 11-point numeric scale that measures pain and instructs patients in clinical practice to choose a scale number from 0 to 10 with 0 for "no pain" and 10 for "worst pain possible." Its use is widely used in diseases of the knee or lower limbs, such as iliotibial girdle syndrome, sacroiliac joint dysfunction, plantar fasciitis or acute knee pain treated with microcurrents. It has also been used to treat shoulder pain in patients who have had surgery for breast cancer
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
The OKS (Oxford Knee Score) questionnaire for knee function.
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 (OA).
The Lower Limb Functional Index (LLFI).
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
Borg's Rating Perceived Exertion (RPE) questionnaire for perceived fatigue.
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 believed to be a useful and cost-effective tool for monitoring exercise intensity.80 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
Pressure pain threshold
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. A pressure pain threshold (UDP) is usually used to measure this sensation. It is applied at the above point and measured in Kg/cm2.
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
Related trials for Pain Cancer
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
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, MsC 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 Ultrasound-guided percutaneous neuromodulation (NMP) and pharmacological treatment by Opioids 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) Anterior Knee Pain changes (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; AzTrials last refreshed its copy on 8 Nov 2026.