Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain

NCT ID: NCT06240390

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-01

Brief 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 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.

Conditions

Pain Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Epte Bipolar System 2.0 - 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)

Group Type: EXPERIMENTAL

Ultrasound-guided percutaneous neuromodulation (NMP)

Intervention Type: 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 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.

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®)

Group Type: EXPERIMENTAL

pharmacological treatment by Opioids

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DEVICE

pharmacological treatment by 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.

Intervention Type: DRUG

Other Intervention Names

pharmacological treatment - Opioids

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Canarias

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Luis Martín Javier

Master of Science Professor Eduardo Martín

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo Martín, MsC

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Canarias

Locations

Centro RED Tenerife

Santa Cruz de Tenerife, , Spain

Countries

Spain

Central Contacts

Eduardo Martín, MsC

Role: CONTACT

edumartin@hotmail.es

699553677

Eduardo Luis Martín Javier, MsC

Role: CONTACT

eduardoluis.martin@universidadueuropea.es

699553677

Other Identifiers

22109-2

Identifier Type: -

Identifier Source: org_study_id