Effectiveness of NMP and TDCS vs Pharmacological Treatment in Cancer Patients With Lower Limb Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-02-01

Brief Summary

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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

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Detailed Description

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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

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Pain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Simple Blind, Evaluator

Study Groups

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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 ACTIVE_COMPARATOR

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 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.

Epte Bipolar System 2.0 - 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)

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

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 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.

Interventions

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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.

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

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