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

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

NCT ID: NCT06240377

Condition: Pain Cancer

Conditions: Keywords:
Cancer
Pain
Lower limb
TDCS
NMP

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)

Masking description: Simple Blind, Evaluator

Intervention:

Intervention type: Device
Intervention name: Transcranial direct current stimulation (tDCS)
Description: 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.
Arm group label: Epte Bipolar System 2.0 - Transcranial direct current stimulation (tDCS)

Intervention type: Device
Intervention name: Ultrasound-guided percutaneous neuromodulation (NMP)
Description: 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.
Arm group label: Epte Bipolar System 2.0 - Ultrasound-guided percutaneous neuromodulation (NMP)

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 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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 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. Exclusion Criteria: 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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Centro RED Tenerife

Address:
City: Santa Cruz De Tenerife
Zip: 38002
Country: Spain

Contact:
Last name: Eduardo Martin

Phone: 699553677
Email: edumartin@hotmail.es

Contact backup:
Last name: Eduardo Martín

Phone: 699553677
Email: edumartin@hotmail.es

Start date: June 1, 2024

Completion date: February 1, 2025

Lead sponsor:
Agency: Universidad Europea de Canarias
Agency class: Other

Source: Universidad Europea de Canarias

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06240377