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

Universidad Europea de Canarias

Status: Not yet enrolling

Conditions: Pain Cancer

Treatments: Device: Transcranial direct current stimulation (tDCS); Device: Ultrasound-guided percutaneous neuromodulation (NMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06240377

22109-1

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups

Epte Bipolar System 2.0 - Ultrasound-guided percutaneous neuromodulation (NMP)

Active Comparator group

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. Ultrasound-guided percutaneous neuromodulation (NMP)

Treatment:

Device: Ultrasound-guided percutaneous neuromodulation (NMP)

Epte Bipolar System 2.0 - Transcranial direct current stimulation (tDCS)

Active Comparator group

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. Transcranial direct current stimulation (tDCS)

Treatment:

Device: Transcranial direct current stimulation (tDCS)