Clinical trial NCT06240377: Effectiveness of NMP and TDCS vs Pharmacological Treatment in Cancer Patients With Lower Limb Pain
Official title: Study of the Effectiveness of Percutaneous Neuromodulation and Transcranial Direct Current Stimulation vs Pharmacological Treatment in Cancer Patients With Lower Limb Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Cancer
Keywords: Cancer
Pain
Lower limb
TDCS
NMP
Lead sponsor: Universidad Europea de Canarias
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 12 weeks
measure: Victorian Institute of Sport Assessment-Patella (VISA-P)
timeFrame: 12 weeks
measure: OKS (Oxford Knee Score)
timeFrame: 12 weeks
measure: Lower Limb functional Index (LLFFI)
timeFrame: 12 weeks
measure: RPE (Rating Perceived Exertion)
timeFrame: 12 weeks
measure: Threshold of pressure pain
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Centro RED Tenerife
Study officials:
affiliation: Universidad Europea de Canarias
name: Eduardo Martín
role: PRINCIPAL_INVESTIGATOR
References: