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

NCT06240377 | Withdrawn

• 1 other identifier: 22109-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Pain Cancer

Keywords

Cancer; Pain; Lower limb; TDCS; NMP

Outcome Measures

Primary Outcomes (6)

• Numerical Pain Rating Scale (NPRS)

  Numerical Pain Rating Scale (NPRS) Lower limb pain changes To mark its intensity patients should mark taking into account that 0 represents absence of pain and 10 the maximum pain imagined by the patient

  12 weeks

• Victorian Institute of Sport Assessment-Patella (VISA-P)

  The VISA-P questionnaire is used for assessing the severity of symptoms in individuals with patellar tendinopathy, the term pain refers to the specific area of the patellar tendon, to mark its intensity patients should mark taking into account that 0 represents absence of pain and 10 the maximum pain imagined by the patient. In the analysis of patellar tendon pathology has already been used in repeated articles

  12 weeks

• OKS (Oxford Knee Score)

  The Oxford Knee Score is a well-known tool for assessing quality of life in patients with Osteo Arthritis of the knee (OA). The OKS is a self-administered questionnaire that the patient can answer in face-to-face interviews or send by mail once completed. It contains 12 questions with 5 possible answers each aimed at evaluating the perception of the quality of life of the patient in the last four weeks. Each answer receives a score of 0 to 4, where 4 is the best possible result. After the sum, you get a total score ranging from 0 to 48, where 48 is the best possible result. The Spanish adaptation of the OKS questionnaire is a reliable tool to evaluate the perception of health-related quality of life of patients with knee osteoarthritis (KO)

  12 weeks

• Lower Limb functional Index (LLFFI)

  The questionnaire contains a number of phrases (25 in total) that patients use to describe problems on their legs. Evaluating only the last few days if a phrase describes you should check that box, you can also mark it partially and if not you should leave it blank. Finally, an LLFI score is obtained where the functional index of the lower extremities is determined. The LLFI consists of 25 items with three-point response options (Yes = 1 point), ("In part" or "half" 1/2 points) and (NO Points = 0). With a gross score range of 0 to 25 points. Takes approximately 2 minutes. The score is calculated by simply adding the answers together and multiplying them by four minus 100 to convert them into a percentage scale or maximum loss of function. The LLFI questionnaire in Spanish proved to be suitable for assessing the functionality of the lower limbs and viable for the evaluation of the condition and deterioration of the lower limbs in clinical and research settings

  12 weeks

• RPE (Rating Perceived Exertion)

  Borg created Borg's 15-point RPE scale. The modified RPE scale is 6 to 20 points. The level of physical exertion or perceived exertion is measured using the Borg 15-point RPE scale. A significant correlation was found between heart rate and Borg RPE of 15 points. In addition, this scale is thought to be a useful and economical tool for monitoring exercise intensity. Patients in clinical practice are instructed to choose a number from the scale and assess their total effort during endurance training. A score of six indicates lack of effort, or rest, and a score of twenty indicates maximum effort, or the most exhausting exercise

  12 weeks

• Threshold of pressure pain

  The intensity of pain can provide relevant information, until now the measurement of pain was carried out subjectively for this reason there are efforts to develop devices to measure the intensity of painful stimuli objectively. Severity of pain also affects the patient's treatment strategy and goals because pain can cause incapacitation. Thus, several researchers have focused their efforts on creating pain-measuring devices called algometers. To measure this sensation, a pressure pain threshold (UDP)81 is usually used. It is applied at the above point and measured in N.

  12 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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)

Device: Ultrasound-guided percutaneous neuromodulation (NMP)

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

ACTIVE COMPARATOR

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)

Device: Transcranial direct current stimulation (tDCS)

Interventions

Ultrasound-guided percutaneous neuromodulation (NMP) 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 - Ultrasound-guided percutaneous neuromodulation (NMP)

Transcranial direct current stimulation (tDCS) 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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Canarias: lead

Study Sites (1)

Centro RED Tenerife

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38002, Spain

Location

MeSH Terms

Conditions

Cancer Pain; Neoplasms; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Eduardo Martín

  Universidad Europea de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Simple Blind, Evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science Professor Eduardo Martín

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: February 5, 2024
• Study Start: June 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: February 1, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)