Evidence map›Paper›PMID 41184916›Full record

ArticleBMC cancer2025

PAINLESS: protocol for a triple-blinded randomized sham-controlled multicenter trial of home-based transcranial electrical stimulation for pain management in patients with cancer.

Andrea Antal, Perianen Ramasawmy, Lara Rubal-Otero, Ivan Chakalov, Margarita Álvarez Rodríguez, Alexander Hunold, Klaus Schellhorn, María Teresa Carrillo-de-la-Peña

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Andrea AntalNon-Invasive Brain Stimulation Lab, Department of Neurology, University Medical Center Göttingen, Georg-August University, Robert Koch-Straße 40, Göttingen, 37075, Germany.
Perianen RamasawmyNon-Invasive Brain Stimulation Lab, Department of Neurology, University Medical Center Göttingen, Georg-August University, Robert Koch-Straße 40, Göttingen, 37075, Germany. perianen.ramasawmy@med.uni-goettingen.de.
Lara Rubal-OteroBrain and Pain Lab, Department of Clinical Psychology and Psychobiology, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.
Ivan ChakalovNon-Invasive Brain Stimulation Lab, Department of Neurology, University Medical Center Göttingen, Georg-August University, Robert Koch-Straße 40, Göttingen, 37075, Germany.
Margarita Álvarez RodríguezFundación Pública Galega de Investigación Biomédica Galicia Sur, Vigo, Spain.
Alexander HunoldNeuroConn GmbH, Ilmenau, Germany.
Klaus SchellhornNeuroConn GmbH, Ilmenau, Germany.
María Teresa Carrillo-de-la-PeñaBrain and Pain Lab, Department of Clinical Psychology and Psychobiology, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPain is a common debilitating symptom in cancer patients and its management remains a challenge. Among the non-pharmacological analgesic treatment options, low intensity transcranial electrical stimulation (tES) represents a new unique analgesic modality. However, the evidence of tES effectiveness for cancer pain is limited, while the mechanisms of pain relief due to tES are still poorly understood. We propose to test the efficacy of repetitive transcranial direct current stimulation (tDCS) and alternating current stimulation (tACS) in cancer pain patients, and attempt to understand their mechanisms using electroencephalography (EEG) and quantitative sensory testing (QST) measures.

methodsThis article describes the protocol of a multicenter, sham-controlled, parallel-arm, triple-blinded randomized clinical trial assessing home-based tDCS and tACS in the treatment of cancer patients with persistent pain. 450 patients between 18 and 75 years old will be enrolled in this study. Treatment consists of 15 consecutive daily sessions of either anodal tDCS at 2 mA targeting the primary motor cortex or 10 Hz tACS targeting the dorsolateral prefrontal cortex. Following randomization (2:2:1 ratio), 180 patients will receive active tDCS, 180 patients active tACS, and 90 patients sham stimulation. The primary outcome is self-reported pain intensity on a numerical rating scale (NRS) assessed daily (15 days pre-treatment, 15 days during treatment and 15 days post-treatment). The secondary endpoints are medication intake, other cancer-associated symptoms and quality of life. We will also analyze psychophysical and neurophysiological correlates of ascending and descending pain processing using QST and EEG paradigms. Besides the NRS, which will be reported daily, assessments will be conducted at baseline (T0) and at three time points post-intervention (T1, T2, and T3). DISCUSSION: Positive findings of the study will indicate the therapeutic benefit of tES in patients with cancer-related pain. Group differences in mechanistic measures would yield potential biomarkers for tDCS- and tACS-induced analgesia, which could be used for personalizing and optimizing the intervention. In addition, changes in EEG or QST could provide insights into the mechanisms underlying the tES effects.

trial registrationThe study was registered at the German Clinical Trials Register under the identification number DRKS00031070.

Indexed as

Cancer PainNeoplasmsPain ManagementTranscranial Direct Current StimulationAdolescentAdultAgedElectroencephalographyFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPain MeasurementRandomized Controlled Trials as TopicTreatment OutcomeCancer painElectroencephalographyNon-invasive brain stimulationQuantitative sensory testingTranscranial alternating current stimulationTranscranial direct current stimulation

Identifiers

PMID41184916
PMCPMC12581329

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.