Evidence map›Paper›PMID 35705354›Full record

ArticleBMJ open2022

High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial.

Divya Bharatkumar Adhia, Ramakrishnan Mani, John N J Reynolds, Sven Vanneste, Dirk De Ridder

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
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

5 authors at 2 institutions in 2 countries.

Divya Bharatkumar AdhiaDepartment of Surgical Sciences, and Pain@Otago Research Theme, University of Otago - Dunedin Campus, Dunedin, New Zealand divya.adhia@otago.ac.nz.ORCID 0000-0002-2505-4916
Ramakrishnan ManiCentre for Health, Activity and Rehabilitation Research, School of Physiotherapy, and Pain@Otago Research Theme, University of Otago - Dunedin Campus, Dunedin, New Zealand.
John N J ReynoldsDepartment of Anatomy and the Brain Health Research Centre, University of Otago - Dunedin Campus, Dunedin, New Zealand.
Sven VannesteSchool of Psychology, Global Brain Health Institute, Institute of Neuroscience, Trinity College Dublin, Dublin, Ireland.
Dirk De RidderDepartment of Surgical Sciences, and Pain@Otago Research Theme, University of Otago - Dunedin Campus, Dunedin, New Zealand.
University of Otago · NZTrinity College Dublin · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic low back pain (CLBP) is a common disabling health condition. Current treatments demonstrate modest effects, warranting newer therapies. Brain imaging demonstrates altered electrical activities in cortical areas responsible for pain modulation, emotional and sensory components of pain experience. Treatments targeting to change electrical activities of these key brain regions may produce clinical benefits. This pilot study aims to (1) evaluate feasibility, safety and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, (2) explore the trend of effect of HD-tIPNS on pain and function, and (3) derive treatment estimates to support sample size calculation for a fully powered trial should trends of effectiveness be present. METHODS AND ANALYSIS: A pilot, triple-blinded randomised two-arm placebo-controlled parallel trial. Participants (n=40) with CLBP will be randomised to either sham stimulation or HD-tIPNS (targeting somatosensory cortex and dorsal and pregenual anterior cingulate cortex). Primary outcomes include feasibility and safety measures, and clinical outcomes of pain (Brief Pain Inventory) and disability (Roland-Morris disability questionnaire). Secondary measures include clinical, psychological, quantitative sensory testing and electroencephalography collected at baseline, immediately postintervention, and at 1-week, 1-month and 3 months postintervention. All data will be analysed descriptively. A nested qualitative study will assess participants perceptions about acceptability of intervention and analysed thematically. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Health and Disability Ethics Committee (Ref:20/NTB/67). Findings will be reported to regulatory and funding bodies, presented at conferences, and published in a scientific journal. TRIAL REGISTRATION NUMBER: ACTRN12620000505909p.

Indexed as

Chronic PainLow Back PainFeasibility StudiesHumansPain MeasurementPilot ProjectsQualitative ResearchRandomized Controlled Trials as TopicBack painNeurological painNeurologyPain managementSpine

Identifiers

PMID35705354
PMCPMC9204463
OpenAlexW4282968247

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.