Evidence map›Paper›PMID 29234136›Full record

Trial reportSpinal cord2018

Study adherence in a tDCS longitudinal clinical trial with people with spinal cord injury.

Sandra Carvalho, Jorge Leite, Felipe Jones, Leslie R Morse, Ross Zafonte, Felipe Fregni

Open access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Spinal cord, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. 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

6 authors at 2 institutions in 2 countries.

Sandra CarvalhoSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.
Jorge LeiteSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0323-9012
Felipe JonesSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.
Leslie R MorseSpaulding-Harvard Spinal Cord Injury System, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
Ross ZafonteSpaulding-Harvard Spinal Cord Injury System, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
Felipe FregniSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA. fregni.felipe@mgh.harvard.edu.
Harvard University · USCraig Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designSecondary analysis of a clinical trial.

objectivesTo analyze adherence to 1-year transcranial Direct Current Stimulation (tDCS) clinical trial in people with chronic pain due to spinal cord injury (SCI). We also explore the association between dropout and several baseline variables such as age, depression levels, pain severity, number of days with pain in the last 7 days, walking ability, sleep, work, relationship with others, and enjoyment with life.

settingBoston, USA.

methodsForty-six participants were enrolled in this trial, and 33 participants were randomized to receive either active or sham tDCS.

resultsUsing the full intention-to-treat (ITT) criteria, only 8 participants (24%) finished the study. The median time to dropout was seven (IQR:6,19) sessions (i.e., immediately after the first follow-up), regardless of the type of stimulation that participants received (active vs. sham tDCS) (χ2 = 0.025, p = 0.875). An exploratory analysis suggested that only the number of days with pain in the last 7 days was moderately associated with dropout, with people experiencing less pain being more prone to dropout from the study.

conclusionsDespite all the measures to improve study adherence (such as providing parking, flexibility to schedule sessions, follow-up with participants by phone), it seems that long follow-up periods may increase the likelihood of dropout. Given the need to understand long-term effects of interventions, longitudinal trials need to consider alternative designs or methods of treatment (for instance home treatment or home assessment) to decrease attrition rate.

Indexed as

Patient DropoutsTranscranial Direct Current StimulationAge FactorsChronic PainDepressionDisability EvaluationEmploymentFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementPersonal SatisfactionSleepSpinal Cord Injuries

Identifiers

PMID29234136
OpenAlexW2775082551

What OpenQuestion holds

Textmetadata
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.