Evidence map›Paper›PMID 39133680›Full record

ArticlePloS one2024

Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study.

Maarten Moens, Cleo Lina Crunelle, Koen Putman, Elke Wuyts, Frenn Bultinck, Hubert Van Puyenbroeck, PIANISSIMO consortium, Lisa Goudman

2 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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.

NCT05861609 narecruitingnot on this map

Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.

TypeinterventionalSponsorMoens MaartenRan2023 to 2026Enrolled195ConditionsPersistent Spinal Pain Syndrome Type 2, Spinal Cord StimulationArmsUsual care, Standardized pain medication tapering, Personalized pain medication tapering
NCT07413731 recruitingnot on this mapstarted 2025, after this paper: background citation

Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods

TypeobservationalSponsorBrai²nRan2025 to 2027Enrolled50ConditionsPersistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine, Spinal Cord Sensitivity to Neurostimulation, Neurophysiological Sensitivity to Spinal Cord StimulationArmsSpinal Cord Stimulation with Evoke Closed-Loop System
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.

Maarten MoensSTIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium.
Cleo Lina CrunelleCenter for Neurosciences (C4N), Vrije Universiteit Brussel, Brussels, Belgium.
Koen PutmanFaculty of Medicine and Pharmacy, Department of Public Health (GEWE), Interuniversity Centre for Health Economics Research (I-CHER), Vrije Universiteit Brussel, Brussels, Belgium.
Elke WuytsSTIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium.ORCID https://orcid.org/0000-0001-7322-4628
Frenn BultinckFaculty of Medicine and Pharmacy, Department of Public Health (GEWE), Interuniversity Centre for Health Economics Research (I-CHER), Vrije Universiteit Brussel, Brussels, Belgium.ORCID https://orcid.org/0000-0003-4176-6515
Hubert Van PuyenbroeckSTIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium.
PIANISSIMO consortium
Lisa GoudmanSTIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium.ORCID https://orcid.org/0000-0002-2271-9855

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSpinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. METHODS AND

designA three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. DISCUSSION: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients.

trial registrationClinicalTrials.gov NCT05861609. Registered on May 17, 2023.

Indexed as

Spinal Cord StimulationAdultAnalgesicsChronic PainDrug TaperingFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPain ManagementPain MeasurementQuality of LifeRandomized Controlled Trials as TopicAnalgesics

Identifiers

PMID39133680
PMCPMC11318931

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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 Socratic graph.