Evidence map›Paper›PMID 36471349›Full record

ArticleTrials2022

Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study.

Maarten Moens, Lisa Goudman, Dominique Van de Velde, Lode Godderis, Koen Putman, Jonas Callens, Olivia Lavreysen, Dries Ceulemans, Laurence Leysen, OPERA consortium and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05269212 (Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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.

NCT05269212 narecruitingnot on this map

Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II: a Randomized Controlled Trial.

TypeinterventionalSponsorMoens MaartenRan2022 to 2027Enrolled112ConditionsFailed Back Surgery Syndrome, Spinal Cord StimulationArmsUsual Care trajectory, A biopsychosocial rehabilitation program
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Article
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  7. Article
  8. Personalized Approaches to Spine Surgery.International journal of spine surgery · 2024
    Article
  9. Review
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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

11 authors.

Maarten MoensSTIMULUS research group, Vrije Universiteit Brussel, Laarbeeklaan 103, Jette, 1090, Belgium.
Lisa GoudmanSTIMULUS research group, Vrije Universiteit Brussel, Laarbeeklaan 103, Jette, 1090, Belgium. lisa.goudman@vub.be.ORCID http://orcid.org/0000-0002-2271-9855
Dominique Van de VeldeFaculty of Medicine and Healthcare Sciences, Department of Rehabilitation Sciences, Occupational Therapy Program, Ghent University, Ghent, 9000, Belgium.
Lode GodderisCentre for Environment and Health, Department of Public Health and Primary Care, KU Leuven (University of Leuven), Leuven, 3000, Belgium.
Koen PutmanInteruniversity Centre for Health Economics Research (I-CHER), Department of Public Health (GEWE), Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 103, Jette, 1090, Belgium.
Jonas CallensSTIMULUS research group, Vrije Universiteit Brussel, Laarbeeklaan 103, Jette, 1090, Belgium.
Olivia LavreysenCentre for Environment and Health, Department of Public Health and Primary Care, KU Leuven (University of Leuven), Leuven, 3000, Belgium.
Dries CeulemansFaculty of Medicine and Healthcare Sciences, Department of Rehabilitation Sciences, Occupational Therapy Program, Ghent University, Ghent, 9000, Belgium.
Laurence LeysenSTIMULUS research group, Vrije Universiteit Brussel, Laarbeeklaan 103, Jette, 1090, Belgium.
OPERA consortium
Ann De SmedtSTIMULUS research group, Vrije Universiteit Brussel, Laarbeeklaan 103, Jette, 1090, Belgium.

Funding

Fonds Wetenschappelijk Onderzoek T000821N
6 · The paper itself

Abstract

backgroundFor patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.

methodsA two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure. DISCUSSION: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.

trial registrationClinicalTrials.gov NCT05269212. Registered on 7 March 2022.

Indexed as

Spinal Cord StimulationHumansMulticenter Studies as TopicPainPain MeasurementQuality of LifeRandomized Controlled Trials as TopicReturn to WorkTreatment OutcomeFailed back surgery syndromeNeuromodulationPersonalised medicineRandomised controlled trialRehabilitation

Identifiers

PMID36471349
PMCPMC9721015

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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 OpenQuestion graph.