Evidence map›Paper›PMID 36494768›Full record

ArticlePilot and feasibility studies2022

The PerPAIN trial: a pilot randomized controlled trial of personalized treatment allocation for chronic musculoskeletal pain-a protocol.

E Beiner, D Baumeister, D Buhai, M Löffler, A Löffler, A Schick, L Ader, W Eich, A Sirazitdinov, C Malone and 7 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

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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

17 authors at 6 institutions in 2 countries.

E BeinerDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Germany.
D BaumeisterDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Germany.
D BuhaiDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Germany.
M LöfflerInstitute of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
A LöfflerInstitute of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
A SchickDepartment of Public Mental Health; Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
L AderDepartment of Public Mental Health; Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
W EichDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Germany.
A SirazitdinovExperimental Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
C MaloneInstitute of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
M HoppInterdisciplinary Center for Clinical Trials, Johannes Gutenberg University Medical Center Mainz, Mainz, Germany.
C RuckesInterdisciplinary Center for Clinical Trials, Johannes Gutenberg University Medical Center Mainz, Mainz, Germany.
J HesserExperimental Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
U ReininghausDepartment of Public Mental Health; Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
H FlorInstitute of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
J TesarzDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Heidelberg, Germany. jonas.tesarz@med.uni-heidelberg.de.
PerPAIN consortium
Heidelberg University · DEUniversity Hospital Heidelberg · DECentral Institute of Mental Health · DEJohannes Gutenberg University Mainz · DEUniversitätsklinik Balgrist · CHUniversity Medical Center of the Johannes Gutenberg University Mainz · DE

Funding

BMBF 01EC1904A
6 · The paper itself

Abstract

backgroundThe therapy of chronic musculoskeletal pain (CMSP) is complex and the treatment results are often insufficient despite numerous therapeutic options. While individual patients respond very well to specific interventions, other patients show no improvement. Personalized treatment assignment offers a promising approach to improve response rates; however, there are no validated cross-disease allocation algorithms available for the treatment of chronic pain in validated personalized pain interventions. This trial aims to test the feasibility and safety of a personalized pain psychotherapy allocation with three different treatment modules and estimate initial signals of efficacy and utility of such an approach compared to non-personalized allocation.

methodsThis is a randomized, controlled assessor-blinded pilot trial with a multifactorial parallel arm design. CMSP patients (n = 105) will be randomly assigned 1:1 to personalized or non-personalized treatment based on a cluster assignment of the West Haven-Yale Multidimensional Pain Inventory (MPI). In the personalized assignment condition, patients with high levels of distress receive an emotional distress-tailored intervention, patients with pain-related interference receive an exposure/extinction-tailored treatment intervention and patients who adapt relatively well to the pain receive a low-level smartphone-based activity diary intervention. In the control arm, patients receive one of the two non-matching interventions. Effect sizes will be calculated for change in core pain outcome domains (pain intensity, physical and emotional functioning, stress experience, participant ratings of improvement and satisfaction) after intervention and at follow-up. Feasibility and safety outcomes will assess rates of recruitment, retention, adherence and adverse events. Additional data on neurobiological and psychological characteristics of the patients are collected to improve treatment allocation in future studies.

conclusionAlthough the call for personalized treatment approaches is widely discussed, randomized controlled trials are lacking. As the personalization of treatment approaches is challenging, both allocation and intervention need to be dynamically coordinated. This study will test the feasibility and safety of a novel study design in order to provide a methodological framework for future multicentre RCTs for personalized pain psychotherapy.

trial registrationGerman Clinical Trials Register, DRKS00022792 ( https://www.drks.de ). Prospectively registered on 04/06/2021.

Indexed as

Chronic painPersonalized allocationPrecision therapyPsychotherapyTreatment personalization

Identifiers

PMID36494768
PMCPMC9732983
OpenAlexW4311283778

What OpenQuestion holds

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LicenceCC BY
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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.