Evidence map›Paper›PMID 34321058›Full record

ArticleTrials2021

Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO)-efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled clinical trial with a 12-month follow-up.

Grelz Henrik, Midlöv Patrik, Håkansson Anders, Jakobsson Ulf, Rivano Fischer Marcelo, Ringqvist Åsa

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03485430 (Tapering of Prescribed Opioids in Patients With Long-term Non-malignant Pain - Efficacy and Effects on Pain, Pain Cognitions, and Quality of Life), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03485430 nacompletednot on this map

Tapering of Prescribed Opioids in Patients With Long-term Non-malignant Pain - Efficacy and Effects on Pain, Pain Cognitions, and Quality of Life (TOPIO): a Study Protocol for a Randomized Controlled Clinical Trial With a 12 Month Follow-up

TypeinterventionalSponsorLund University HospitalRan2018 to 2025Enrolled140ConditionsChronic Pain, Analgesics, Opioid, Opioid Withdrawal, Opioid UseArmsTapering
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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.

Grelz HenrikDepartment of Neurosurgery and Pain Rehabilitation, Skåne University Hospital, Lasarettsgatan 13, 221 85, Lund, Sweden. Henrik.grelz@med.lu.se.
Midlöv PatrikCenter for Primary Health Care Research, Faculty of Medicine Department of Clinical Sciences Malmö, Lund University, Jan Waldenströms gata 35, 202 13, Malmö, Sweden.
Håkansson AndersDepartment of Clinical Sciences Lund, Faculty of Medicine, Psychiatry, Lund University, Baravägen 1, 221 00, Lund, Sweden.
Jakobsson UlfCenter for Primary Health Care Research, Faculty of Medicine Department of Clinical Sciences Malmö, Lund University, Jan Waldenströms gata 35, 202 13, Malmö, Sweden.
Rivano Fischer MarceloDepartment of Neurosurgery and Pain Rehabilitation, Skåne University Hospital, Lasarettsgatan 13, 221 85, Lund, Sweden.
Ringqvist ÅsaDepartment of Neurosurgery and Pain Rehabilitation, Skåne University Hospital, Lasarettsgatan 13, 221 85, Lund, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOpioids are still widely prescribed to long-term pain patients although they are no longer recommended for long-term treatments due to poor evidence for long-term efficacy, risks of serious side effects, and the possibility of inducing opioid hyperalgesia. In a Cochrane study from 2017, the authors identified an urgent need for more randomized controlled trials investigating the efficiency and effects of opioid tapering. The study aimed to assess (1) the efficiency of a structured intervention in causing stable reductions of opioid consumption in a population with long-term non-malignant pain and (2) effects on pain, pain cognitions, physical and mental health, quality of life, and functioning in response to opioid tapering.

methodsThe study is a randomized controlled trial. The sample size was set to a total of 140 individuals after estimation of power and dropout. Participants will be recruited from a population with long-term non-malignant pain who will be randomly allocated to (1) the start of tapering immediately or (2) the control group who return to usual care and will commence tapering of opioids 4 months later. A 12-month follow-up is included. When all follow-ups are closed, data from the Swedish drug register of the National Board of Health and Welfare will be collected and individual mean daily opioid dose in morphine equivalents will be calculated at three time points: baseline, 4 months, and 12 months after the start of the intervention. At the same time points, participants fill out the following questionnaires: Numeric Pain Rating Scale (NPRS), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Chronic Pain Acceptance Questionnaire (CPAQ-8), Hospital Anxiety and Depression Scale (HADS), and RAND-36. At baseline and follow-up, a clinical assessment of opioid use disorder is performed. DISCUSSION: A better understanding of the efficiency and effects of opioid tapering could possibly facilitate attempts to taper opioid treatments, which might prove beneficial for both the individual and society.

trial registrationClinicalTrials.gov NCT03485430 . Retrospectively registered on 26 March 2018, first release date. "Tapering of Long-term Opioid Therapy in Chronic Pain Population. RCT with 12 Months Follow up (TOPIO)." First patient in trial 22 March 2018.

Indexed as

Analgesics, OpioidChronic PainCognitionFollow-Up StudiesHumansQuality of LifeRandomized Controlled Trials as TopicAnalgesics, OpioidChronic painFunctioningLong-term painMental healthOpioidOpioid use disorderPhysical healthPrescribedQuality of lifeTapering

Identifiers

PMID34321058
PMCPMC8318331

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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.