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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

Henrik, Grelz LU orcid ; Patrik, Midlöv LU orcid ; Anders, Håkansson LU ; Ulf, Jakobsson LU orcid ; Marcelo, Rivano Fischer LU and Åsa, Ringqvist LU (2021) In Trials 22.
Abstract

BACKGROUND: Opioids 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... (More)

BACKGROUND: Opioids 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.

METHODS: The 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 REGISTRATION: ClinicalTrials.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.

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author
; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Analgesics, Opioid/adverse effects, Chronic Pain/diagnosis, Cognition, Follow-Up Studies, Humans, Quality of Life, Randomized Controlled Trials as Topic
in
Trials
volume
22
article number
503
publisher
BioMed Central (BMC)
external identifiers
  • pmid:34321058
  • scopus:85111495722
ISSN
1745-6215
DOI
10.1186/s13063-021-05449-5
project
Long-term opioid therapy in chronic non-cancer pain. Prevalence, signs of opioid use disorder and methods for tapering in a tertiary pain unit setting.
language
English
LU publication?
yes
id
3b064c5c-9848-46ab-8d5d-506c4ef5056e
date added to LUP
2021-08-17 11:40:44
date last changed
2024-03-23 07:53:59
@article{3b064c5c-9848-46ab-8d5d-506c4ef5056e,
  abstract     = {{<p>BACKGROUND: Opioids 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.</p><p>METHODS: The 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.</p><p>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.</p><p>TRIAL REGISTRATION: ClinicalTrials.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.</p>}},
  author       = {{Henrik, Grelz and Patrik, Midlöv and Anders, Håkansson and Ulf, Jakobsson and Marcelo, Rivano Fischer and Åsa, Ringqvist}},
  issn         = {{1745-6215}},
  keywords     = {{Analgesics, Opioid/adverse effects; Chronic Pain/diagnosis; Cognition; Follow-Up Studies; Humans; Quality of Life; Randomized Controlled Trials as Topic}},
  language     = {{eng}},
  month        = {{07}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1186/s13063-021-05449-5}},
  doi          = {{10.1186/s13063-021-05449-5}},
  volume       = {{22}},
  year         = {{2021}},
}