Pain Navigator Tool for Self-management in Back Pain: PATiENCe Trial (PATiENCe)
15 de fevereiro de 2021 atualizado por: Glasgow Caledonian University
Evaluation of the 'Pain Navigator Tool' During Physiotherapy Consultations in Patients With Chronic Low-back Pain: a Service Evaluation Trial.
This study explores the experience of physiotherapists and patients using the Pain Navigator Tool during outpatient musculoskeletal consultations.
Visão geral do estudo
Status
Retirado
Intervenção / Tratamento
Descrição detalhada
Chronic pain is the largest cause of disability globally and affects up to 28 million people in the UK alone. Nearly half of those who experienced chronic pain in Europe reported receiving insufficient pain management. Conventional treatments commonly used in physiotherapy continue to show only moderate effects in pain management. A potential avenue to improve the global effect of treatments may lie in exploring non-specific treatment moderators such as the therapeutic alliance (TA). Findings suggest that it is linked with engagement in rehabilitation and is a strong predictor of treatment outcomes and adherence. This study aims to evaluate and compare the quality of practice with or without the Pain Navigator Tool (PNT). Understanding the impact of the PNT on therapeutic alliance would open an avenue to improve chronic pain management, reduce healthcare-related expenses and increase the quality of life in the population studied. In addition, exploring the experience of the physiotherapists with using the PNT will provide an in-depth understanding of its use and applicability in similar settings.
The aims of this study are to:
- To evaluate and compare the quality of practice with or without the PNT in patients with chronic low-back.
- To collect preliminary data on the usability and practicality of the PNT for physiotherapists.
Tipo de estudo
Observacional
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Strathcylde
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Glasgow, Strathcylde, Reino Unido, G4 0BA
- Glasgow Caledonian University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Physiotherapists working in an MSK outpatient clinic and are able to read and speak English to a level allowing satisfactory completion of the study procedures.
Patients with chronic low back pain attending an MSK outpatient clinic.
Descrição
Inclusion Criteria:
Patient:
- Participant aged >18 years
- Low-back pain for more than three months
- Able to read and speak English to a level allowing satisfactory completion of the study procedures
- Initial appointment with a participating physiotherapist
Physiotherapist:
- 2 years of experience in treating patients with chronic pain
- Currently working in an MSK outpatient clinic
- Able to read and speak English to a level allowing satisfactory completion of the study procedures
Exclusion Criteria:
Patient:
- Low-back pain is not the primary reason for physiotherapy appointment
- Return appointment with physiotherapist
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Physiotherapists
Physiotherapists will be recruited using the following inclusion criteria: (1) two years of experience in treating patients with chronic pain, (2) currently working in an MSK outpatient clinic and (3) able to read and speak English to a level allowing satisfactory completion of the study procedures.
There are no exclusion criterium.
Potential participants will be recruited through the relevant gatekeeper.
The gatekeeper will be responsible of forwarding the participant information sheet and consent form to the physiotherapists.
Physiotherapists will be asked to demonstrate their interest by replying to the email.
Any questions will be answered by the research team via email or phone.
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The Pain Navigator Tool (PNT) was developed recently with the aim to empower patients through helping them to discuss their main concerns about pain, and to help therapists to prioritise addressing these concerns (Blomkvist et al., 2018).
The initial pilot study with this tool improved the content of the consultations and patient engagement, and led to better patient-therapist interaction in a small population of healthcare providers and patients (Blomkvist et al., 2018).
As it endeavours to facilitate the implementation of self-management in patients with chronic pain, the PNT aligns with the Scottish Intercollegiate Guidelines Network (SIGN) guideline for chronic pain and the Scottish Government's strategic vision (Scottish Government, 2011; SIGN, 2013).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Semi-Structured Interview
Prazo: 4 weeks
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Semi-structured interviews with the participating physiotherapists will explore the experience using the PNT.
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4 weeks
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Change in the Health Care Providers Pain and Impairment Relationship Scale
Prazo: 0 weeks, 4 weeks and at 1 month follow-up
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The HC-PAIRS is selected to assess the pain-related attitudes and beliefs of physiotherapists.
It is a validated tool with adequate psychometric properties and has already been used in the selected population.
It measures attitudes and beliefs on a scale of 13 to 91 with higher scores on this scale indicating stronger beliefs that LBP validates disability.
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0 weeks, 4 weeks and at 1 month follow-up
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The Pain Self-Efficacy Questionnaire
Prazo: 4 weeks
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The PSEQ is selected to capture the patients' levels of confidence in carrying out day-to-day tasks despite the presence of pain.
It assesses the confidence of people with any type of chronic pain in activity despite pain.
It covers enjoying activities, household daily activities, social life, coping in general, work, leisure activities, coping with pain without medication, accomplishing goals, living a normal lifestyle, and becoming more active, all 'despite pain'.
Each is rated on a 7 point scale from 0 = not at all confident to 6 = completely confident.
The total score, ranging from 0 to 60, is calculated by adding the scores for each item.
Higher scores reflect stronger self-efficacy beliefs.
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4 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in the Pain Understanding and Confidence Questionnaire
Prazo: 0 weeks, 4 weeks and at 1 month follow-up
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The PUnCQ is a two-part questionnaire assessing students' knowledge and understanding of pain alongside their confidence in applying this understanding.
The questionnaire consists of a chronic pain case vignette, with the first set of questions consisting of a 12-item multiple choice questionnaire, assessing knowledge and understanding in the context of the vignette.
The second part of the tool is a 21-item Likert scale ranging from "not at all confident" (0) to "no problem!" (10), with a higher score indicating a higher self-perceived confidence in applying this understanding.
Correct answers in the Understanding section were awarded a score of 1, and incorrect a score of 0, with a total accumulated to give a score for each participant.
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0 weeks, 4 weeks and at 1 month follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de julho de 2019
Conclusão Primária (Real)
1 de março de 2020
Conclusão do estudo (Real)
1 de março de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
23 de maio de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de julho de 2019
Primeira postagem (Real)
5 de julho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de fevereiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de fevereiro de 2021
Última verificação
1 de fevereiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 260667
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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