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Pain Navigator Tool for Self-management in Back Pain: PATiENCe Trial (PATiENCe)

2021年2月15日 更新者: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.

調査の概要

詳細な説明

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:

  1. To evaluate and compare the quality of practice with or without the PNT in patients with chronic low-back.
  2. To collect preliminary data on the usability and practicality of the PNT for physiotherapists.

研究の種類

観察的

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Strathcylde
      • Glasgow、Strathcylde、イギリス、G4 0BA
        • Glasgow Caledonian University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Semi-Structured Interview
時間枠:4 weeks
Semi-structured interviews with the participating physiotherapists will explore the experience using the PNT.
4 weeks
Change in the Health Care Providers Pain and Impairment Relationship Scale
時間枠:0 weeks, 4 weeks and at 1 month follow-up
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.
0 weeks, 4 weeks and at 1 month follow-up
The Pain Self-Efficacy Questionnaire
時間枠:4 weeks
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.
4 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in the Pain Understanding and Confidence Questionnaire
時間枠:0 weeks, 4 weeks and at 1 month follow-up
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.
0 weeks, 4 weeks and at 1 month follow-up

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年7月1日

一次修了 (実際)

2020年3月1日

研究の完了 (実際)

2020年3月1日

試験登録日

最初に提出

2019年5月23日

QC基準を満たした最初の提出物

2019年7月2日

最初の投稿 (実際)

2019年7月5日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月16日

QC基準を満たした最後の更新が送信されました

2021年2月15日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 260667

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いいえ

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