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

NCT ID: NCT04007822

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-03-01

Brief Summary

This study explores the experience of physiotherapists and patients using the Pain Navigator Tool during outpatient musculoskeletal consultations.

Detailed Description

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.

Conditions

Chronic Low-back Pain; Self Efficacy; Therapeutic Alliance; Communication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pain Navigator Tool

Intervention Type: BEHAVIORAL

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).

Interventions

Pain Navigator Tool

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

Glasgow Caledonian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glasgow Caledonian university

Glasgow, Strathcylde, United Kingdom

Countries

United Kingdom

Other Identifiers

260667

Identifier Type: -

Identifier Source: org_study_id