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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Low-back Pain; Communication; Self Efficacy; Therapeutic Alliance
• Intervention / Treatment: Behavioral: Pain Navigator Tool

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • Strathcylde
    • Glasgow, Strathcylde, United Kingdom, G4 0BA
      • Glasgow Caledonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi-Structured Interview	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Pain Understanding and Confidence Questionnaire	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

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University
• Collaborators: NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: communication; low back pain; self-efficacy; therapeutic alliance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 260667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No