Clinical trial NCT04007822: Pain Navigator Tool for Self-management in Back Pain: PATiENCe Trial
Official title: Evaluation of the 'Pain Navigator Tool' During Physiotherapy Consultations in Patients With Chronic Low-back Pain: a Service Evaluation Trial.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Low-back Pain
Self Efficacy
Therapeutic Alliance
Communication
Keywords: low back pain
self-efficacy
therapeutic alliance
communication
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2019-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Semi-Structured Interview
timeFrame: 4 weeks
measure: Change in the Health Care Providers Pain and Impairment Relationship Scale
timeFrame: 0 weeks, 4 weeks and at 1 month follow-up
measure: The Pain Self-Efficacy Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in the Pain Understanding and Confidence Questionnaire
timeFrame: 0 weeks, 4 weeks and at 1 month follow-up
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian university
state: Strathcylde
Study officials:
References: