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

NCT04007822 | Withdrawn

• 1 other identifier: 260667
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

low back pain; self-efficacy; therapeutic alliance; communication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in the Pain Understanding and Confidence Questionnaire

  0 weeks, 4 weeks and at 1 month follow-up

Study Arms (1)

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

Interventions

Pain Navigator Tool 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).

Physiotherapists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• 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

You may not qualify if:

• Patient:
• Low-back pain is not the primary reason for physiotherapy appointment
• Return appointment with physiotherapist

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

Glasgow Caledonian university

Glasgow, Strathcylde, G4 0BA, United Kingdom

Location

MeSH Terms

Conditions

Communication; Low Back Pain

Condition Hierarchy (Ancestors)

Behavior; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)