Condition or disease | Intervention/treatment |
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Chronic Low-back Pain Self Efficacy Therapeutic Alliance Communication | Behavioral: Pain Navigator Tool |
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:
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Evaluation of the 'Pain Navigator Tool' During Physiotherapy Consultations in Patients With Chronic Low-back Pain: a Service Evaluation Trial. |
Actual Study Start Date : | July 1, 2019 |
Actual Primary Completion Date : | March 1, 2020 |
Actual Study Completion Date : | March 1, 2020 |
Group/Cohort | Intervention/treatment |
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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.
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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).
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Patient:
Physiotherapist:
Exclusion Criteria:
Patient:
United Kingdom | |
Glasgow Caledonian university | |
Glasgow, Strathcylde, United Kingdom, G4 0BA |
Tracking Information | |||||
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First Submitted Date | May 23, 2019 | ||||
First Posted Date | July 5, 2019 | ||||
Last Update Posted Date | February 16, 2021 | ||||
Actual Study Start Date | July 1, 2019 | ||||
Actual Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
Change in the Pain Understanding and Confidence Questionnaire [ Time Frame: 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.
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Original Secondary Outcome Measures |
Change in the Pain Understanding and Confidence Questionnaire [ Time Frame: 0 weeks, 4 weeks and at 1 month follow-up ] The PUnCQ is selected to evaluate the level of understanding and confidence of physiotherapists with regards to chronic pain. It has yet to be validated in this population.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 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. | ||||
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:
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. |
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Condition |
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Intervention | 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).
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Study Groups/Cohorts | 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.
Intervention: Behavioral: Pain Navigator Tool
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
8 | ||||
Actual Study Completion Date | March 1, 2020 | ||||
Actual Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria: Patient:
Physiotherapist:
Exclusion Criteria: Patient:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04007822 | ||||
Other Study ID Numbers | 260667 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Glasgow Caledonian University | ||||
Study Sponsor | Glasgow Caledonian University | ||||
Collaborators | NHS Greater Glasgow and Clyde | ||||
Investigators | Not Provided | ||||
PRS Account | Glasgow Caledonian University | ||||
Verification Date | February 2021 |