Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management

NCT ID: NCT05336903

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-24

Study Completion Date

2023-12-31

Brief Summary

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The current study is intended to evaluate the feasibility of conducting a future trial to evaluate the effects of implementing an advanced practice physiotherapist (APP) role within a chronic pain clinic setting.

Detailed Description

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This line of research ultimately seeks to assess the impact of integrating an APP as the first point of contact within interprofessional chronic pain clinics on patient health outcomes, care provided to patients, chronic pain clinic flow, and cost-utility in comparison to usual physician or nurse practitioner-led care.

The primary objectives of the feasibility study are:

1. To determine the feasibility of implementing the trial methods by evaluating participant recruitment rates, retention, and assessment completion at each of four follow-up time-points over a 12-month period.
2. To determine the feasibility of implementing the new APP model of care by monitoring the care provided and treatment fidelity.
3. To explore the perspectives of participants and health care providers related to the acceptability of the APP role; barriers, facilitators, and strategies for refining implementation; and perceived impact on clinic processes and outcomes.

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-arm feasibility study at the one chronic pain clinic in Kingston, Ontario, Canada. The intervention is the integration of an APP as the first point of contact in this interprofessional setting.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Participants will be invited to participate in the study with an understanding that they will be assigned to either a model of care in which they see the physician or nurse practitioner first or a model of care in which they see a physiotherapist first, even though this is a single arm feasibility study and all participants will be assigned to the APP model of care. This partial masking at the time of consent and initial assessment was determined to be important to provide accurate estimates of feasibility (e.g. consent rate, percentage of consenting participants who see the physiotherapist first who also request to see the physician or nurse practitioner). Due to the nature of the intervention, participants and healthcare providers will not be blinded to the intervention received in this or the fully powered trial. Since the primary outcome measures are self-report measures (ie. the participant is the assessor), the outcome assessor is similarly not planned to be blinded.

Study Groups

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APP-led model of care for chronic pain management

The APP-led model of care involves integrating an APP as the first point of contact within an interprofessional chronic pain clinic setting. This is in contrast to the usual physician- or nurse practitioner-led model of care.

Group Type EXPERIMENTAL

APP-led model of care for chronic pain management

Intervention Type BEHAVIORAL

The APP will provide an assessment using a biopsychosocial approach. The assessment will include:

* taking a comprehensive history
* screening for pathologies contributing to the participant's chronic pain
* a physical assessment
* screening for comorbid health conditions, using the appropriate screening tools, that require specific care (e.g., depression, addiction, post-traumatic stress)
* identifying psychosocial risk factors associated with pain and disability
* evaluating pain severity and interference

The APP will make recommendations to the participant and the chronic pain clinic health care team based on findings from the comprehensive assessment. These recommendations include, but are not limited to, the need for urgent or emergent referrals, medication management, referral and integration of other health care providers, the need for interventional procedures, or group-based treatment options.

Interventions

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APP-led model of care for chronic pain management

The APP will provide an assessment using a biopsychosocial approach. The assessment will include:

* taking a comprehensive history
* screening for pathologies contributing to the participant's chronic pain
* a physical assessment
* screening for comorbid health conditions, using the appropriate screening tools, that require specific care (e.g., depression, addiction, post-traumatic stress)
* identifying psychosocial risk factors associated with pain and disability
* evaluating pain severity and interference

The APP will make recommendations to the participant and the chronic pain clinic health care team based on findings from the comprehensive assessment. These recommendations include, but are not limited to, the need for urgent or emergent referrals, medication management, referral and integration of other health care providers, the need for interventional procedures, or group-based treatment options.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chronic musculoskeletal pain (pain \> 3 months in duration) (e.g., neck pain, thoracic pain, limb pain, low back pain) -OR-
* Chronic widespread pain (e.g., fibromyalgia, myofascial syndrome) -AND-
* 18 years of age or older -AND-
* Must be able to read, write, and speak English

Exclusion Criteria

* Primary reason for referral stated as medication change or interventional pain management (e.g., injections, nerve block)
* Primary reason for referral is stated as headache or migraine.
* Reason for referral is chronic pelvic pain
* Referral includes information that patient has an untreated addiction, mental health disorder, or substance use disorder
* Referral indicates cancer-related pain
* Referral indicates medical "red flags" suggestive of non-musculoskeletal etiology of symptoms (e.g., unexplained symptoms, sudden weight loss, urinary retention, saddle anesthesia, evidence of upper motor neuron lesion, or fever)
* Referral states visceral pain or abdominal pain.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Kingston Foundation - Women's Giving Circle

UNKNOWN

Sponsor Role collaborator

Jordan Miller, PT, PhD

OTHER

Sponsor Role lead

Responsible Party

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Jordan Miller, PT, PhD

Assistant Professor, School of Rehabilitation Therapy, Queen's University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jordan Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic

Kingston, Ontario, Canada

Site Status

Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Miller J, Doulas T, Bisson EJ, Abebe A, Chala M, McClintock C, Varette K, Vader K, Desmeules F, Perreault K, Donnelly C, Booth R, Tawiah AK, Duggan S. Assessing the feasibility of a clinical trial to evaluate an advanced practice physiotherapy model of care in chronic pain management: a feasibility study. Pilot Feasibility Stud. 2023 Jul 17;9(1):125. doi: 10.1186/s40814-023-01352-9.

Reference Type DERIVED
PMID: 37461072 (View on PubMed)

Other Identifiers

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REH-782-20

Identifier Type: -

Identifier Source: org_study_id

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