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

NCT05336903 | Completed

• 1 other identifier: REH-782-20
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Feasibility study

Outcome Measures

Primary Outcomes (9)

• Participant recruitment

  Recruitment rate (participants/week) over 8 weeks.

  Baseline to 8 weeks

• Assessment completion

  Proportion of all assessment items completed over the study duration (includes assessment items from baseline and 3, 6, 9, and 12 months follow-up)

  12 months

• Duration of baseline survey completion

  Mean time to complete the baseline survey

  Baseline

• Duration of follow-up survey completion

  Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)

  12 months

• Participant attrition

  Attrition of participants expressed as a percentage lost to follow-up at 12 months.

  12 months

• Transfer of care

  Percentage of cases where the APP can successfully fulfill the role without having to transfer care to a physician or nurse practitioner as the most responsible provider.

  Baseline to 8 weeks

• Treatment fidelity

  Fidelity checklist for the APP intervention. Percentage of red flags screened for and percentage completion of all other assessment items.

  Baseline to 8 weeks

• Participant perspectives

  Semi-structured interviews with participants involved in the study to explore acceptability of and satisfaction with the APP model of care.

  1-2 months after visit with APP

• Health care provider perspectives

  Semi-structured interviews with health care providers involved in the study to explore acceptability of and satisfaction with the APP model of care.

  1-2 months after visit with APP

Secondary Outcomes (13)

• Brief Pain Inventory - pain severity subscale

  Baseline and 3, 6, 9, and 12 months follow-up

• Brief Pain Inventory - pain interference subscale

  Baseline and 3, 6, 9, and 12 months follow-up

• Health-related quality of life

  Baseline and 3, 6, 9, and 12 months follow-up

• Pain Catastrophizing Scale

  Baseline and 3, 6, 9, and 12 months follow-up

• Tampa Scale of Kinesiophobia

  Baseline and 3, 6, 9, and 12 months follow-up

Other Outcomes (2)

• Baseline measures

  Baseline

• Comorbidities

  Baseline

Study Arms (1)

APP-led model of care for chronic pain management

EXPERIMENTAL

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.

Behavioral: APP-led model of care for chronic pain management

Interventions

APP-led model of care for chronic pain management 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.

APP-led model of care for chronic pain management

Eligibility Criteria

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

You may qualify if:

• 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-
• years of age or older -AND-
• Must be able to read, write, and speak English

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan Miller, PT, PhD: lead
• University Hospitals Kingston Foundation - Women's Giving Circle: collaborator

Study Sites (2)

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

Kingston, Ontario, K7L 3N6, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 37461072 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jordan Miller, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, School of Rehabilitation Therapy, Queen's University

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 20, 2022
• Study Start: June 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)