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Completed

NCT Number: NCT05336903

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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:

  • 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.
  • To determine the feasibility of implementing the new APP model of care by monitoring the care provided and treatment fidelity.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

(as identified in referral package):

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Participant recruitment

    Time frame: Baseline to 8 weeks

    Recruitment rate (participants/week) over 8 weeks.

  2. Assessment completion

    Time frame: 12 months

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

  3. Duration of baseline survey completion

    Time frame: Baseline

    Mean time to complete the baseline survey

  4. Duration of follow-up survey completion

    Time frame: 12 months

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

  5. Participant attrition

    Time frame: 12 months

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

  6. Transfer of care

    Time frame: Baseline to 8 weeks

    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.

  7. Treatment fidelity

    Time frame: Baseline to 8 weeks

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

  8. Participant perspectives

    Time frame: 1-2 months after visit with APP

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

  9. Health care provider perspectives

    Time frame: 1-2 months after visit with APP

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

Secondary outcomes

  1. Brief Pain Inventory - pain severity subscale

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Numeric rating scale from 0 to 10, with higher scores indicating greater pain.

  2. Brief Pain Inventory - pain interference subscale

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Numeric rating scale from 0 to 10, with higher scores indicating greater pain interference with 7 elements of daily living.

  3. Health-related quality of life

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    EuroQoL-5D-5L. This measure can be used in economic evaluations of health interventions. An index value is assigned and the EQ VAS is incorporated (0-100 scale, with higher scores representing better perceived health)

  4. Pain Catastrophizing Scale

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Score of 0 to 52 with higher scores indicating greater catastrophic thinking.

  5. Tampa Scale of Kinesiophobia

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    17 items about pain-related fear. Higher scores (68 highest possible) suggesting worse pain-related fear.

  6. Pain Self-Efficacy Questionnaire

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Score of 0 to 60, with higher scores suggesting higher confidence in dealing with pain.

  7. Self-reported rating of change

    Time frame: 3, 6, 9, and 12 months follow-up

    Global rating of change scale of -5 to +5, with negative values showing a worsening of functional abilities and positive values an improvement in functional abilities.

  8. Satisfaction with health care

    Time frame: 3, 6, 9, and 12 months follow-up

    Satisfaction with care will be assessed using an 11-point scale (-5 to +5). Negative scores demonstrate dissatisfaction and positive score suggest satisfaction with care.

  9. Adverse events

    Time frame: 3, 6, 9, and 12 months follow-up

    Survey to ask participants if they experienced any adverse events related to treatment received. This includes the type of adverse event experienced, how long the event lasted, how bothersome the event was (0-10 scale), and what the participant thought caused the event.

  10. Care provided

    Time frame: 12 months

    To describe the care provided, the investigators will present counts of following information from the participant's electronic medical records:

    • prescriptions for medications
    • assessments completed
    • interventions delivered
    • requisitions for diagnostic images
    • referrals to other health care providers
    • visits to other health care providers within the chronic pain clinic
    • notes to employers or insurers

  11. Health utilization

    Time frame: 12 months

    From self-reported surveys, the investigators will collect the following health utilization measure counts related to the participant's chronic pain: emergency department visits, overnight hospitalizations, diagnostic images received, surgical interventions and pain injections/procedures, primary care visits (including walk-in clinic visits), specialist visits, medications used, other health care provider appointments (physiotherapy, occupational therapy, chiropractic, massage therapy, social worker visits, psychology), and self-care assistance required. These measures will be captured at 3, 6, 9, and 12 months to obtain cumulative measures and reduce the risk of recall bias. Note: medications will also be captured at baseline.

  12. Health costs

    Time frame: 12 months

    Using the health utilization measures, cumulative direct healthcare costs (total costs and by health utilization measure) will be calculated using the Ontario Ministry of Health and Long-term Care Schedule of Benefits for publicly funded services and the Ontario Drug Benefit formulary for medication costs. For private services (e.g. PT in the community), the mean cost for the services in Kingston will be used.

  13. Indirect costs

    Time frame: 12 months

    Indirect costs will be restricted to loss of productivity using a human capital approach. A dollar value will be assigned to time lost from paid employment (part-time, full-time, and self-employment) based on the mean wage in Ontario, according to Statistics Canada. The minimum wage in Ontario will be used to assign a value to time lost from volunteering, caregiving, or homemaking activities.

Other outcomes

  1. Baseline measures

    Time frame: Baseline

    To describe the study population, the investigators will capture the following through the survey: age, gender, sex, education, identification as a member of a racialized group, identification as indigenous (First Nations, Inuit, Métis), duration and location of pain, current medications, work status, and annual household income.

  2. Comorbidities

    Time frame: Baseline

    Self-Administered Comorbidity Questionnaire. Participants select relevant comorbidities from a list of specific problems (with three optional, open-ended conditions), whether they receive treatment for the condition, and whether the problem limits their activities.

Sponsors and collaborators

Lead sponsor

Jordan Miller, PT, PhD

Other

Collaborators

  • University Hospitals Kingston Foundation - Women's Giving Circle

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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