Chronic PainNCT05336903
Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
A study testing APP-led model of care for chronic pain management in people with Chronic Pain, run by Jordan Miller, PT, PhD at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- APP-led model of care for chronic pain management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Kingston Health Sciences Center, Hotel Dieu site - Chronic Pain Clinic
Kingston, Ontario, K7L 3N6
Queen's University
Kingston, Ontario, K7L 3N6
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Being tested
- APP-led model of care for chronic pain management
- Keywords
- Feasibility study
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP-led model of care for chronic pain managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: APP-led model of care for chronic pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Recruitment rate (participants/week) over 8 weeks.
Measured: 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)
Measured: 12 months
Duration of baseline survey completion
Mean time to complete the baseline survey
Measured: Baseline
Duration of follow-up survey completion
Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)
Measured: 12 months
Participant attrition
Attrition of participants expressed as a percentage lost to follow-up at 12 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-2 months after visit with APP
Secondary outcomes (13)
Brief Pain Inventory - pain severity subscale
Numeric rating scale from 0 to 10, with higher scores indicating greater pain.
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Brief Pain Inventory - pain interference subscale
Numeric rating scale from 0 to 10, with higher scores indicating greater pain interference with 7 elements of daily living.
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Health-related quality of life
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)
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Pain Catastrophizing Scale
Score of 0 to 52 with higher scores indicating greater catastrophic thinking.
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Tampa Scale of Kinesiophobia
17 items about pain-related fear. Higher scores (68 highest possible) suggesting worse pain-related fear.
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Pain Self-Efficacy Questionnaire
Score of 0 to 60, with higher scores suggesting higher confidence in dealing with pain.
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Self-reported rating of change
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.
Measured: 3, 6, 9, and 12 months follow-up
Satisfaction with health care
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.
Measured: 3, 6, 9, and 12 months follow-up
Adverse events
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.
Measured: 3, 6, 9, and 12 months follow-up
Care provided
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
Measured: 12 months
Health utilization
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.
Measured: 12 months
Health costs
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.
Measured: 12 months
Indirect costs
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start24 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Miller, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Kingston Foundation - Women's Giving Circle
- Responsible party
- Sponsor-investigator, Jordan Miller, PT, PhD, Queen's University
- Investigators
- Jordan Miller, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336903
- Sponsor's protocol ID
- REH-782-20
- Status last verified
- Mar 2025
- First submitted
- 5 Apr 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Publications
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.
PubMed 37461072
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
- ClinicalTrials.gov ID
- NCT05336903
- Acronym / sponsor ID
- REH-782-20
- Conditions
- Chronic Pain
- Keywords
- Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jordan Miller, PT, PhDUniversity, hospital or other
- Collaborators
- University Hospitals Kingston Foundation - Women's Giving Circle
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| APP-led model of care for chronic pain management | Experimental | Behavioral: APP-led model of care for chronic pain managementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APP-led model of care for chronic pain managementThe 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. | Behavioural | APP-led model of care for chronic pain management |
Primary outcome
Participant recruitment
Time frame: Baseline to 8 weeks
Recruitment rate (participants/week) over 8 weeks.
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)
Duration of baseline survey completion
Time frame: Baseline
Mean time to complete the baseline survey
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)
Participant attrition
Time frame: 12 months
Attrition of participants expressed as a percentage lost to follow-up at 12 months.
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.
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.
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.
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.
13 secondary outcomes
Brief Pain Inventory - pain severity subscale
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Brief Pain Inventory - pain interference subscale
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Health-related quality of life
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Pain Catastrophizing Scale
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Tampa Scale of Kinesiophobia
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Pain Self-Efficacy Questionnaire
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Self-reported rating of change
Time frame: 3, 6, 9, and 12 months follow-up
Satisfaction with health care
Time frame: 3, 6, 9, and 12 months follow-up
Adverse events
Time frame: 3, 6, 9, and 12 months follow-up
Care provided
Time frame: 12 months
Health utilization
Time frame: 12 months
Health costs
Time frame: 12 months
Indirect costs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 37461072Miller 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Miller, PhD principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP-led model of care for chronic pain management in people with Chronic Pain, run by Jordan Miller, PT, PhD at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: Baseline to 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.