NCT05626049

Brief Summary

The purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older with a primary complaint of low back pain (LBP).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Mar 2023Jun 2027

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

November 15, 2022

Last Update Submit

April 24, 2026

Conditions

Pain, Back

Keywords

painback painlow back painprimary spine provider

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

    The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.

    Baseline, 3 Months

  • Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

    The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.

    Baseline, 3 Months

Secondary Outcomes (14)

  • NIH Low Back Pain Questions

    Baseline, 12 Months

  • Patient Satisfaction

    3 Months

  • Perceived Improvement

    3 Months

  • Patient Experience

    3 Months

  • Total Prescribed Opioid Dosage

    Baseline, 3 Months, 6 Months, 12 Months

  • +9 more secondary outcomes

Other Outcomes (10)

  • Total Prescribed Opioid Dosage

    Up to approximately 24 Months

  • PROMIS Global 10 (v1.2) - Physical Health

    Up to approximately 24 Months

  • PROMIS Global 10 (v1.2) - Mental Health

    Up to approximately 24 Months

  • +7 more other outcomes

Study Arms (2)

Usual Medical Care

ACTIVE COMPARATOR

This group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).

Other: Usual Care

Primary Spine Provider Model

EXPERIMENTAL

This group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care.

Other: Primary Spine Provider Model

Interventions

Primary Spine Provider ModelOTHER

Patients with LBP seeking care at intervention clinics will be offered an appointment with a DC or PT at the initial point of contact.

Also known as: PSP Model
Primary Spine Provider Model
Usual CareOTHER

Patients in this arm will receive usual care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).

Usual Medical Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years and older
  • initiating an outpatient visit for LBP at a participating PCP clinic
  • agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent)

You may not qualify if:

  • inability to provide consent or complete outcome questionnaires
  • positive screening for cauda equina symptoms (loss of total control of bowel/bladder associated with this episode of LBP )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Dartmouth Health

Lebanon, New Hampshire, 03755, United States

Location

Duke Health

Durham, North Carolina, 27713, United States

Location

Related Publications (1)

  • Goode AP, Goertz C, Chakraborty H, Salsbury SA, Broderick S, Levy BT, Ryan K, Settles S, Hort S, Dolor RJ, Chrischilles EA, Kasper S, Stahl JE, Almond C, Reed SD, Shannon Z, Harris D, Daly J, Winokur P, Lurie JD. Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial. BMJ Open. 2025 Mar 26;15(3):e097133. doi: 10.1136/bmjopen-2024-097133.

    PMID: 40139699BACKGROUND

MeSH Terms

Conditions

Back PainPainLow Back Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Goertz, PhD

    Duke Clinical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients, clinicians delivering care, LBP schedulers and site research coordinators will not be blinded to clinic intervention assignment in this pragmatic clinical trial. There will be both blinded and unblinded analysis teams.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Primary care clinics across three academic HCS will be allocated 1:1 to each arm (PSP model versus usual care) of the study. Clinics randomized to provide the PSP model will provide patient information regarding the ACP guideline for LBP and an LBP scheduling assistant will help patients make an appointment with either a DC or PT at the initial point of contact.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

March 14, 2023

Primary Completion

October 17, 2025

Study Completion (Estimated)

June 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

In collaboration with the NCCIH, the Investigators will develop a process to facilitate access to study data and will follow the Department of Health and Human Services guidance regarding HIPAA-compliant data sharing. Access to the limited dataset (Enrolled Cohort) will require a Data Use Agreement and IRB approval. This is a custom dataset created to include just the subset of data needed. Access to the de-identified dataset (Longitudinal Cohort) does not require a Data Use Agreement or IRB approval and is not subject to HIPAA's minimum necessary standards.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will not be shared until the end of the grant period (June 30, 2026).
Access Criteria
De-identified data or limited datasets for proposed use, with appropriate documentation, will be provided via secure transfer methods to the requestor following institutional approval and data use agreements as appropriate.

Locations

US(3)