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Back-on-Track Studying Early Quality Care

Comparison of Two Different Initial Entry Portals of Care for Patients Seeking Care for Musculoskeletal Pain: A Multisite Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522923
Acronym
on-Track
Enrollment
150
Registered
2015-08-13
Start date
2019-01-31
Completion date
2020-01-31
Last updated
2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases

Keywords

Physical Therapy Modalities, Primary Care, Health Services Research

Brief summary

This study is a randomized controlled trial conducted at two clinical sites. The purpose of this study is to determine whether patients with musculoskeletal injuries do better by seeing a primary care provider first versus seeing a physical therapist first. Target enrollment is 150 subjects.

Detailed description

Physical therapists have an important role as initial contact providers for individuals with musculoskeletal disorders. Health care expenditures are on the rise each year in the U.S. and a large proportion is due to musculoskeletal disorders. Despite the rise in spending, there has not been an improvement in outcomes for individuals with musculoskeletal disorders. Furthermore, increased medical spending and utilization could expose patients to iatrogenic harm. Comparative effectiveness studies of different portals of entry would help to determine the most effective pathways for individuals with musculoskeletal disorders to seek care. The purpose of this study is to determine whether patients with musculoskeletal injuries do better by seeing a primary care provider first versus seeing a physical therapist first. Subjects will be enrolled from two sites (Temple University, Philadelphia, PA and Brooke Army Medical Center, San Antonio, TX). Patient self-reported outcomes measures will be collected at baseline and 6 weeks. At 6 months, healthcare utilization will be assessed. The investigators plan to enroll a target sample size of 75 subjects per site (150 total). Descriptive statistics will be computed to characterize the 2 treatment groups with ANCOVA being used to assess differences between treatment groups at 6 weeks, adjusting for baseline values, evaluating the assumption of parallel slopes. The investigators will further investigate sources of systematic differences in response to treatment using methods such as generalized estimating equations and linear mixed effects models. This research will be the first multi-site study to compare effectiveness of these two pathways for individuals with musculoskeletal pain in the U.S. With a growing older adult population, the percentage of individuals who have musculoskeletal pain in the U.S. will only increase over time. This research study is timely and could meet the need for identifying the most effective pathway for individuals with musculoskeletal pain to seek care.

Interventions

OTHERPhysical Therapist

The participant will receive an evaluation and intervention from a physical therapist. The patient will be referred onward to other providers as needed.

OTHERPrimary Care Provider

The participant will receive an evaluation and intervention from a primary care provider. The patient will be referred onward to other providers as needed.

Sponsors

Brooke Army Medical Center
CollaboratorFED
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. A patient at Temple University Employee Health, OR, Brooke Army Medical Center. 2. Able to speak English sufficiently to understand informed consent 3. A patient with a musculoskeletal condition as their primary complaint 4. Greater than 18 years old 5. Within 90 days (3 months) of either initial musculoskeletal onset or repeat acute recurrence of a previous episode

Exclusion criteria

1. Patients have already sought care from provider for their presenting condition for this current episode 2. Patients have an insurance plan that requires them to see an outside provider prior to seeing the study providers

Design outcomes

Primary

MeasureTime frame
Physical function on the 10-item short form PROMIS global health measure6 weeks

Secondary

MeasureTime frame
Overall Improvement on the Global Rating of Change6 weeks
Patient Satisfaction on a Likert scale6 weeks
Acceptability of Symptom State on the PASS6 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability6 weeks
Physical function on the Patient Specific Functional Scale6 weeks
Number of Limited or Light Duty Days to Measure Work Status6 weeks
Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization6 months
Presenteeism as Measured by Participation at Work on Likert Scale6 weeks
Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage6 weeks

Countries

United States

Contacts

Primary ContactHeidi A Ojha, D.P.T.
hojha@temple.edu650-804-0350

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026