Musculoskeletal Diseaseson-TrackNCT02522923
Back-on-Track Studying Early Quality Care
A study testing Physical Therapist and Primary Care Provider in people with Musculoskeletal Diseases, run by Temple University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Physical Therapist and Primary Care Provider
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2019to Jan 2020
- 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
- A patient at Temple University Employee Health, OR, Brooke Army Medical Center.
- Able to speak English sufficiently to understand informed consent
- A patient with a musculoskeletal condition as their primary complaint
- Greater than 18 years old
- Within 90 days (3 months) of either initial musculoskeletal onset or repeat acute recurrence of a previous episode
Who cannot join
- Patients have already sought care from provider for their presenting condition for this current episode
- Patients have an insurance plan that requires them to see an outside provider prior to seeing the study providers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Daniel Rhon, 210-916-6100, daniel.i.rhon.mil@mail.mil
Temple University Employee Health
Philadelphia, Pennsylvania, 19122
Heidi A Ojha, DPT, 650-804-0350, hojha@temple.edu
Mark Denys, MHA, BS, RN, 215-204-7391, Mark.Denys@tuhs.temple.edu
About this study
Official title: Comparison of Two Different Initial Entry Portals of Care for Patients Seeking Care for Musculoskeletal Pain: A Multisite Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Physical Therapist, Primary Care Provider
- Keywords
- Physical Therapy Modalities, Primary Care, Health Services Research
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapistOther
The participant will receive an evaluation and intervention from a physical therapist. The patient will be referred onward to other providers as needed.
Primary Care ProviderOther
The participant will receive an evaluation and intervention from a primary care provider. The patient will be referred onward to other providers as needed.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapist | Experimental | Participants randomized to this arm will receive care from a physical therapist first. Receives: Other: Physical Therapist |
| Primary Care Provider | Active comparator | Participants randomized to this arm will receive care from a primary care provider first. Receives: Other: Primary Care Provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function on the 10-item short form PROMIS global health measure
Measured: 6 weeks
Secondary outcomes (9)
Physical function on the Patient Specific Functional Scale
Measured: 6 weeks
Overall Improvement on the Global Rating of Change
Measured: 6 weeks
Patient Satisfaction on a Likert scale
Measured: 6 weeks
Acceptability of Symptom State on the PASS
Measured: 6 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 6 weeks
Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage
Measured: 6 weeks
Number of Limited or Light Duty Days to Measure Work Status
Measured: 6 weeks
Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization
Measured: 6 months
Presenteeism as Measured by Participation at Work on Likert Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
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 Musculoskeletal DiseasesStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Heidi A Ojha, D.P.T., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522923
- Sponsor's protocol ID
- 23131
- Acronym
- on-Track
- Status last verified
- Oct 2017
- First submitted
- 29 Jul 2015
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moore JH, McMillian DJ, Rosenthal MD, Weishaar MD. Risk determination for patients with direct access to physical therapy in military health care facilities. J Orthop Sports Phys Ther. 2005 Oct;35(10):674-8. doi: 10.2519/jospt.2005.35.10.674.
PubMed 16294989
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Initial Entry Portals of Care for Patients Seeking Care for Musculoskeletal Pain: A Multisite Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02522923
- Acronym / sponsor ID
- on-Track / 23131
- Conditions
- Musculoskeletal Diseases
- Keywords
- Physical Therapy Modalities, Primary Care, Health Services Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapist | Experimental | Other: Physical TherapistParticipants randomized to this arm will receive care from a physical therapist first. |
| Primary Care Provider | Active comparator | Other: Primary Care ProviderParticipants randomized to this arm will receive care from a primary care provider first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A patient at Temple University Employee Health, OR, Brooke Army Medical Center.
- Able to speak English sufficiently to understand informed consent
- A patient with a musculoskeletal condition as their primary complaint
- Greater than 18 years old
- Within 90 days (3 months) of either initial musculoskeletal onset or repeat acute recurrence of a previous episode
Key exclusion criteria (2 listed)
- Patients have already sought care from provider for their presenting condition for this current episode
- Patients have an insurance plan that requires them to see an outside provider prior to seeing the study providers
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 |
|---|---|---|
| Physical TherapistThe participant will receive an evaluation and intervention from a physical therapist. The patient will be referred onward to other providers as needed. | Other | Physical Therapist |
| Primary Care ProviderThe participant will receive an evaluation and intervention from a primary care provider. The patient will be referred onward to other providers as needed. | Other | Primary Care Provider |
Primary outcome
Physical function on the 10-item short form PROMIS global health measure
Time frame: 6 weeks
9 secondary outcomes
Physical function on the Patient Specific Functional Scale
Time frame: 6 weeks
Overall Improvement on the Global Rating of Change
Time frame: 6 weeks
Patient Satisfaction on a Likert scale
Time frame: 6 weeks
Acceptability of Symptom State on the PASS
Time frame: 6 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 weeks
Percentage of Subjects using Over-the-counter or Prescription Medication to Assess Medication Usage
Time frame: 6 weeks
Number of Limited or Light Duty Days to Measure Work Status
Time frame: 6 weeks
Number of Physical Therapy or Medical Appointments or Tests orders as a Measure of Health care utilization
Time frame: 6 months
Presenteeism as Measured by Participation at Work on Likert Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Results publication: PubMed 16294989Moore JH, McMillian DJ, Rosenthal MD, Weishaar MD. Risk determination for patients with direct access to physical therapy in military health care facilities. J Orthop Sports Phys Ther. 2005 Oct;35(10):674-8. doi: 10.2519/jospt.2005.35.10.674.
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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.
Heidi A Ojha, D.P.T. principal investigator
Temple 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 Physical Therapist and Primary Care Provider in people with Musculoskeletal Diseases, run by Temple University at 2 sites in United States.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi A Ojha, D.P.T. (650-804-0350, hojha@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function on the 10-item short form PROMIS global health measure (time frame: 6 weeks). 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 NCT02522923, 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 11 Oct 2017.