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Temple University Employees With Musculoskeletal Conditions Receive Physical Therapy to Treat Limitations Early

Direct Access Physical Therapy Compared With Physician Portal of Entry for Temple University Employees With Recent Onset Musculoskeletal Conditions: A Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02272257
Acronym
TEMPLE
Enrollment
150
Registered
2014-10-22
Start date
2015-04-07
Completion date
2018-04-28
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

Musculoskeletal Pain, Physical Therapists, Drug Prescriptions, Humans, Physical Therapy Modalities, Referral and Consultation, Workers' Compensation, United States, Primary Care, Health Services Research, Triage, Acute, Cost, Occupational Health

Brief summary

The purpose of this study is to determine whether seeing a physical therapist first compared with seeing a physician first is more clinically and cost effective in an occupational setting for acute musculoskeletal conditions.

Detailed description

Traditionally, when individuals sustain a musculoskeletal injury and require physical therapy intervention, a referral is obtained from a physician to prescribe therapy. Currently, for non-work related injuries, 48 out of the 50 United States are direct access physical therapy states meaning a consumer can be evaluated and treated by a physical therapist directly without physician referral. The number of direct access states is much less for work-related injuries, with only 17 of the 50 United States practice acts permitting direct access, and of these, most insurance companies still require a physician referral for reimbursement. A previous systematic review of the literature on this topic suggests that requiring a referral is associated with more drug prescriptions, more imaging ordered, and higher costs to the patient and health care system with no advantage in health outcomes. However, the cited studies were of low quality (i.e. below Level 1 evidence), so a high quality study with strict experimental controls is still necessary. This project proposes to conduct a blinded randomized controlled trial to determine if a direct access physical therapy portal of entry is more effective than a physician portal of entry in decreasing total episode cost and improving outcomes for individuals with a recent onset of musculoskeletal conditions. The project's definition of musculoskeletal pain is any mechanical spine or extremity pain from either a work condition (workers compensation) or a non-work related condition. The project investigators plan to recruit potential subjects directly from Temple University employees and supervisors. Subjects who consent to and pass a baseline screening will be randomized to one of two groups: direct access physical therapy management or Employee Health physician management. All PT and physician providers will be study providers. Subjects randomized to direct access physical therapy will be evaluated and treated by a physical therapist. If the presentation requires further work up, the therapist will refer the patient for imaging or specialty consult. Subjects randomized to the Employee Health physician will receive a similar evaluation ordering relevant work up, and if appropriate, the physician will refer the patient to a physical therapist. Health outcomes for the two groups will be compared with a mixed-model repeated measures analysis at 1 month after enrollment. Total episode cost and medical utilization will be compared at one year after enrollment. If this direct access Temple University model is feasible and effective for managing compensated and non-compensated musculoskeletal conditions, it could serve as a paradigm for other universities to implement across the United States. Furthermore, this study would be the first data set in the literature that studied a physical therapy direct access model for evaluation and treatment of employees with workers-compensation conditions in the United States.

Interventions

BEHAVIORALEarly Direct Access Physical Therapy

Physical Therapy management including Manual therapy, Exercise, and education including cognitive behavioral therapy.

Physician management including advice, medication, and referral to physical therapy or other provider.

Sponsors

Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Temple University Employees who speak English sufficiently to understand informed consent. * Has a primary complaint that is potentially of neuro-musculoskeletal origin. This is defined by a primary complaint of pain, numbness, or decreased function due to symptoms within regions of spine, shoulder, elbow, wrist/hand pain, pelvic/SI, hip, knee, or ankle pain, temporomandibular joint pain, or headaches. The complaint could be work related (workers compensation) or non-work related. This definition does not include abrasions, contusions, etc. that result in pain but do not affect the employee's function. * Age greater than or equal to 18 years old. * Employee's primary complaint began ≤3 months upon initial study screening. This could include a recent exacerbation (within ≤3 months onset) of a condition with a history of previous episodes. If the patient reports more than one complaint, all complaints will be addressed in the study with intervention that began within the ≤3 month timeframe.

Exclusion criteria

* Met with another medical provider for advice for the condition prior to study enrollment (including physical therapist, chiropractor, physician, surgeon, physician-assistant, or nurse, etc.). * Medical history of surgery for a prior episode of complaint. * Any major psychiatric disease in their past medical history. * Red flags cannot be ruled out during the medical screening examination (e.g., cauda equina compression, inflammatory arthritis, malignancy, fracture, serious illness or comorbidity). Any musculoskeletal injuries that can be managed by a physical therapist will not be excluded (radiculopathy, potential ACL tear, peripheral nerve entrapments, etc.)

Design outcomes

Primary

MeasureTime frameDescription
Total Episode Cost and codes billed affecting cost1 year post study enrollmentReimbursed amounts related to initial presenting condition of interest including physical therapy, diagnostics, and all medical interventions (Medication prescriptions, physical therapy visits, physician office visits, specialty visits, imaging ordered, injections performed, number of surgeries performed)

Secondary

MeasureTime frameDescription
Patient-Specific Functional Scale (PSFS)1 month post enrollmentSelf report questionnaire (not region specific)
Pain Catastrophizing Score (PCS)1 month post enrollmentSelf-report standardized questionnaire, Theorized mediator
Pain Self-efficacy questionnaire (PSEQ)1 month post enrollmentSelf-report standardized questionnaire, Theorized mediator
PROMIS, 10 item-Physical Function Questionnaire1 month post enrollementSelf report questionnaire to assess function, quality of life
Patient Acceptable Symptom State (PASS)1 month post enrollmentYes or No response to a written question if their current state is acceptable to patient.
Harm1 month post enrollmentcomplaints voiced to the Workers Compensation Director, adverse events reported in the chart (defined as an undesirable result of the PT evaluation, diagnosis, or prescribed intervention resulting in any short-term or permanent morbidity unexpected for patients with a like clinical presentation), and litigation claims filed.
Patient Satisfaction1 month post enrollmentSelf report rating from 0-10

Countries

United States

Outcome results

None listed

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