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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02272257
Recruitment Status : Unknown
Verified April 2017 by Temple University.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Diseases Behavioral: Early Direct Access Physical Therapy Behavioral: Physician management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Direct Access Physical Therapy Compared With Physician Portal of Entry for Temple University Employees With Recent Onset Musculoskeletal Conditions: A Randomized Controlled Trial.
Actual Study Start Date : April 7, 2015
Estimated Primary Completion Date : April 28, 2018
Estimated Study Completion Date : April 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Early Direct Access Physical Therapy
All care will be administered by one or more physical therapists employed by Temple University. This arm will be early, direct access, physical therapy (immediately evaluation following contacting the front desk administrator or reporting a work injury). Intervention will include interventions matched to their stratified risk category incorporating biopsychosocially oriented education, therapeutic exercise, and manual therapy tailored to the patient's needs.
Behavioral: Early Direct Access Physical Therapy
Physical Therapy management including Manual therapy, Exercise, and education including cognitive behavioral therapy.
Other Name: Physiotherapy management

Active Comparator: Physician management
All usual care by physician will be administered by one or more employee health physicians employed by Temple University. Recommendations may or may not include referral to physical therapy.
Behavioral: Physician management
Physician management including advice, medication, and referral to physical therapy or other provider.

Primary Outcome Measures :
  1. Total Episode Cost and codes billed affecting cost [ Time Frame: 1 year post study enrollment ]
    Reimbursed 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 Outcome Measures :
  1. PROMIS, 10 item-Physical Function Questionnaire [ Time Frame: 1 month post enrollement ]
    Self report questionnaire to assess function, quality of life

  2. Patient-Specific Functional Scale (PSFS) [ Time Frame: 1 month post enrollment ]
    Self report questionnaire (not region specific)

  3. Pain Catastrophizing Score (PCS) [ Time Frame: 1 month post enrollment ]
    Self-report standardized questionnaire, Theorized mediator

  4. Pain Self-efficacy questionnaire (PSEQ) [ Time Frame: 1 month post enrollment ]
    Self-report standardized questionnaire, Theorized mediator

  5. Patient Satisfaction [ Time Frame: 1 month post enrollment ]
    Self report rating from 0-10

  6. Patient Acceptable Symptom State (PASS) [ Time Frame: 1 month post enrollment ]
    Yes or No response to a written question if their current state is acceptable to patient.

  7. Harm [ Time Frame: 1 month post enrollment ]
    complaints 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02272257

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United States, Pennsylvania
Temple University Employee Health
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
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Principal Investigator: Heidi A Ojha, DPT Temple University

Additional Information:
Publications of Results:
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Responsible Party: Temple University Identifier: NCT02272257    
Other Study ID Numbers: 22290
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Temple University:
Musculoskeletal Pain
Physical Therapists
Drug Prescriptions
Physical Therapy Modalities
Referral and Consultation
Workers' Compensation
United States
Primary Care
Health Services Research
Occupational Health
Additional relevant MeSH terms:
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Musculoskeletal Diseases