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

NCT02272257 | Unknown

• 1 other identifier: 22290
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Total Episode Cost and codes billed affecting cost

  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)

  1 year post study enrollment

Secondary Outcomes (7)

• PROMIS, 10 item-Physical Function Questionnaire

  1 month post enrollement

• Patient-Specific Functional Scale (PSFS)

  1 month post enrollment

• Pain Catastrophizing Score (PCS)

  1 month post enrollment

• Pain Self-efficacy questionnaire (PSEQ)

  1 month post enrollment

• Patient Satisfaction

  1 month post enrollment

Study Arms (2)

Early Direct Access Physical Therapy

EXPERIMENTAL

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

Physician management

ACTIVE COMPARATOR

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

Interventions

Early Direct Access Physical Therapy BEHAVIORAL

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

Also known as: Physiotherapy management

Early Direct Access Physical Therapy

Physician management BEHAVIORAL

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

Physician management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Employee Health

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (5)

• Fritz JM, Childs JD, Wainner RS, Flynn TW. Primary care referral of patients with low back pain to physical therapy: impact on future health care utilization and costs. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2114-21. doi: 10.1097/BRS.0b013e31825d32f5.

  PMID: 22614792 RESULT

• Ojha HA, Snyder RS, Davenport TE. Direct access compared with referred physical therapy episodes of care: a systematic review. Phys Ther. 2014 Jan;94(1):14-30. doi: 10.2522/ptj.20130096. Epub 2013 Sep 12.

  PMID: 24029295 RESULT

• Wand BM, Bird C, McAuley JH, Dore CJ, MacDowell M, De Souza LH. Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise. Spine (Phila Pa 1976). 2004 Nov 1;29(21):2350-6. doi: 10.1097/01.brs.0000143619.34308.b4.

  PMID: 15507794 RESULT

• Zigenfus GC, Yin J, Giang GM, Fogarty WT. Effectiveness of early physical therapy in the treatment of acute low back musculoskeletal disorders. J Occup Environ Med. 2000 Jan;42(1):35-9. doi: 10.1097/00043764-200001000-00010.

  PMID: 10652686 RESULT

• Ojha HA, Fritz JM, Malitsky AL, Wu J, Weiner MG, Brandi JA, Rhon DI, Mobo BHP, Fleming KM, Beidleman RR, Wright WG. Comparison of Physical Therapy and Physician Pathways for Employees with Recent Onset Musculoskeletal Pain: A Randomized Controlled Trial. PM R. 2020 Nov;12(11):1071-1080. doi: 10.1002/pmrj.12382. Epub 2020 May 23.

  PMID: 32281269 DERIVED

Related Links

• Direct Access PT model in Nova Scotia for occupational soft tissue injuries

MeSH Terms

Conditions

Musculoskeletal Diseases; Musculoskeletal Pain

Interventions

Practice Management

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Heidi A Ojha, DPT

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: April 7, 2015
• Primary Completion: April 28, 2018
• Study Completion: April 28, 2018
• Last Updated: October 11, 2017

Record last verified: 2017-04

Locations

US (1)