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

NCT ID: NCT02272257

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-07
• Study Completion Date: 2018-04-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Direct Access Physical Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Physician management

Intervention Type: BEHAVIORAL

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

Interventions

Early Direct Access Physical Therapy

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

Intervention Type: BEHAVIORAL

Physician management

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Physiotherapy management

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi A Ojha, DPT

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University Employee Health

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22614792 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24029295 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15507794 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10652686 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32281269 (View on PubMed)

Related Links

http://www.directaccesssummit.com/studies/1.pdf

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

Other Identifiers

22290

Identifier Type: -

Identifier Source: org_study_id