Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/29/2018
Start Date:April 8, 2018
End Date:December 30, 2018
Contact:Kory J Zimney, DPT
Email:kory.zimney@usd.edu
Phone:6056586373

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To investigate whether changes in trust between physical therapist and patient correlate to
outcomes after receiving physical therapy care. We will be utilizing established
questionnaires from the medical literature and one new generated questionnaire.

1. The clinic site staff and physical therapist will fill out facility consent form to
participate as a treatment site. The treating physical therapist participant will
complete an informed consent form at their clinic site, if willing to participate via
phone call with PI. If they consent, they will fill in a demographics form and be given
an ID# that will be used for data collection by PI after informed consent received. This
will take about 5 minutes.

2. Front office staff at each physical therapy clinic will provide recruitment letter for
each new patient that potentially meets inclusion/exclusion criteria (coming into the
clinic with low back that has persisted for greater than 3 month). If patient agrees to
participate, they will fill out informed consent and HIPPA form on-line via PsychData
link provided to them by clinic staff.

3. After completing the informed consent process, the patient participant will complete the
necessary forms provided in PsychData link prior to the initial visit (Baseline
demographics, General Trust in Physician Scale, Wake Forest Scale, Trust in Physician
Scale, Patient Care Assessment Survey, Modified Oswestry Disability Index, Numeric Pain
Rating Scale) Completing the forms will take place in the waiting room as they fill out
their other normal initial paperwork needed for clinic site. This should take about
10-15 minutes. The forms will be handled electronically as the information is placed in
the PI's individual PsychData account. The therapist participants will be blinded to
research questionnaires information through the whole research project.

4. The patient then will receive a normal physical therapy initial evaluation and treatment
as directed by the physical therapist based on the patient presentation.

5. At the conclusion of the initial visit, the patient participant will complete the
necessary forms on-line through a second PsychData link (Wake Forest Scale, Trust in
Physician Scale, Patient Care Assessment Survey, Working Alliance Inventory - Short
Revised). This should take about 5-10 minutes.

6. Participant will continue to receive normal physical therapy care as directed by the
physical therapist based on patient presentation. The majority of the visits (80%) have
to be with the initial physical therapist involved in the care of the patient for that
patient participant to be eligible for the study. The patient participant will still be
eligible for all the gift cards even if they are eventually excluded due to not seeing
the same therapist for 80% of the visits.

7. At the conclusion of care for the current episode (or at the end of 6 months of
continual care by the provider), the patient participant will fill out forms on line to
a third PsychData link (Wake Forest Scale, Trust in Physician Scale, Patient Care
Assessment Survey, Working Alliance Inventory - Short Revised, Modified Oswestry
Disability Index, Numeric Pain Rating Scale, Global Rate of Change). This should take
about 10-15 minutes. If the patient is a no show and does not return for follow up
visits, the principle investigator will send follow up letters to try to get final
surveys completed.

8. After the second visit, the treating physical therapist will complete a PT Survey of
Patient Connection and Engagement form on the patient via an on-line PyschData link.
This will take less than 5 minutes. Treating therapist participant will be notified by
PI that patient has consented into the study. This on-line PsychData information will be
kept confidential from the patient participant.

9. At the conclusion of care (or 6 month time period), the physical therapist and clinic
site will complete appropriate forms (PT Survey of Patient Connection and Engagement,
number of visits, compliance (no show/cancellations), discharge disposition, and Current
Procedural Terminology (CPT) billing codes for patients care) and send back to the
principle investigator.

Inclusion Criteria:

- age range 18 years of age or older, able to speak and read English, seeking physical
therapy treatment for persistent low back pain of 3 months or greater. Being treated
by a PT participant in the study

Exclusion Criteria:

- younger than 18 years of age, unable to speak or read English, patient needing to be
referred out at any time for different level of medical care, concurrent pregnancy or
cancer diagnosis, initial treating physical therapist does not see patient for 80% of
treatments during episode of care
We found this trial at
5
sites
Perry Hall, Maryland 21236
Phone: 410-529-3303
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2519 North Hillcrest Parkway
Altoona, Wisconsin 54720
Phone: 715-271-0388
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Casa Grande, Arizona 85122
Phone: 505-879-0495
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Kent, Washington 98032
Phone: 425-226-7827
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Montclair, New Jersey 07042
Phone: 973-429-6712
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Montclair, NJ
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