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

NCT ID: NCT03443401

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-08
• Study Completion Date: 2020-09-24

Brief Summary

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.

Detailed Description

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.

Conditions

Trust; Chronic Low Back Pain; Physical Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

patient participants

patients with chronic low back pain receiving standard physical therapy care

Standard physical therapy care

Intervention Type: PROCEDURE

standard plan of care delivered to patient with chronic low back within scope of licensure

Physical Therapy clinician participants

Licensed physical therapist that is providing standard physical therapy care for a patient participant

Standard physical therapy care

Intervention Type: PROCEDURE

standard plan of care delivered to patient with chronic low back within scope of licensure

Interventions

Standard physical therapy care

standard plan of care delivered to patient with chronic low back within scope of licensure

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

Iowa Physical Therapy Foundation

OTHER

Sponsor Role: collaborator

University of South Dakota

OTHER

Sponsor Role: lead

Responsible Party

Kory Zimney, PT, DPT, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kory J Zimney, DPT

Role: PRINCIPAL_INVESTIGATOR

University of South Dakota

Emilio J Puentedura, DPT, PhD

Role: STUDY_CHAIR

University of Nevada, Las Vegas

Morey Kolber, PT, PhD

Role: STUDY_DIRECTOR

Nova Southeastern University

Adriaan Louw, PT, PhD

Role: STUDY_DIRECTOR

International Spine and Pain Institute

Locations

One Accord Physical Therapy Casa Grande

Casa Grande, Arizona, United States

Foothills Sports Medicine Physical Therapy

Phoenix, Arizona, United States

Butte Premier Physical Therapy

Chico, California, United States

Signature Physical Therapy

San Clemente, California, United States

Rock Valley Physical Therapy

Silvis, Illinois, United States

Hackensack Meridian Health-Mountainside Medical Center

Montclair, New Jersey, United States

Miriam Hospital Outpatient Rehab

Providence, Rhode Island, United States

PRO Physical Therapy

Winchester, Virginia, United States

Outpatient Physical Therapy

Kent, Washington, United States

Kitsap Physical Therapy and Sports Clinic

Silverdale, Washington, United States

Phileo Health

Altoona, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017.154

Identifier Type: -

Identifier Source: org_study_id