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

NCT03443401 | Completed Results

• 1 other identifier: 2017.154
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 11

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.

Conditions

Trust; Chronic Low Back Pain; Physical Therapy

Outcome Measures

Primary Outcomes (6)

• Change in Patient Care Assessment Survey

  Measurement of trust of patient toward provider during clinical encounter. Minimum score of 8, maximal score of 40. Questions 1-7 are scored with a 5-point Likert scale, Question 8 is scored with a 11-point Likert scale. Higher score indicate better levels of trust.

  through study completion, an average of 1 year

• Change in Wake Forest Scale

  Measurement of trust of patient toward provider during clinical encounter. 10 item scale using a 5-point Likert scale. Score range from 10-50, with higher score indicating higher levels of trust.

  through study completion, an average of 1 year

• Change in Trust in Physician Scale

  Measurement of trust of patient toward provider during clinical encounter. 11 item scale using 5-point Likert scale. Score range from 11-55, with higher score indicating higher levels of trust.

  through study completion, an average of 1 year

• Change in Oswestry Disability Index 2.0

  Measurement of function for individuals with low back pain. 10 categories with 6 statements scoring (0-5) for function. Raw scores range from 0-50, they are divided by highest possible score to produce a percentage. Lower percentage demonstrates less disability.

  through study completion, an average of 1 year

• Change in Numeric Pain Rating Scale

  Pain measurement scale. Measurement on 11-point scale from 0= no pain to 10= worst pain imaginable. Measure current, best in last 24 hours, and worst in last 24 hours and take average of all 3 measurements. Lower score represents lower pain rating.

  through study completion, an average of 1 year

• Global Rate of Change

  Global measurement of change of status during care. 11-point scale used (-5=very much worse, 0 = unchanged, 5 = completely recovered). Higher score represents better recovery.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• General Trust in Physician Scale

  through study completion, an average of 1 year

• Change in Working Alliance Inventory - Short Revised

  after initial visit and discontinuation of services, an average of 4-8 weeks.

• Change in PT Survey of Patient Connection and Engagement

  after 2nd visit and discontinuation of services, an average of 4-8 weeks.

Study Arms (2)

patient participants

patients with chronic low back pain receiving standard physical therapy care

Procedure: Standard physical therapy care

Physical Therapy clinician participants

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

Procedure: Standard physical therapy care

Interventions

Standard physical therapy care PROCEDURE

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

Physical Therapy clinician participants; patient participants

Eligibility Criteria

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

Study Population

patients coming to seek care for chronic low back at outpatient physical therapy clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Dakota: lead
• Iowa Physical Therapy Foundation: collaborator

Study Sites (11)

One Accord Physical Therapy Casa Grande

Casa Grande, Arizona, 85122, United States

Location

Foothills Sports Medicine Physical Therapy

Phoenix, Arizona, 85044, United States

Location

Butte Premier Physical Therapy

Chico, California, 95928, United States

Location

Signature Physical Therapy

San Clemente, California, 92673, United States

Location

Rock Valley Physical Therapy

Silvis, Illinois, 61282, United States

Location

Hackensack Meridian Health-Mountainside Medical Center

Montclair, New Jersey, 07042, United States

Location

Miriam Hospital Outpatient Rehab

Providence, Rhode Island, 02904, United States

Location

PRO Physical Therapy

Winchester, Virginia, 22601, United States

Location

Outpatient Physical Therapy

Kent, Washington, 98032, United States

Location

Kitsap Physical Therapy and Sports Clinic

Silverdale, Washington, 98383, United States

Location

Phileo Health

Altoona, Wisconsin, 54720, United States

Location

Results Point of Contact

• Title: Kory Zimney, PhD
• Organization: USouthDakota

kory.zimney@usd.edu

6056586373

Study Officials

• Kory J Zimney, DPT

  University of South Dakota

  PRINCIPAL INVESTIGATOR

• Emilio J Puentedura, DPT, PhD

  University of Nevada, Las Vegas

  STUDY CHAIR

• Morey Kolber, PT, PhD

  Nova Southeastern University

  STUDY DIRECTOR

• Adriaan Louw, PT, PhD

  International Spine and Pain Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 23, 2018
• Study Start: April 8, 2018
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)