- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443401
Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
September 25, 2020 updated by: Kory Zimney, University of South Dakota
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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.
- 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.
- 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.
- The patient then will receive a normal physical therapy initial evaluation and treatment as directed by the physical therapist based on the patient presentation.
- 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.
- 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.
- 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.
- 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.
- 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.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Casa Grande, Arizona, United States, 85122
- One Accord Physical Therapy Casa Grande
-
Phoenix, Arizona, United States, 85044
- Foothills Sports Medicine Physical Therapy
-
-
California
-
Chico, California, United States, 95928
- Butte Premier Physical Therapy
-
San Clemente, California, United States, 92673
- Signature Physical Therapy
-
-
Illinois
-
Silvis, Illinois, United States, 61282
- Rock Valley Physical Therapy
-
-
New Jersey
-
Montclair, New Jersey, United States, 07042
- Hackensack Meridian Health-Mountainside Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02904
- Miriam Hospital Outpatient Rehab
-
-
Virginia
-
Winchester, Virginia, United States, 22601
- PRO Physical Therapy
-
-
Washington
-
Kent, Washington, United States, 98032
- Outpatient Physical Therapy
-
Silverdale, Washington, United States, 98383
- Kitsap Physical Therapy and Sports Clinic
-
-
Wisconsin
-
Altoona, Wisconsin, United States, 54720
- Phileo Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients coming to seek care for chronic low back at outpatient physical therapy clinics
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patient participants
patients with chronic low back pain receiving standard physical therapy care
|
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 plan of care delivered to patient with chronic low back within scope of licensure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Care Assessment Survey
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General trust in physician scale
Time Frame: through study completion, an average of 1 year
|
global trust measurement of patient
|
through study completion, an average of 1 year
|
Change in Working alliance inventory - short revised
Time Frame: after initial visit and discontinuation of services, an average of 4-8 weeks.
|
therapeutic alliance measurement
|
after initial visit and discontinuation of services, an average of 4-8 weeks.
|
Change in PT survey of patient connection and engagement
Time Frame: after 2nd visit and discontinuation of services, an average of 4-8 weeks.
|
Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care
|
after 2nd visit and discontinuation of services, an average of 4-8 weeks.
|
Number of PT visits
Time Frame: discontinuation of services, an average of 4-8 weeks.
|
actual number of visits seen during duration of care
|
discontinuation of services, an average of 4-8 weeks.
|
Patient visit compliance
Time Frame: discontinuation of services, an average of 4-8 weeks.
|
no show and cancellations of scheduled appointments.
A no show will be defined for purposes of this study, as any time a patient does not show for a scheduled visit.
A cancellation will be defined as, anytime a patient contacts the clinic site prior to their visit to cancel the visit and does not schedule a subsequent visit to make up for that cancelled visit
|
discontinuation of services, an average of 4-8 weeks.
|
Discontinuation disposition
Time Frame: discontinuation of services, an average of 4-8 weeks.
|
level of patient at discontinuation of services.
1 = Patient met all goals and current episode discontinued by PT and patient, 2 = Patient met at least one, but not all, goals and current episode discontinued by PT and patient, 3 = Patient did not meet goals and current episode discontinued by PT and patient, 4 = Patient discontinued due to financial constraints with continued care, 5 = Patient self-discharged prior to meeting goals (no show for continued visits), 6 = Patient still receiving care after 6 months from initial visit, 7 = Patient had to be referred out for additional health care from different provider, 8 = Other
|
discontinuation of services, an average of 4-8 weeks.
|
CPT codes
Time Frame: discontinuation of services, an average of 4-8 weeks.
|
billing information (current procedural terminology - CPT) through course of care.
Specific billed codes based on amount and type will be analyzed in relation to outcome variables.
|
discontinuation of services, an average of 4-8 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kory J Zimney, DPT, University of South Dakota
- Study Chair: Emilio J Puentedura, DPT, PhD, University of Nevada, Las Vegas
- Study Director: Morey Kolber, PT, PhD, Nova Southeastern University
- Study Director: Adriaan Louw, PT, PhD, International Spine and Pain Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 8, 2018
Primary Completion (ACTUAL)
September 24, 2020
Study Completion (ACTUAL)
September 24, 2020
Study Registration Dates
First Submitted
February 2, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (ACTUAL)
February 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 25, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017.154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All data will be used as part of research project for dissertation purposes and not shared to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.Active, not recruitingChronic Pain | Chronic Low Back PainUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
Clinical Trials on Standard physical therapy care
-
University of Kansas Medical CenterNot yet recruitingLow Back Pain | Knee Osteoarthritis | Neck PainUnited States
-
University of Missouri-ColumbiaCompletedLow Back Pain | Pelvic Pain | Adhesions | Scar TissueUnited States
-
Lawson Health Research InstituteCompleted
-
Hospital for Special Surgery, New YorkRecruiting
-
University of PittsburghWithdrawnAnterior Cruciate Ligament ReconstructionUnited States
-
James J. IrrgangCompletedTotal Knee ArthroplastyUnited States
-
Khon Kaen UniversityCompletedChronic Nonspecific Low Back PainThailand
-
Aurora Health CareWithdrawnStroke | Parkinson's Disease | Muscle WeaknessUnited States
-
Henry M. Jackson Foundation for the Advancement...United States Naval Medical Center, San Diego; Madigan Army Medical Center; Fort... and other collaboratorsRecruitingInstability; Ankle (Ligaments) (Old Injury) | Sprain of AnkleUnited States
-
NYU Langone HealthRecruiting