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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03443401
Enrollment
43
Registered
2018-02-23
Start date
2018-04-08
Completion date
2020-09-24
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain, Physical Therapy, Trust

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.

Interventions

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

Sponsors

Iowa Physical Therapy Foundation
CollaboratorOTHER
University of South Dakota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global Rate of Changethrough study completion, an average of 1 yearGlobal 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.
Change in Trust in Physician Scalethrough study completion, an average of 1 yearMeasurement 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.
Change in Oswestry Disability Index 2.0through study completion, an average of 1 yearMeasurement 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.
Change in Numeric Pain Rating Scalethrough study completion, an average of 1 yearPain 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.
Change in Patient Care Assessment Surveythrough study completion, an average of 1 yearMeasurement 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.
Change in Wake Forest Scalethrough study completion, an average of 1 yearMeasurement 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.

Secondary

MeasureTime frameDescription
Change in Working Alliance Inventory - Short Revisedafter initial visit and discontinuation of services, an average of 4-8 weeks.therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance.
Change in PT Survey of Patient Connection and Engagementafter 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. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement.
General Trust in Physician Scalethrough study completion, an average of 1 yearglobal trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales.

Countries

United States

Participant flow

Participants by arm

ArmCount
Patient Participants
patients with chronic low back pain receiving standard physical therapy care Standard physical therapy care: standard plan of care delivered to patient with chronic low back within scope of licensure
29
Total29

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyInfluential outlier1
Overall StudyLost to Follow-up13

Baseline characteristics

CharacteristicPatient Participants
Age, Continuous49.3 years
STANDARD_DEVIATION 15
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
23 Participants
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
14 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 29
other
Total, other adverse events
0 / 29
serious
Total, serious adverse events
0 / 29

Outcome results

Primary

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.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in Numeric Pain Rating Scale1.1 score on a scaleStandard Deviation 2.6
Primary

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.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in Oswestry Disability Index 2.011.1 score on a scaleStandard Deviation 17.7
Primary

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.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in Patient Care Assessment Survey3.3 score on a scaleStandard Deviation 1.1
Primary

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.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in Trust in Physician Scale5.2 score on a scaleStandard Deviation 0.5
Primary

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.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in Wake Forest Scale4.2 score on a scaleStandard Deviation 1.5
Primary

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.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsGlobal Rate of Change2.3 score on a scaleStandard Deviation 0.5
Secondary

Change in PT Survey of Patient Connection and Engagement

Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement.

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

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in PT Survey of Patient Connection and Engagement0 score on a scaleStandard Deviation 0.5
p-value: 0.027Spearman's rho
Secondary

Change in Working Alliance Inventory - Short Revised

therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance.

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

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsChange in Working Alliance Inventory - Short Revised5.6 score on a scaleStandard Deviation 2.3
p-value: 0.004Spearman's rho
Secondary

General Trust in Physician Scale

global trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales.

Time frame: through study completion, an average of 1 year

ArmMeasureValue (MEAN)Dispersion
Patient ParticipantsGeneral Trust in Physician Scale43.89 score on a scaleStandard Deviation 6.27

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026