Trial Outcomes & Findings for Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain (NCT NCT03443401)

NCT ID: NCT03443401

Last Updated: 2024-10-15

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 43 participants
• Primary outcome timeframe: through study completion, an average of 1 year
• Results posted on: 2024-10-15

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	43
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	13
Overall Study Influential outlier	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patient Participants n=29 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
Age, Continuous	49.3 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Participants n=29 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
Change in Patient Care Assessment Survey	3.3 score on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Participants n=29 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
Change in Wake Forest Scale	4.2 score on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Participants n=29 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
Change in Trust in Physician Scale	5.2 score on a scale Standard Deviation .5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Participants n=29 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
Change in Oswestry Disability Index 2.0	11.1 score on a scale Standard Deviation 17.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Participants n=29 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
Change in Numeric Pain Rating Scale	1.1 score on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Participants n=29 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
Global Rate of Change	2.3 score on a scale Standard Deviation .5

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

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.

Outcome measures

Measure	Patient Participants n=29 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
General Trust in Physician Scale	43.89 score on a scale Standard Deviation 6.27

SECONDARY outcome

Timeframe: after 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.

Outcome measures

Measure	Patient Participants n=29 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
Change in Working Alliance Inventory - Short Revised	5.6 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement.

Outcome measures

Measure	Patient Participants n=29 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
Change in PT Survey of Patient Connection and Engagement	0 score on a scale Standard Deviation .5

Adverse Events

Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kory Zimney, PhD

USouthDakota

Phone: 6056586373

Email: kory.zimney@usd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place