NCT03443401

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

Completed Results posted Last updated 15 October 2024

What this trial tests

trial testing Standard physical therapy care in Trust in 43 participants. Completed in 24 September 2020.

Timeline

8 April 2018

Primary endpoint
24 September 2020

24 September 2020

Quick facts

Lead sponsor	University of South Dakota
Status	Completed
Study type	OBSERVATIONAL
Enrollment	43
Start date	8 April 2018
Primary completion	24 September 2020
Estimated completion	24 September 2020
Sites	11 locations across United States

Drugs / interventions tested

• Standard physical therapy care

Conditions studied

• Trust — all drugs for Trust →
• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →
• Physical Therapy — all drugs for Physical Therapy →

Sponsor

University of South Dakota

Who can join

18 and older, any sex, with Trust or Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Patient Care Assessment Survey Primary · 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.

Group	Value	95% CI
Patient Participants	3.3	± 1.1

Change in Wake Forest Scale Primary · 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.

Group	Value	95% CI
Patient Participants	4.2	± 1.5

Change in Trust in Physician Scale Primary · 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.

Group	Value	95% CI
Patient Participants	5.2	± .5

Change in Oswestry Disability Index 2.0 Primary · 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.

Group	Value	95% CI
Patient Participants	11.1	± 17.7

Change in Numeric Pain Rating Scale Primary · 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.

Group	Value	95% CI
Patient Participants	1.1	± 2.6

Global Rate of Change Primary · 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.

Group	Value	95% CI
Patient Participants	2.3	± .5

General Trust in Physician Scale Secondary · 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.

Group	Value	95% CI
Patient Participants	43.89	± 6.27

Change in Working Alliance Inventory - Short Revised Secondary · 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.

Group	Value	95% CI
Patient Participants	5.6	± 2.3

Change in PT Survey of Patient Connection and Engagement Secondary · 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.

Group	Value	95% CI
Patient Participants	0	± .5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.