Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects

The trust between patients and medical providers is the cornerstone to obtain success treatment. To boost the trust can increase medical prescription compliance, enhance patient satisfaction, and improve the effectiveness of treatment. Otherwise, mistrust between medical providers and patients will result in ineffective treatment and excessive defensive health care. This situation may cause medical dispute and medical resources wasting problems.

Most of treatment complete in a few times of admissions and interventions. So, how to improve the trust between patients and doctors quickly became a more knotty problem. Several studies found that speech (including listening, showing compassion, and take longer to explain), reputation, clothing, offer a newer therapy were more important than age, title, and sex.

However, past researches were restricted to an unclear causal relationship. That is they can't be determined whether good doctor-patient relationship and better trust conditions create a longer visit time, better satisfaction, and good reputation, or vice versa. They also unable to clarify whether the high degree of trust result in improved treatment effects, or good relationship result from good medical outcomes.

Investigators want to design a randomized control trial by giving patients recommendation and physical therapist introductions to enhance the trust of patients to therapists. And this study may verify whether enhance trust between therapists and patients will lead to changes in treatment effectiveness.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Trust
• Intervention / Treatment: Behavioral: intervention; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33004
    • TaoYuan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. First time visit to Taoyuan general hospital rehabilitation ward at 2016/07/01~2017/12/31
2. Diagnosis with L spine spondylosis, L spine Herniated Inter-vertebral Disc, or non-acute low back muscle strain
3. Suitable for physical therapy with ( Hot packing + interference current therapy + pelvic traction + therapeutic exercise )
4. most pain score >2

Exclusion Criteria:

1. poor of follow oral order, or patients who can't understand Chinese, including patients with aphasia or dementia
2. patient who can not received 4 weeks of physical therapy
3. other cause of low back pain which can't treatment with physical therapy, including : (Urinary tract stones, infection, rapid progression disease which need immediately operation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention; Give the physical therapy of low back pain educational video + therapist introduction and recommendation video, at the first time of clinic visit.; Physical therapy with hot packing + interference current therapy + pelvic traction + therapeutic exercise, 3 times per week for 4 weeks.	Behavioral: intervention; intervention with recommendation and therapist introduction; Other: placebo; low back pain education, and physical therapy 3 times per week
Placebo Comparator: placebo; Give the physical therapy of low back pain educational video, at the first time of clinic visit.; Physical therapy with hot packing + interference current therapy + pelvic traction + therapeutic exercise, 3 times per week for 4 weeks.	Other: placebo; low back pain education, and physical therapy 3 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group		The first time data collection for individual 5 mins after the intervention.
Success treatment proportion between intervention group and placebo group 4 weeks after intervention	Success treatment is defined as the most pain score decrease from baseline more than 2 degree. ( Pain score change from baseline by Visual Analogue Scale after 4 weeks)	data collection for individual at the 0 and 4th week after clinical visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group		The second time and third time data collection after 2 weeks and 4 weeks after first clinical visit
Change of pain score with The Chinese version of the Brief Pain Inventory (BPI-C) between intervention group and placebo group	Pain score change from baseline	data collection for individual at the0, 2nd and 4th week after clinical visit
Change of the compression force to trigger the tenderness point from baseline	The compression force was measured by IMADA digital force gauge (kgf) In each data collection point(0 , 2nd and 4th week) , we arrange 3 times test and use the average as the measure value.	data collection for individual at the 0, 2nd and 4th week after clinical visit

Collaborators and Investigators

• Sponsor: Taoyuan General Hospital
• Investigators: Principal Investigator: Huan-Jui Yeh, Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: June 5, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Low Back Pain; Treatment Outcome; Trust
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: TYGH104046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO