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

Sponsor

Taoyuan General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02799628

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Trust Low Back Pain	Behavioral: intervention Other: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 [data collection for individual at the 0 and 4th week after clinical visit]
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)

Secondary Outcome Measures

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 [data collection for individual at the0, 2nd and 4th week after clinical visit]
Pain score change from baseline
Change of the compression force to trigger the tenderness point from baseline [data collection for individual at the 0, 2nd and 4th week after clinical visit]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

poor of follow oral order, or patients who can't understand Chinese, including patients with aphasia or dementia
patient who can not received 4 weeks of physical therapy
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taoyuan general hospital	Taoyuan		Taiwan	33004

Sponsors and Collaborators

Taoyuan General Hospital

Investigators

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