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

Study Overview
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Brief Summary
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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.

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

Conditions
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Trust, Low Back Pain

Intervention / Treatment
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* Behavioral: intervention
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>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<br>* intervention with recommendation and therapist introduction<br>Other: placebo<br>* low back pain education, and physical therapy 3 times per week<br>|
| Placebo Comparator: placebo<br>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<br>* low back pain education, and physical therapy 3 times per week<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trust, Low Back Pain, Treatment Outcome