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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799628
• Other study ID #: TYGH104046
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2018
• Source: Taoyuan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Trust

Intervention

Behavioral:
• intervention
intervention with recommendation and therapist introduction

Other:
• placebo
low back pain education, and physical therapy 3 times per week

Locations

Country	Name	City	State
Taiwan	Taoyuan general hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Taoyuan General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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