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

Primary Purpose

Trust, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
intervention
placebo
Sponsored by
Taoyuan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trust focused on measuring Trust, Low Back Pain, Treatment Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Taoyuan general hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
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)

Secondary Outcome Measures

Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
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
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.

Full Information

First Posted
June 5, 2016
Last Updated
September 24, 2018
Sponsor
Taoyuan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02799628
Brief Title
Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects
Official Title
Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taoyuan General Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trust, Low Back Pain
Keywords
Trust, Low Back Pain, Treatment Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
intervention
Intervention Description
intervention with recommendation and therapist introduction
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
low back pain education, and physical therapy 3 times per week
Primary Outcome Measure Information:
Title
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Time Frame
The first time data collection for individual 5 mins after the intervention.
Title
Success treatment proportion between intervention group and placebo group 4 weeks after intervention
Description
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)
Time Frame
data collection for individual at the 0 and 4th week after clinical visit
Secondary Outcome Measure Information:
Title
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Time Frame
The second time and third time data collection after 2 weeks and 4 weeks after first clinical visit
Title
Change of pain score with The Chinese version of the Brief Pain Inventory (BPI-C) between intervention group and placebo group
Description
Pain score change from baseline
Time Frame
data collection for individual at the0, 2nd and 4th week after clinical visit
Title
Change of the compression force to trigger the tenderness point from baseline
Description
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.
Time Frame
data collection for individual at the 0, 2nd and 4th week after clinical visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huan-Jui Yeh
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taoyuan general hospital
City
Taoyuan
ZIP/Postal Code
33004
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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