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

NCT02799628 | Completed

• 1 other identifier: TYGH104046
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Trust; Low Back Pain

Keywords

Trust; Low Back Pain; Treatment Outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• 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

Study Arms (2)

intervention

ACTIVE COMPARATOR

1. Give the physical therapy of low back pain educational video + therapist introduction and recommendation video, at the first time of clinic visit. 2. Physical therapy with hot packing + interference current therapy + pelvic traction + therapeutic exercise, 3 times per week for 4 weeks.

Behavioral: intervention; Other: placebo

placebo

PLACEBO COMPARATOR

1. Give the physical therapy of low back pain educational video, at the first time of clinic visit. 2. Physical therapy with hot packing + interference current therapy + pelvic traction + therapeutic exercise, 3 times per week for 4 weeks.

Other: placebo

Interventions

intervention BEHAVIORAL

intervention with recommendation and therapist introduction

intervention

placebo OTHER

low back pain education, and physical therapy 3 times per week

intervention; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taoyuan General Hospital: lead

Study Sites (1)

Taoyuan general hospital

Taoyuan District, 33004, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Huan-Jui Yeh

  Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: June 15, 2016
• Study Start: July 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: September 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)