TrustNCT02799628
Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects
A study testing intervention in people with Trust and Low Back Pain, run by Taoyuan General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trust, Low Back Pain
- What is being tested?
- intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- intervention, placebo
- Keywords
- Trust, Low Back Pain, Treatment Outcome
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionBehavioural
intervention with recommendation and therapist introduction
placeboOther
low back pain education, and physical therapy 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: data collection for individual at the 0, 2nd and 4th week after clinical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrustStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Huan-Jui Yeh, Principal investigator, Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799628
- Sponsor's protocol ID
- TYGH104046
- Status last verified
- Sep 2018
- First submitted
- 5 Jun 2016
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects
- ClinicalTrials.gov ID
- NCT02799628
- Acronym / sponsor ID
- TYGH104046
- Conditions
- Trust, Low Back Pain
- Keywords
- Trust, Low Back Pain, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- Jul 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Behavioral: intervention, Other: placebo1. 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. |
| placebo | Placebo comparator | Other: placebo1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interventionintervention with recommendation and therapist introduction | Behavioural | intervention |
| placebolow back pain education, and physical therapy 3 times per week | Other | intervention, placebo |
Primary outcome
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.
Success treatment proportion between intervention group and placebo group 4 weeks after intervention
Time frame: 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)
3 secondary outcomes
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
Change of pain score with The Chinese version of the Brief Pain Inventory (BPI-C) between intervention group and placebo group
Time frame: 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
Time frame: data collection for individual at the 0, 2nd and 4th week after clinical visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huan-Jui Yeh principal investigator
Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention in people with Trust and Low Back Pain, run by Taoyuan General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.