Condition category
Infections and Infestations
Date applied
29/04/2015
Date assigned
02/05/2015
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pulmonary tuberculosis (TB) is a curable bacterial infection that affects the lungs. With the development of a standard six-month drug treatment, the focus of TB management has shifted from controlling and curing the disease to increasing the quality of life of patients. However, many patients have adverse drug reactions during treatment, which can affect patients’ quality of life and result in failure to complete treatment. Acupressure has been used to treat adverse drug reactions, but further evidence is needed. Therefore, the aim of this study is to find out whether acupressure prevents adverse drug reactions to anti-tuberculosis drugs in pulmonary TB patients.

Who can participate?
Pulmonary tuberculosis patients aged 20 or over.

What does the study involve?
Participants will be randomly allocated to either the experimental group or the control group. All participants undergo an acupressure program for 15 minutes per day, five days per week, for four weeks. Acupressure practitioners use their fingers, palms, elbows or feet, or special devices to apply pressure to specific points on the body (acupoints). The experimental group are treated with acupressure on effective acupoints, while the control group are treated with acupressure on non-effective acupoints.

What are the possible benefits and risks of participating?
The possible benefits of participating will be prevention of adverse drug reactions. The risks of participating will be redness and mild pain at the skin after acupressure.

Where is the study run from?
Taipei Veterans General Hospital and Taichung Hospital, Ministry of Health and Welfare (Taiwan).

When is the study starting and how long is it expected to run for?
From April 2015 to March 2016.

Who is funding the study?
Investigator initiated and funded.

Who is the main contact?
Chia-Ju Hsieh

Trial website

Contact information

Type

Public

Primary contact

Doctoral student Chia-Ju Hsieh

ORCID ID

http://orcid.org/0000-0002-3332-9844

Contact details

No 155
Li-Nong St
Beitou District
Taipei City
11221
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The efficacy of acupressure to prevent anti-tuberculosis drugs-induced adverse effects in pulmonary tuberculosis patients: a randomised parallel trial

Acronym

Study hypothesis

Acupressure can prevent anti-tuberculosis drug-induced adverse effects in pulmonary tuberculosis patients

Ethics approval

Institutional Review Board, Taipei Veterans General Hospital

Study design

Multicentre interventional trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pulmonary tuberculosis

Intervention

Participants are randomized to the experimental and control groups. All participants undergo an acupressure program for 15 minutes per day, five days per week, for four weeks. The experimental group are treated with acupressure on correct and efficacious acupoints, while the control group are treated with acupressure on correct and non-efficacious acupoints.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Adverse drug effects; the research assistant will collect the data from patients’ self-report, like the type, frequency and severity of adverse drug effects
2. Physiological changes
3. Patient’s adherence, using their medical charts
All outcomes will be measured at baseline, and every month until they complete their treatment

Secondary outcome measures

1. Health-related quality of life, using the Short-Form-36 Health Survey
2. Cure rate, using medical charts
All outcomes will be measured at baseline, and every month until they completed their treatment

Overall trial start date

29/04/2015

Overall trial end date

28/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Pulmonary tuberculosis patients aged 20 years old or over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

Has cancer, severe liver or renal disease, extra-pulmonary TB, and consciousness unclear

Recruitment start date

29/04/2015

Recruitment end date

28/03/2016

Locations

Countries of recruitment

Taiwan

Trial participating centre

Taipei Veterans General Hospital
No.201, Sec. 2 Shipai Road Beitou District
Taipei City
11217
Taiwan

Trial participating centre

Taichung Hospital, Ministry of Health and Welfare
199, sec. 1 Sanmin Road
Taichung
40343
Taiwan

Sponsor information

Organisation

Taipei Veterans General Hospital

Sponsor details

No.201
Sec. 2
Shipai Road
Beitou District
Taipei City
11217
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes