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
Prof 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 measure
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
28/06/2016
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30375013 (added 31/01/2019)