The efficacy of acupressure to prevent anti-tuberculosis drugs-induced adverse effects in pulmonary tuberculosis patients

ISRCTN ISRCTN93554714
DOI https://doi.org/10.1186/ISRCTN93554714
Secondary identifying numbers N/A
Submission date
29/04/2015
Registration date
02/05/2015
Last edited
31/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Chia-Ju Hsieh
Public

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

ORCiD logoORCID ID 0000-0002-3332-9844

Study information

Study designMulticentre interventional trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Home
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe efficacy of acupressure to prevent anti-tuberculosis drugs-induced adverse effects in pulmonary tuberculosis patients: a randomised parallel trial
Study objectivesAcupressure can prevent anti-tuberculosis drug-induced adverse effects in pulmonary tuberculosis patients
Ethics approval(s)Institutional Review Board, Taipei Veterans General Hospital
Health condition(s) or problem(s) studiedPulmonary tuberculosis
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date29/04/2015
Completion date28/06/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants130
Key inclusion criteriaPulmonary tuberculosis patients aged 20 years old or over
Key exclusion criteriaHas cancer, severe liver or renal disease, extra-pulmonary TB, and consciousness unclear
Date of first enrolment29/04/2015
Date of final enrolment28/03/2016

Locations

Countries of recruitment

  • Taiwan

Study participating centres

Taipei Veterans General Hospital
No.201, Sec. 2
Shipai Road
Beitou District
Taipei City
11217
Taiwan
Taichung Hospital, Ministry of Health and Welfare
199, sec. 1
Sanmin Road
Taichung
40343
Taiwan

Sponsor information

Taipei Veterans General Hospital
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/03ymy8z76

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2019 31/01/2019 Yes No

Editorial Notes

31/01/2019: Publication reference added
06/03/2017: Trial end date was changed from 28/03/2016 to 28/06/2016.