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
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
Public
No 155, Li-Nong St
Beitou District
Taipei City
11221
Taiwan
 ORCID ID |
0000-0002-3332-9844 |
|---|
Study information
| Study design | Multicentre interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The efficacy of acupressure to prevent anti-tuberculosis drugs-induced adverse effects in pulmonary tuberculosis patients: a randomised parallel trial |
| Study objectives | Acupressure 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) studied | 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 |
| 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 study start date | 29/04/2015 |
| Completion date | 28/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | Pulmonary tuberculosis patients aged 20 years old or over |
| Key exclusion criteria | Has cancer, severe liver or renal disease, extra-pulmonary TB, and consciousness unclear |
| Date of first enrolment | 29/04/2015 |
| Date of final enrolment | 28/03/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Shipai Road
Beitou District
Taipei City
11217
Taiwan
Sanmin Road
Taichung
40343
Taiwan
Sponsor information
Hospital/treatment centre
No.201, Sec. 2
Shipai Road
Beitou District
Taipei City
11217
Taiwan
"ROR" |
https://ror.org/03ymy8z76 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To 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.
