Chronic Obstructive Pulmonary Disease (COPD)NCT00971490
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
A study testing Acu-TENS (Transcutaneous electrical nerve stimulation) in people with Chronic Obstructive Pulmonary Disease (COPD), run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Acu-TENS (Transcutaneous electrical nerve stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Dec 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis with COPD
Who cannot join
- allergic to gel
- unable to perform spirometry
- unable to communicate
- no history of infection or exacerbation of respiratory symptoms
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD.
- Being tested
- Acu-TENS (Transcutaneous electrical nerve stimulation)
- Keywords
- COPD, FEV1, beta endorphin, SGRQ, Acu-TENS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acu-TENS (Transcutaneous electrical nerve stimulation)Device
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Acu-TENS (Transcutaneous electrical nerve stimulation)Device
Similar to Group 1 but without electrical stimulation
Acu-TENS (Transcutaneous electrical nerve stimulation)Device
Similar to Group 1 but applied onto non acupuncture point
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Device: Acu-TENS (Transcutaneous electrical nerve stimulation) |
| Group 2 | Placebo comparator | Not described Receives: Device: Acu-TENS (Transcutaneous electrical nerve stimulation) |
| Group 3 | Sham comparator | Not described Receives: Device: Acu-TENS (Transcutaneous electrical nerve stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Measured: measured before and after the 4-week program
Secondary outcomes (1)
beta endorphin, St George Respiratory Questionnaire (SGRQ)
Measured: measured before and after the 4-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971490
- Sponsor's protocol ID
- CRE-2007.158-T
- Status last verified
- Sep 2009
- First submitted
- 28 Jul 2009
- Last updated
- 3 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00971490
- Acronym / sponsor ID
- CRE-2007.158-T
- Keywords
- COPD, FEV1, beta endorphin, SGRQ, Acu-TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Sep 2009 (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 objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Acu-TENS (Transcutaneous electrical nerve stimulation) |
| Group 2 | Placebo comparator | Device: Acu-TENS (Transcutaneous electrical nerve stimulation) |
| Group 3 | Sham comparator | Device: Acu-TENS (Transcutaneous electrical nerve stimulation) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis with COPD
Key exclusion criteria (4 listed)
- allergic to gel
- unable to perform spirometry
- unable to communicate
- no history of infection or exacerbation of respiratory symptoms
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 |
|---|---|---|
| Acu-TENS (Transcutaneous electrical nerve stimulation)Transcutaneous electrical nerve stimulation applied onto acupuncture point | Device | Group 1 |
| Acu-TENS (Transcutaneous electrical nerve stimulation)Similar to Group 1 but without electrical stimulation | Device | Group 2 |
| Acu-TENS (Transcutaneous electrical nerve stimulation)Similar to Group 1 but applied onto non acupuncture point | Device | Group 3 |
Primary outcome
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Time frame: measured before and after the 4-week program
1 secondary outcome
beta endorphin, St George Respiratory Questionnaire (SGRQ)
Time frame: measured before and after the 4-week program
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 3 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acu-TENS (Transcutaneous electrical nerve stimulation) in people with Chronic Obstructive Pulmonary Disease (COPD), run by The Hong Kong Polytechnic University at 1 site in China.
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 1 inclusion and 4 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 3 Sep 2009. 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 China. 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?
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) (time frame: measured before and after the 4-week program). 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 3 Sep 2009.