Chronic Obstructive Pulmonary Disease (COPD)NCT00922051
Acute Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Forced Expiratory Flow Volume in One Second (FEV1) and Blood β-Endorphin Level in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Chronic Obstructive Pulmonary Disease (COPD), run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and its association with beta endorphin level in subjects with COPD. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Sep 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 45 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Acu-TENS on FEV1 and Blood β-Endorphin Level in Subjects With COPD
The objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and its association with beta endorphin level in subjects with COPD.
- Being tested
- Transcutaneous electrical nerve stimulation (TENS)
- Keywords
- COPD, FEV1, beta endorphin, TENS, acupuncture
- 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.
Transcutaneous electrical nerve stimulation (TENS)Device
Transcutaneous electrical nerve stimulation (TENS)Device
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Application of Acu-TENS Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Group 2 | Placebo comparator | Not described Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC)
Measured: measured before and after intervention
Secondary outcomes (1)
Beta endorphin
Measured: before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionSep 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Investigators
- Alice Jones, PhD, FACP, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922051
- Sponsor's protocol ID
- HSEARS20070305001
- Status last verified
- Jun 2009
- First submitted
- 16 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Acu-TENS on FEV1 and Blood β-Endorphin Level in Subjects With COPD
- ClinicalTrials.gov ID
- NCT00922051
- Acronym / sponsor ID
- HSEARS20070305001
- Keywords
- COPD, FEV1, beta endorphin, TENS, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Jun 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 objective of this study is to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions, dyspnoeic symptoms and its association with beta endorphin level 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Application of Acu-TENS |
| Group 2 | Placebo comparator | Device: Transcutaneous electrical nerve stimulation (TENS) |
Who may qualify
- Ages
- 45 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 (3 listed)
- allergic to gel
- unable to perform spirometry
- unable to communicate
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Device | Group 1 |
| Transcutaneous electrical nerve stimulation (TENS)Placebo | Device | Group 2 |
Primary outcome
Forced expiratory flow volume in one second (FEV1), forced vital capacity (FVC)
Time frame: measured before and after intervention
1 secondary outcome
Beta endorphin
Time frame: before and after intervention
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 17 Jun 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.
Alice Jones, PhD, FACP principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) 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 3 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 17 Jun 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 flow volume in one second (FEV1), forced vital capacity (FVC) (time frame: measured before and after intervention). 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 17 Jun 2009.