An interventional study of transcutaneous nerve electrostimulation (TENS) of acupuncture points in Lung Diseases, Dyspnea and Acupuncture, sponsored by Hospital Santa Marcelina. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Hospital Santa Marcelina · Not applicable, Interventional, and Treatment
The ancient use of acupuncture as a treatment modality of traditional Chinese medicine has also been proven effective in Western medicine. The use of this treatment tool for pain control is already proven in the literature and today is considered an important adjuvant for this purpose. However, the ancient texts of acupuncture also report the use of certain points to tonify organs functions, despite of pain control. According to these texts there are some points that allow the treatment of lung diseases improving respiratory function.
In order to investigate the effects of stimulation of such points using electric field application, the effect of these procedure on pulmonary function and the impact of this practice on dyspnea symptoms, the investigators will conduct a randomized study with 60 patients (1: 1 randomization) distributed in 2 arms (intervention arm-BI and control arm-BC). Transcutaneous neural stimulation of acupuncture points of the BI patients will be performed. For the BC arm the investigators will place the electrodes over the points without turn on the device to produce a placebo effect. Pulmonary function test, Borg scale application and 6 min walk test will be performed before and after the intervention in each group for subsequent data comparison.
Introduction:
The use of acupuncture for pain management is well defined and fully established. The stimulation of acupuncture points using needles, electrical stimuli, thermal or laser stimuli produce local effects at the point (nociceptor stimulation and release of inflammatory mediators) that generate systemic effects (serotonin release and endorphins in the Central Nervous System). leading to the state of body relaxation, well-being, changes in heart rate, blood pressure and analgesia.
However, acupuncture can trigger other effects beyond pain control. In ancient texts dealing with the subject there are descriptions of points capable of promoting improvement of specific organic functions such as pulmonary function. 2 This effect is due to changes generated by the action of acupuncture on the autonomic nervous system promoting bronchodilation and decreased mucus production. Some studies of effects of acupuncture in patients with chronic obstructive pulmonary disease have shown promising results related to improved lung function and reduced symptoms.
Transcutaneous nerve electrostimulation (TENS) can be used to stimulate acupuncture points as an alternative to needles. This modality of stimulation prevents the occurrence of serious complications such as pneumothorax secondary to needle application to thoracic points. This practice turns the procedure safer allowing any trainned healthcare professional to do it.
Goals:
Materials and methods:
Will be recruited 60 participants over the age of 18 years, smokers and patients with pulmonary nodules attended at Santa Marcelina Hospital. Patients with pacemakers, patients unable to read, understand and sign the informed consent form, with mobility restrictions, chest pain and patients who have previously used TENS will be excluded from this study.
Participants will be randomized in a 1/1 ratio to form 2 arms: intervention arm (BI) and control arm (BC).
The BI participants will initially undergo simple spirometry and a 6-minute walk test and Borg scale application (this texts are detailed at "Tests Description" item at the end of this manuscript) upon admission to the thoracic surgery department. Immediately after the exams, they will undergo to a TENS application session over the acupuncture points: Feishu, Zhongfu, Taiyuan and Dingchuan using a frequency of 200Hz and a pulse time of 80 seconds of sufficient intensity to cause a slight sensation of local numbness without muscle fasciculations. The TENS application time will be 30 minutes. Immediately after the TENS application, the participants will be submitted to a new spirometry, a new 6-minute walk test and again to the Borg scale evaluation.
The BC participants will undergo to the same steps as BI, however when applying TENS to these participants the investigators will place the electrodes over the points without turning on the device in order to obtain the effect of a placebo. To minimize the impact of non-blinding investigators, will be designated a specific investigator who will be responsible for randomizing participants at the time of TENS application and performing the intervention do not allowing the investigators responsible for data collection know whether the patient will be BI or BC. After data collection, the same investigator will segregate the information from BC and BI keeping the subgroups identification in secret do not allowing the investigator who will perform the statistical analysis know what are the groups. Once the data analysis is ready, the investigator responsible for randomization will tell the other investigators which subgroup corresponds to each arm.
Tests Description:
# 6-minute Walk Test (6 MWT):
In 2002, the American Thoracic Society (ATS) published guidelines on how to perform the 6 MWT. This guideline stressed the need for a standardized protocol to perform the 6 MWT to minimize variation in results.
Although the 6 MWT is very safe, emergency equipment should be at hand. The test should be conducted by personnel qualified to use this equipment. Physicians are not required to be present in most situations, but should be readily available. The physician ordering the test may decide if a physician should supervise the test.
According to ATS guidelines, a 30 meters distance course is recommended. Turnaround points should be identified. Three-meter interval measurements are marked with colored tape on the floor. Shorter corridor lengths may increase the 6 MWD due to more frequent turns involved.
Required equipment
The 6 MWT is performed on a walking track in hospital facility. The track has been marked at 3-m intervals so that accurate measurement of the walking distance can be performed. Chairs are available at 30-m intervals in case the patients become so symptomatic that have to stop and sit.
Patient preparation
Technique
Additional details about technique
Quality control and standardization are important to reduce variability in measurement. Persons supervising the test should be trained using a standard protocol, and should conduct supervised 6 MWTs before patients are able to perform them independently. A practice test generally should not be needed. If a practice test is done, there should be a wait time of about an hour between the two tests, and the longer 6 MWD should be reported.
The scale allows individuals to subjectively rate their level of exertion during exercise or exercise testing.
It is a gradual scale that varies from zero (no fatigue symptoms) to ten (maximum fatigue like the sensation of the hardest race that the participant have ever did)
Patients with higher values on Borg scale evaluation are considered worse.
see the link of Borg scale at the references.
3,319 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 2,122 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Hospital Santa Marcelina is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The BI participants will initially undergo simple spirometry and a 6-minute walk test and Borg scale application upon admission to the thoracic surgery department. Immediately after the exams, they will undergo a TENS application session over the acupuncture points: Feishu, Zhongfu, Taiyuan and Dingchuan using a frequency of 200Hz and a pulse time of 80 seconds of sufficient intensity to cause a slight sensation of local numbness without muscle fasciculations. The TENS application time will be 30 minutes. Immediately after the TENS application, the participants will be submitted to a new spirometry, a new 6-minute walk test and again to the Borg scale.
Other: transcutaneous nerve electrostimulation (TENS) of acupuncture points
The BC participants will undergo the same steps as BI, however when applying TENS to these participants investigators will place the electrodes over the points without turning on the device in order to obtain the effect of a placebo.
Other: transcutaneous nerve electrostimulation (TENS) of acupuncture points
TENS application session over the acupuncture points: Feishu, Zhongfu, Taiyuan and Dingchuan using a frequency of 200Hz and a pulse time of 80 seconds of sufficient intensity to cause a slight sensation of local numbness without muscle fasciculations. The TENS application time will be 30 minutes.
Also known as: TENS Acupuncture
Evaluate the immediate effects of this procedure on forced expiratory volume in one second (FEV1).
To evaluate this outcome the investigators will access the forced expiratory volume in one second (FEV1) values from the spirometry prior to intervention and post intervention spirometry to compare if there are diferences in these values after the TENS application or placebo according to the subgroup of each participant
Time frame: 45 minutes after the beginning of intervention of each participant.
Evaluate the immediate effects of this procedure on forced vital capacity (FVC).
To evaluate this outcome the investigators will access the forced vital capacity (FVC) values from the spirometry prior to intervention and post intervention spirometry to compare if there are diferences in these values after the TENS application or placebo according to the subgroup of each participant
Time frame: 45 minutes after the beginning of intervention of each participant.
Evaluate the immediate effects of this procedure on VEF1/FVC ratio.
To evaluate this outcome the investigators will access the VEF1/FVC ratio values from the spirometry prior to intervention and post intervention spirometry to compare if there are diferences in these values after the TENS application or placebo according to the subgroup of each participant
Time frame: 45 minutes after the beginning of intervention of each participant.
Evaluate the immediate effects of this procedure on 6 - minute Walk Test.
To evaluate this outcome the investigators will access the 6 minutes Walk Test distance values prior to intervention and post intervention to compare if there are diferences in these values after the TENS application or placebo according to the subgroup of each participant
Time frame: 45 minutes after the beginning of intervention of each participant.
Evaluate the effects of TENS on dyspnea symptoms.
The investigators will compare the Borg scale measures prior and after the intervention to access if the were changes in dyspnea symptoms for each participant from each arm.
Time frame: 45 minutes after the beginning of intervention of each participant.
Evaluate the effects of TENS on blood oxygen saturation.
The investigators will compare the blood oxygen saturation using the pulse oximetry measures prior and after the intervention to access if the were changes in dyspnea symptoms for each participant from each arm.
Time frame: 45 minutes after the beginning of intervention of each participant.
Plan to share: No
Started Aug 2019 (actual). Primary completion is estimated for Sep 2021, 24 months after the start.
Of 458 non-industry interventional studies with no phase under Lung Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 24 months is above that.
Counting every sponsor, half of 489 studies reached it within 21 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Santa Marcelina