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Effects of Transcutaneous Nerve Electrostimulation (TENS) of Acupuncture Points on Pulmonary Function and Dyspnea Symptoms in Patients With Pulmonary Nodules (LUNG TENS)

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ClinicalTrials.gov Identifier: NCT04051398
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Igor Renato Louro Bruno de Abreu, Hospital Santa Marcelina

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lung Diseases Dyspnea Acupuncture Other: transcutaneous nerve electrostimulation (TENS) of acupuncture points Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: . 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.
Primary Purpose: Treatment
Official Title: Effects of Transcutaneous Nerve Electrostimulation (TENS) of Acupuncture Points on Pulmonary Function and Dyspnea Symptoms in Patients With Pulmonary Nodules Treated at a Referral Service: A Randomized Single Blind Study
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm (BI)
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
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.
Other Name: TENS Acupuncture

Placebo Comparator: Control Arm (BC)
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.
Other Name: TENS Acupuncture




Primary Outcome Measures :
  1. Evaluate the immediate effects of this procedure on forced expiratory volume in one second (FEV1). [ Time Frame: 45 minutes after the beginning of intervention of each participant. ]
    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

  2. Evaluate the immediate effects of this procedure on forced vital capacity (FVC). [ Time Frame: 45 minutes after the beginning of intervention of each participant. ]
    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

  3. Evaluate the immediate effects of this procedure on VEF1/FVC ratio. [ Time Frame: 45 minutes after the beginning of intervention of each participant. ]
    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

  4. Evaluate the immediate effects of this procedure on 6 - minute Walk Test. [ Time Frame: 45 minutes after the beginning of intervention of each participant. ]
    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

  5. Evaluate the effects of TENS on dyspnea symptoms. [ Time Frame: 45 minutes after the beginning of intervention of each participant. ]
    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.


Secondary Outcome Measures :
  1. Evaluate the effects of TENS on blood oxygen saturation. [ Time Frame: 45 minutes after the beginning of intervention of each participant. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • smokers
  • patients with pulmonary nodules attended at Santa Marcelina Hospital.

Exclusion Criteria:

  • Patients with pacemakers
  • patients unable to read, understand and sign the informed consent form
  • patients with mobility restrictions
  • patients with chest pain
  • patients who have previously used TENS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051398


Locations
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Brazil
Ambulatório de Nódulos e Massas Pulmonares H Santa Marcelina Recruiting
São Paulo, SP, Brazil, 08270070
Contact: Igor Renato LB Abreu, MD    55(11) 20706000    torax.santa.marcelina@gmail.com   
Sponsors and Collaborators
Hospital Santa Marcelina

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Igor Renato Louro Bruno de Abreu, Medical Staff of Thoracic Surgery Department of Santa Marcelina Hospital, Hospital Santa Marcelina
ClinicalTrials.gov Identifier: NCT04051398     History of Changes
Other Study ID Numbers: Santa Marcelina Hospital
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Igor Renato Louro Bruno de Abreu, Hospital Santa Marcelina:
Acupuncture
Lung

Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Diseases
Dyspnea
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms