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

NCT04051398 | Unknown

• 1 other identifier: Santa Marcelina Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Dyspnea; Acupuncture

Keywords

Acupuncture; Lung

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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.

  45 minutes after the beginning of intervention of each participant.

Secondary Outcomes (1)

• Evaluate the effects of TENS on blood oxygen saturation.

  45 minutes after the beginning of intervention of each participant.

Study Arms (2)

Intervention Arm (BI)

EXPERIMENTAL

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

Control Arm (BC)

PLACEBO COMPARATOR

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

Interventions

transcutaneous nerve electrostimulation (TENS) of acupuncture points OTHER

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

Control Arm (BC); Intervention Arm (BI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Santa Marcelina: lead

Study Sites (1)

Ambulatório de Nódulos e Massas Pulmonares H Santa Marcelina

São Paulo, São Paulo, 08270070, Brazil

RECRUITING

Related Publications (6)

• Liu L, Chen S, Zeng D, Li H, Shi C, Zhang L. Cerebral activation effects of acupuncture at Yanglinquan(GB34) point acquired using resting-state fMRI. Comput Med Imaging Graph. 2018 Jul;67:55-58. doi: 10.1016/j.compmedimag.2018.04.004. Epub 2018 Apr 21.

  PMID: 29800886 BACKGROUND

• Xing X, Wang Y, Cui L, Liang Y. [Professor GAO Yuchun's understandings of "treating spirit" and "acupuncture reinforcing and reducing" in Inner Canon of Yellow Emperor and clinical experience]. Zhongguo Zhen Jiu. 2017 Feb 12;37(2):195-198. doi: 10.13703/j.0255-2930.2017.02.026. Chinese.

  PMID: 29231486 BACKGROUND

• Suzuki M, Muro S, Ando Y, Omori T, Shiota T, Endo K, Sato S, Aihara K, Matsumoto M, Suzuki S, Itotani R, Ishitoko M, Hara Y, Takemura M, Ueda T, Kagioka H, Hirabayashi M, Fukui M, Mishima M. A randomized, placebo-controlled trial of acupuncture in patients with chronic obstructive pulmonary disease (COPD): the COPD-acupuncture trial (CAT). Arch Intern Med. 2012 Jun 11;172(11):878-86. doi: 10.1001/archinternmed.2012.1233.

  PMID: 22905352 RESULT

• Mehani SHM. Immunomodulatory effects of two different physical therapy modalities in patients with chronic obstructive pulmonary disease. J Phys Ther Sci. 2017 Sep;29(9):1527-1533. doi: 10.1589/jpts.29.1527. Epub 2017 Sep 15.

  PMID: 28931981 RESULT

• Johnson M. Transcutaneous Electrical Nerve Stimulation: Mechanisms, Clinical Application and Evidence. Rev Pain. 2007 Aug;1(1):7-11. doi: 10.1177/204946370700100103.

  PMID: 26526976 RESULT

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

Related Links

• Borg Scale

MeSH Terms

Conditions

Lung Diseases; Dyspnea

Interventions

Transcutaneous Electric Nerve Stimulation; Acupuncture Points

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Meridians; Acupuncture Therapy; Complementary Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: . 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff of Thoracic Surgery Department of Santa Marcelina Hospital

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: August 6, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 31, 2023
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)