UMIN-ICDS Clinical Trial

Public title

Is transcutaneous electrical stimulation effective for postthoracotomy pain?

Acronym

Is transcutaneous electrical stimulation effective for postthoracotomy pain?

Scientific Title

The feasibility study of patient's symptom-synchronized transcutaneous electrical stimulation for postthoracotomy pain.

Scientific Title:Acronym

Patient's symptom-synchronized transcutaneous electrical stimulation for postthoracotomy pain.

Region

Japan

Condition

lung caner, lung infection, mediastinal tumor, pneumothorax

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine whether transcutaneous electrical stimulation (TENS) can be tuned to acute pain in thoracic surgery, as well as to identify trends in visual analogue scale (VAS) when TENS is used.

Basic objectives2

Others

Basic objectives -Others

In the present study, we hypothesized that the use of transcutaneous electrical stimulation tuned to various types of pain in the acute postoperative period of thoracic surgery (in which nociceptive pain and neuropathic pain are mixed) would be a useful solution to "reduce acute postoperative pain and avoid its transition to chronic pain". Therefore, we decided to conduct a pilot study to determine whether this technique could be used to treat symptoms of acute postoperative pain after thoracic surgery.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Acute pain and TENS entrainment after thoracic surgery: If both pain and TENS stimulation are reduced or eliminated, the patient is entrained.

Key secondary outcomes

Evaluating VAS trends in patients treated with TENS for acute pain in thoracic surgery

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patient-symptoms synchronized TENS, before intervention, a procedure is performed to match the symptoms of patient pain with the parameters of electrical stimulation. Specifically, the pulse width is set to 50 ms, the TENS frequency is matched to the fine sensations of patient pain, especially neuropathic pain such as numbness and tingling, at 10 Hz intervals, and the perceived intensity of the symptoms is matched to the TENS stimulus intensity at 1 mA intervals. Feasibility is determined by whether it is possible or impossible to match the subjective symptoms with the TENS stimuli. In this study, ESPURGE was used for TENS. The skin is treated with alcohol on the intercostal nerve innervating the site of the patient's greatest pain (often an open chest wound or chest drain insertion site), and a 50 mm * 50 mm self-adhesive electrode is applied.
Frequency, based on previous studies, 60 minutes once a day, from the date of obtaining consent to the date of discharge (thoracic surgery is currently approximately 5-6 TENS interventions due to approximately one week hospitalization).

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who have undergone surgery for lung cancer, lung infection, mediastinal tumor, or pneumothorax at the Department of Oncology, Nagasaki University
(ii) All open thoracic procedures (conventional thoracotomy, thoracoscopic surgery, robotic-assisted surgery) except for median sternotomy
(iii) Patients who underwent respiratory surgery from the date of study approval to 3/31/2024 and who, despite receiving standard postoperative analgesics (loxoprofen 3 tablets 3/day + acetaminophen (500) 4 tablets 4/day from the day after surgery), had a maximum daily VAS (Visual analogue scale: 0 (no pain at all) to 10 (maximum imaginable pain) > 40 mm.

Key exclusion criteria

(1) Patients who underwent surgery through a median sternotomy
(2) Patients who have been taking some kind of analgesic medication before the surgery
(iii) Patients who have difficulty in transmitting sensation from TENS to the examiner
(4) Patients with heart disease or pacemaker implants
(5) Pregnant women or patients who may become pregnant
(vi) Patients who are participating in clinical trials, other clinical studies, or observational studies
(vii) Other patients who are deemed inappropriate as research subjects by the investigators, etc.

Target sample size

14

Name of lead principal investigator

1st name	Keitaro
Middle name
Last name	Matsumoto

Organization

Nagasaki University Graduate School of Medicine

Division name

Surgical Oncology

Zip code

8528501

Address

1-7-1, Sakamoto, Nagasaki

TEL

0958197304

Email

kmatsumo@nagasaki-u.ac.jp

Name of contact person

1st name	Takuro
Middle name
Last name	Miyazaki

Organization

Nagasaki University Graduate School of Medicine

Division name

Surgical Oncology

Zip code

8528501

Address

1-7-1, Sakamoto, Nagasaki

TEL

0958197304

Homepage URL

Email

miyataku@nagasaki-u.ac.jp

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Department of Surgical Oncology, Nagasaki University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagasaki University Graduate School of Medicine

Address

1-7-1, Sakamoto, Nagasaki

Tel

0958197304

Email

miyataku@nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

10

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

10

Month

16

Day

Date of IRB

2023

Year

10

Month

16

Day

Anticipated trial start date

2023

Year

10

Month

17

Day

Last follow-up date

2024

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

17

Day

Last modified on

2024

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059729