UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052521 |
|---|---|
| Receipt number | R000059729 |
| Scientific Title | The feasibility study of patient's symptom-synchronized transcutaneous electrical stimulation for postthoracotomy pain. |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2024/10/17 14:56:00 |
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Basic information
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
Condition
lung caner, lung infection, mediastinal tumor, pneumothorax
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
kmatsumo@nagasaki-u.ac.jp
Public contact
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
miyataku@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgical Oncology, Nagasaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School of Medicine
Address
1-7-1, Sakamoto, Nagasaki
Tel
0958197304
miyataku@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059729
