Condition category
Surgery
Date applied
07/12/2020
Date assigned
13/01/2021
Last edited
13/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Pain after surgery is one of the biggest concerns of both patients and surgeons. Despite many publications, consensuses, and guidelines, the clinical reality is far from perfect. It is reported that up to 50% of patients claim that after surgery the pain relief was insufficient. The aim of this study is to assess the effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) for the treatment of patients after thyroidectomy (removal of the thyroid gland) compared with a sham treatment group and a no-treatment group.

Who can participate?
Patients aged 18–75 undergoing elective thyroidectomy

What does the study involve?
Participants are randomly allocated to one of three groups. The intervention group receives complementary TEAS in addition to drug treatment (morphine through a patient-controlled analgesia [PCA] device). The electrostimulation begins immediately after surgery. The TEAS group will receive stimulation for 30 minutes at intervals of 2 hours. The treatment will automatically stop at the end of each 30-minute treatment interval. The sham group will be equipped with fake devices, which appear exactly like TEAS with the "in use" light flashing regularly. The participants will be forewarned that they may not sense the electrical stimulation. The control group receives only PCA treatment after surgery. Patients will be asked a series of questions about their quality of life at the start and end of the study. Both PCA and TEAS/sham treatment will be stopped 24 hours after the surgery.

What are the possible benefits and risks?
Participants may benefit from receiving non-invasive and relatively safe treatment. The risks and side effects that may arise during the study are mild discomfort at the stimulator's location or rash-like skin irritation.

Where is the study run from?
Wroclaw University Hospital (Poland)

When is the study starting and how long is it run for?
September 2017 to March 2022

Who is funding the study?
Ministry of Science and Higher Education (Poland)

Who is the main contact?
1. Mateusz Szmit, MD
mateusz.szmit@umed.wroc.pl
2. Siddarth Agrawal, MD, PhD
siddarth.agrawal@umed.wroc.pl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mateusz Szmit

ORCID ID

Contact details

Borowska 213
Wroclaw
50-556
Poland
+48 (0)71 736 30 00
mateusz.szmit@umed.wroc.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

0105/DIA/2017/46

Study information

Scientific title

Analgesic effect of transcutaneous electrical acupoint stimulation in patients undergoing thyroidectomy

Acronym

TEASTh

Study hypothesis

1. Transcutaneous electrical acupoint stimulation is more effective at reducing postoperative opioid consumption in patients undergoing thyroidectomy, compared to standard and sham treatment.
2. Transcutaneous electrical acupoint stimulation is effective at decreasing pain intensity in patients undergoing thyroidectomy, compared to standard and sham treatment.
3. Transcutaneous electrical acupoint stimulation is effective at decreasing the frequency of complications in patients undergoing thyroidectomy, compared to standard and sham treatment.

Ethics approval

Approved 21/09/2017, Bioethics Committee - Wroclaw Medical University (50-367 Wrocław, Pasteura 1 St., Poland; +48 (0)71 784 10 14, 71 784 17 10; bioetyka@umed.wroc.pl), ref: KB 599/2017

Study design

Single-center single-blinded placebo-controlled interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Pain and opioid consumption after surgery

Intervention

Enrolled participants will be randomly assigned to TEAS, sham, or a control group (1:1:1). An independent, blinded statistician will generate the block randomization scheme. The table will be managed by an independent researcher who is not involved in the recruitment, treatment, or assessment. The participants will be blinded to the type of treatment.

Upon arrival to the postoperative care unit, the patient will be equipped with a Patient Controlled Analgesia (PCA) device, programmed to deliver 1 mg bolus doses of morphine "on-demand" i.v. with a minimal lockout interval of 10 min and a maximum 4 h dose of 15 mg on the authority of standardized hospital protocol. PCA therapy will be initiated in the postanesthesia care unit as soon as the patient will be sufficiently alert to wield the controller, as the principles of the therapy will be explained before the surgery. If the patient requires pain medication prior to starting PCA therapy, an incremental dose of metamizole 1 g intravenously, will be administered by the postoperative care unit nursing staff. Alongside PCA, analgesic therapy will be supplemented with TEAS/sham therapy, which will begin when the patient arrives at the postoperative care unit.

Stimulation will be carried out using four wireless small electro-stimulators (StimulAid Inc, Poland). A point-detection function in the device will confirm the correct localization of the stimulator. The TEAS group will receive mixed frequency stimulation (alternating at 2 and 100 Hz every 3 s) in continuous mode for 30 min at intervals of 2 h. The device will automatically shut off at the end of each 30 min treatment interval. The strength of the stimulation will be adjusted to each patient to achieve a modest tremor of the regional muscle and maintain De-Qi sensations, such as numbness and tingling. In both groups, electro-stimulators will be applied bilaterally to LI4 (He Gu) and P6 (Neiguan) points. The sham group will be equipped with fake devices, which look exactly like TEAS with the "in use" light flashing regularly; nevertheless, the patients will be told that they may not be able to feel the stimulation. The patients in TEAS and sham groups will be notified that they are receiving electrical stimulation.

The control group receives only PCA treatment postoperatively.

Patients will be asked a series of questions about their quality of life at the start and end of the study. Both PCA therapy and TEAS/sham will be ceased 24 hours after the surgery.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Total morphine dose (TMD) received by patient measured in mg while using PCA device in the 24 hours after surgery

Secondary outcome measures

1. The number of PCA demands, measured by times the button is pressed by the patients in the postoperative period
2. Pain measured using the score on the Visual Analogue Scale before surgery and at 4, 8, 12, 16, and 20 hours post-operation
3. The occurrence of opioid-related side effects recorded by the medical staff during the first 24 hours post-surgery

Overall trial start date

01/09/2017

Overall trial end date

01/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female patients aged 18–75 years
2. Patients undergoing elective thyroidectomy, Bethesda II-IV in thyroid BAC
3. Body mass index 18–30 kg/m²
4. ASA classification I–III
5. Patients able to provide an informed, signed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients with Bethesda V and VI in thyroid BAC
2. Patients with recurrent goiters
3. Patients with a history of allergy, hypersensitivity, or addiction to opioids
4. History of opioid intake in the past month
5. Use of monoamine oxidase and selective serotonin reuptake inhibitors
6. Patients with implanted pacemakers or cardioverter-defibrillator
7. Patients with a history of significant cardiovascular, pulmonary, renal, hepatic, or neurological disease
8. Patients with skin lesions, incision, or scar at the LI4 or P6 acupoint
9. Patients who participated in other clinical trials or received other acupuncture therapy in the previous 4 weeks

Recruitment start date

01/02/2021

Recruitment end date

01/02/2022

Locations

Countries of recruitment

Poland

Trial participating centre

Univeristy Hospital in Wroclaw
Borowska 213
Wrocław
50-556
Poland

Sponsor information

Organisation

Ministry of Science and Higher Education

Sponsor details

Hoża 20
Warszawa
00-529
Poland
+48 (0)22 52 92 718
sekretariat.bm@nauka.gov.pl

Sponsor type

Government

Website

https://www.gov.pl/web/science

Funders

Funder type

Government

Funder name

Ministerstwo Nauki i Szkolnictwa Wyższego

Alternative name(s)

Ministry of Science and Higher Education, Ministry of Science and Higher Education, Republic of Poland, MNiSW

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Poland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The protocol will be available online soon.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/04/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/12/2020: Trial's existence confirmed by the Ministry of Science and Higher Education.