Transcutaneous Electric Nerve StimulationNCT03762486

The Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision

A study testing TENS and TAES in people with Transcutaneous Electric Nerve Stimulation, run by Yuksek Ihtisas University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Transcutaneous Electric Nerve Stimulation
What is being tested?: TENS and TAES
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: 12 May 2015to 30 Nov 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients who had an American Society of Anesthesiologists (ASA) score of I-II
Patients were aged over 18 years
Patients who could read and write Turkish
Patients who were scheduled to undergo elective abdominal surgery with a midline incision for a diagnosis of stomach or colorectal cancer
Patients without any impairment of vision, hearing or speech

Who cannot join

Patients who had a pacemaker
Patients whose skin integrity around the incision was degraded
Patients had a cognitive disorder, had a history of chronic pain, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results
Patients with an opioid addiction
Patients those who had previously undergone electrical stimulation treatment
Morbidly obese subjects
Patients using psychoactive drugs

About this study

Official title: The Effects of Two Different Electrical Stimulation Methods on the Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision: Randomized Controlled Clinical Trial

The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and analgesic drug consumption in patients who had undergone abdominal surgery with a midline incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and analgesic consumption on patients undergoing abdominal surgery with severe pain experience and high levels of neuroendocrine stress response is uncertain.

Read the detailed description

This research was conducted as a randomized controlled trial. 158 patients who had undergone abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for eligibility. This research sample consisted of 48 patients who underwent abdominal surgery with a midline incision. The patients were randomized into three groups, the first intervention group, which used TENS (around the incision), the second intervention group, which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and 45th hours after the operation. Pain scores and analgesic consumption were assessed in the first 48 hours after surgical intervention.

Conditions: Transcutaneous Electric Nerve Stimulation
Being tested: TENS, TAES
Keywords: Postoperative pain, Alternative therapy, Acupuncture, TENS, Surgical nursing, Randomised controlled trial
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENSOther
Also called First Intervention Group
4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
TAESOther
Also called Second Intervention Group
4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min

Study groups in NCT03762486
Study group	Role	What they receive
TENS to around the incision	Active comparator	The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision. Receives: Other: TENS
TAES to the acupuncture points	Active comparator	The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points. Receives: Other: TAES
No stimulation	No intervention	No stimulation was performed to the patients in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative pain intensity
First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.
Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.
Control Group: No intervention was performed to the patients in the control group.
The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.
Measured: The pain levels were evaluated and compared within postoperative first 48 hours.

Secondary outcomes (5)

Nausea severity
VAS with a range of 1-10 points was used while evaluating the nausea severity of all patients .The increase of the scale score shows that the nausea severity increases.
Measured: The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Antiemetic drug consumption
The antiemetic drug amount administered to the patients was recorded in mg.
Measured: Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
Pulmonary function tests
The pulmonary functions of the patients were evaluated with a portable spirometer. Peak expiratory flow (PEF) and forced vital capacity (FVC) values were recorded. The measurement of respiratory functions was performed with the patient wrapping the disposable mouthpiece well with the lips during the measurement. The patient was asked to breathe deeply and exhale suddenly and quickly. This process was repeated three times and the best performance was taken as the base value.
Measured: Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.
Vomiting
Vomiting: The number of times the patients vomited was recorded
Measured: Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Analgesic drug consumption
All patients were administered intravenous tramadol hydrochloride infusion with the Patient Controlled Analgesia for the first 48 hours. Dexketoprofen trometamol vial intravenous and/or 50 mg. Pethidine hydrochloride intramuscular was used as the rescue analgesic.
Measured: Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201530 Nov 2016

First posted3 Dec 2018
Study start12 May 2015
Primary completion30 Nov 2016
Study completion30 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Transcutaneous Electric Nerve StimulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Model description: TENS was applied to around the insicion: Transcutaneous electrical nerve stimulation was applied to around the incision. TAES was applied to acupuncture points: Transcutaneous electrical stimulation was applied to acupuncture points. No intervention: No stimulation was performed to the patients. A standard analgesia protocol for post-operative pain control was used in all patients included in the study. A standard antiemetic protocol was used for all patients after surgery.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03762486
Sponsor's protocol ID: YuksekIU
Status last verified: Mar 2018
First submitted: 5 Jan 2018
Last updated: 3 Dec 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3.
PubMed 14716650
Wu MS, Chen KH, Chen IF, Huang SK, Tzeng PC, Yeh ML, Lee FP, Lin JG, Chen C. The Efficacy of Acupuncture in Post-Operative Pain Management: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 9;11(3):e0150367. doi: 10.1371/journal.pone.0150367. eCollection 2016.
PubMed 26959661
Dias M, Carneiro NM, Guerra LA, Velarde GC, de Souza PA, da Silva LL, de Abreu e Souza RR, Nolasco R, Olej B. Effects of electroacupuncture on local anaesthesia for inguinal hernia repair: a randomised placebo-controlled trial. Acupunct Med. 2010 Jun;28(2):65-70. doi: 10.1136/aim.2009.000570.
PubMed 20615859
Bjersa K, Andersson T. High frequency TENS as a complement for pain relief in postoperative transition from epidural to general analgesia after pancreatic resection. Complement Ther Clin Pract. 2014 Feb;20(1):5-10. doi: 10.1016/j.ctcp.2013.11.004. Epub 2013 Nov 20.
PubMed 24439637
Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
PubMed 12600800
Chen L, Tang J, White PF, Sloninsky A, Wender RH, Naruse R, Kariger R. The effect of location of transcutaneous electrical nerve stimulation on postoperative opioid analgesic requirement: acupoint versus nonacupoint stimulation. Anesth Analg. 1998 Nov;87(5):1129-34.
PubMed 9806695
Chen Y, Yang Y, Yao Y, Dai D, Qian B, Liu P. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial. Int J Clin Exp Med. 2015 Aug 15;8(8):13622-7. eCollection 2015.
PubMed 26550304
da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
PubMed 25665520
DeSantana JM, Santana-Filho VJ, Guerra DR, Sluka KA, Gurgel RQ, da Silva WM Jr. Hypoalgesic effect of the transcutaneous electrical nerve stimulation following inguinal herniorrhaphy: a randomized, controlled trial. J Pain. 2008 Jul;9(7):623-9. doi: 10.1016/j.jpain.2008.01.337. Epub 2008 Apr 3.
PubMed 18387854
Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.
PubMed 25935320
Lan F, Ma YH, Xue JX, Wang TL, Ma DQ. Transcutaneous electrical nerve stimulation on acupoints reduces fentanyl requirement for postoperative pain relief after total hip arthroplasty in elderly patients. Minerva Anestesiol. 2012 Aug;78(8):887-95. Epub 2012 Apr 24.
PubMed 22531569
Feng X, Ye T, Wang Z, Chen X, Cong W, Chen Y, Chen P, Chen C, Shi B, Xie W. Transcutaneous acupoint electrical stimulation pain management after surgical abortion: A cohort study. Int J Surg. 2016 Jun;30:104-8. doi: 10.1016/j.ijsu.2016.04.042. Epub 2016 Apr 29.
PubMed 27142864
Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.
PubMed 24576720
Hong SJ, Lee E. Effect of evidence-based postoperative pain guidelines via web for patients undergoing abdominal surgery in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2014 Jun;8(2):135-42. doi: 10.1016/j.anr.2014.05.005. Epub 2014 May 21.
PubMed 25030646
Kara B, Baskurt F, Acar S, Karadibak D, Ciftci L, Erbayraktar S, Gokmen AN. The effect of TENS on pain, function, depression, and analgesic consumption in the early postoperative period with spinal surgery patients. Turk Neurosurg. 2011;21(4):618-24.
PubMed 22194125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Two Different Electrical Stimulation Methods on the Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision: Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03762486
Acronym / sponsor ID: YuksekIU
Conditions: Transcutaneous Electric Nerve Stimulation
Keywords: Postoperative pain, Alternative therapy, Acupuncture, TENS, Surgical nursing, Randomised controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Yuksek Ihtisas UniversityUniversity, hospital or other
Study start: 12 May 2015 (actual)
Primary completion: 30 Nov 2016 (actual)
Study completion: 30 Nov 2016 (actual)
First posted: 3 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3
Model description: TENS was applied to around the insicion: Transcutaneous electrical nerve stimulation was applied to around the incision. TAES was applied to acupuncture points: Transcutaneous electrical stimulation was applied to acupuncture points. No intervention: No stimulation was performed to the patients. A standard analgesia protocol for post-operative pain control was used in all patients included in the study. A standard antiemetic protocol was used for all patients after surgery.

Arm	Type	Receives
TENS to around the incision	Active comparator	Other: TENSThe Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.
TAES to the acupuncture points	Active comparator	Other: TAESThe Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.
No stimulation	No intervention	–No stimulation was performed to the patients in the control group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients who had an American Society of Anesthesiologists (ASA) score of I-II
Patients were aged over 18 years
Patients who could read and write Turkish
Patients who were scheduled to undergo elective abdominal surgery with a midline incision for a diagnosis of stomach or colorectal cancer
Patients without any impairment of vision, hearing or speech

Key exclusion criteria (7 listed)

Patients who had a pacemaker
Patients whose skin integrity around the incision was degraded
Patients had a cognitive disorder, had a history of chronic pain, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results
Patients with an opioid addiction
Patients those who had previously undergone electrical stimulation treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENSAlso: First Intervention Group4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min	Other	TENS to around the incision
TAESAlso: Second Intervention Group4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min	Other	TAES to the acupuncture points

Primary outcome

Postoperative pain intensity
Time frame: The pain levels were evaluated and compared within postoperative first 48 hours.
First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery. Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery. Control Group: No intervention was performed to the patients in the control group. The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.

5 secondary outcomes

Nausea severity
Time frame: The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Antiemetic drug consumption
Time frame: Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
Pulmonary function tests
Time frame: Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.
Vomiting
Time frame: Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
Analgesic drug consumption
Time frame: Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
Background: PubMed 14716650Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3.
Background: PubMed 26959661Wu MS, Chen KH, Chen IF, Huang SK, Tzeng PC, Yeh ML, Lee FP, Lin JG, Chen C. The Efficacy of Acupuncture in Post-Operative Pain Management: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 9;11(3):e0150367. doi: 10.1371/journal.pone.0150367. eCollection 2016.
Results publication: PubMed 20615859Dias M, Carneiro NM, Guerra LA, Velarde GC, de Souza PA, da Silva LL, de Abreu e Souza RR, Nolasco R, Olej B. Effects of electroacupuncture on local anaesthesia for inguinal hernia repair: a randomised placebo-controlled trial. Acupunct Med. 2010 Jun;28(2):65-70. doi: 10.1136/aim.2009.000570.
Results publication: PubMed 24439637Bjersa K, Andersson T. High frequency TENS as a complement for pain relief in postoperative transition from epidural to general analgesia after pancreatic resection. Complement Ther Clin Pract. 2014 Feb;20(1):5-10. doi: 10.1016/j.ctcp.2013.11.004. Epub 2013 Nov 20.
Results publication: PubMed 12600800Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
Results publication: PubMed 9806695Chen L, Tang J, White PF, Sloninsky A, Wender RH, Naruse R, Kariger R. The effect of location of transcutaneous electrical nerve stimulation on postoperative opioid analgesic requirement: acupoint versus nonacupoint stimulation. Anesth Analg. 1998 Nov;87(5):1129-34.
Results publication: PubMed 26550304Chen Y, Yang Y, Yao Y, Dai D, Qian B, Liu P. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial. Int J Clin Exp Med. 2015 Aug 15;8(8):13622-7. eCollection 2015.
Results publication: PubMed 25665520da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
Results publication: PubMed 18387854DeSantana JM, Santana-Filho VJ, Guerra DR, Sluka KA, Gurgel RQ, da Silva WM Jr. Hypoalgesic effect of the transcutaneous electrical nerve stimulation following inguinal herniorrhaphy: a randomized, controlled trial. J Pain. 2008 Jul;9(7):623-9. doi: 10.1016/j.jpain.2008.01.337. Epub 2008 Apr 3.
Results publication: PubMed 25935320Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.
Results publication: PubMed 22531569Lan F, Ma YH, Xue JX, Wang TL, Ma DQ. Transcutaneous electrical nerve stimulation on acupoints reduces fentanyl requirement for postoperative pain relief after total hip arthroplasty in elderly patients. Minerva Anestesiol. 2012 Aug;78(8):887-95. Epub 2012 Apr 24.
Results publication: PubMed 27142864Feng X, Ye T, Wang Z, Chen X, Cong W, Chen Y, Chen P, Chen C, Shi B, Xie W. Transcutaneous acupoint electrical stimulation pain management after surgical abortion: A cohort study. Int J Surg. 2016 Jun;30:104-8. doi: 10.1016/j.ijsu.2016.04.042. Epub 2016 Apr 29.
for access to resourcesLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emine Iyigun, Professor study director

Turkish Nurses Society

Questions about this trial

What is this clinical trial studying?

A study testing TENS and TAES in people with Transcutaneous Electric Nerve Stimulation, run by Yuksek Ihtisas University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain intensity (time frame: The pain levels were evaluated and compared within postoperative first 48 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762486, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.