Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair (TENS1)

February 17, 2021 updated by: Audrius Paršeliūnas, Lithuanian University of Health Sciences

Impact of Transcutaneous Electric Nerve Stimulation (TENS) on Postoperative Pain and Quality of Life (QoL) After Inguinal Hernia Repair

Lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia repair techniques. It is frequently associated with acute postoperative and chronic pain. Due to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed. However opioids have many side effects. Interventional treatment, such as transversus abdominis plain (TAP) block requires an additional intervention and has relatively short effect, also could not be applied in outpatient conditions. The hypoalgesic effect of transcutaneous electric nerve stimulation (TENS) is well known for many years, but effectiveness during postoperative period is still controversial and maybe therefore didn't come to daily practice. However it could be a promising part of multi-modal pain treatment for hernia patients. This study analyse the hypoalgesic effect of TENS and its impact on hernia specific quality of life (QoL) after Lichtenstein hernia repair.

Aim#1 To determine whether use of TENS is effective for acute postoperative pain relief.

Aim#2 To determine whether use of TENS have impact on hernia specific QoL in early and late postoperative period.

Aim#3 To identify factors associated with effectiveness/ineffectiveness of TENS procedures.

Aim#4 To determine whether a psychological condition (depression, anxiety and pain catastrophisation) is somehow associated with TENS effectiveness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania, LT44307
        • Lithuanian University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Elective Lichtenstein repair for primary hernia
  • Male gender
  • No TENS procedures in the past
  • American Society of Anesthesiologists physical status I or II
  • No cognitive, speaking, hearing or visual disturbances
  • No movement disorders

Exclusion Criteria:

  • Non Lithuanian speaker
  • Known allergy to a patch glue
  • Chronic use of non-steroidal anti inflammatory drugs or opioids
  • Neuropathic diseases
  • General contraindication for TENS procedures (such as skin disorders in site of electrodes application or pacemaker)
  • Not able to complete the questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active TENS group
Conventional transcutaneous electric nerve stimulation
Device: Transcutaneous electric nerve stimulation
Conventional transcutaneous electric nerve stimulation
Other Names:
  • TENS
Placebo Comparator: Placebo TENS group
0 amperes transcutaneous electric nerve stimulation
Device: Transcutaneous electric nerve stimulation
Conventional transcutaneous electric nerve stimulation
Other Names:
  • TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain level as assessed by the VAS.
Time Frame: 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Pain is assessed using a 100 mm handheld slide rule-type visual analogue scale (VAS) with values from 0 to 100 (0 = no pain, 100 = extreme pain) during lying, waking and getting out of bed. Total scores are averaged.
10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pressure pain threshold.
Time Frame: 1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Pressure pain threshold assessed using digital pressure algometer examination in inguinal region (hernia and contralateral side). Pressure in newtons (N) that evokes minimal sensation of pain is assessed.
1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Change in pressure pain tolerance.
Time Frame: 1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Pressure pain tolerance assessed using digital pressure algometer examination in inguinal region (hernia and contralateral side). Pressure in newtons (N) that evokes maximal tolerable sensation of pain is assessed.
1 hour before surgery (baseline), 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Change in hernia specific quality of life.
Time Frame: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Hernia specific quality of life is assessed using self reported questionnaire Carolina's comfort scale (CCS) application, providing a 0 to 115 score.
1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Change in overall quality of life.
Time Frame: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Overall quality of life is assessed using self reported short form (36) health survey questionnaire (SF-36) application.The SF-36 consists of 36 items, that aggregate into 8 parts: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored on a value of 0 (poor health) to 100 (best health).
1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Consumption of analgesic drugs.
Time Frame: 2 days postoperative
The total amount of drugs, used for pain relief in hospital.
2 days postoperative
Depression status influence to TENS effectiveness.
Time Frame: 2 days postoperative
Depression status is assessed using preoperative completed patient health questionnaire- 9 (PHQ-9), providing a 0 to 27 severity score.
2 days postoperative
Anxiety status influence to TENS effectiveness.
Time Frame: 2 days postoperative
Anxiety status is assessed using preoperative completed generalized anxiety disorder scale -7 (GAD-7), providing a 0 to 21 severity score.
2 days postoperative
Pain catastrophizing influence to TENS effectiveness.
Time Frame: 2 days postoperative
Pain catastrophizing is assessed using preoperative completed pain catastrophizing scale (PCS) questionnaire, providing a 0 to 52 score.
2 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Investigators

  • Principal Investigator: Audrius Paršeliūnas, MD, Lithuanian University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

February 8, 2020

Study Completion (Actual)

July 8, 2020

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENS1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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