Inguinal HerniaTENS1NCT03739060
Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair
A study testing Transcutaneous electric nerve stimulation in people with Inguinal Hernia and Postoperative Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain, Quality of Life
- What is being tested?
- Transcutaneous electric nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Aug 2018to 8 Jul 2020
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Inguinal Hernia, Postoperative Pain, Quality of Life, Transcutaneous Electric Nerve Stimulation
- Being tested
- Transcutaneous electric nerve stimulation
- Keywords
- Inguinal hernia, Transcutaneous electric nerve stimulation, Postoperative pain, Quality of life, Pain threshold, Algometry
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electric nerve stimulationDevice
Also called TENS
Conventional transcutaneous electric nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active TENS group | Active comparator | Conventional transcutaneous electric nerve stimulation Receives: Device: Transcutaneous electric nerve stimulation |
| Placebo TENS group | Placebo comparator | 0 amperes transcutaneous electric nerve stimulation Receives: Device: Transcutaneous electric nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level as assessed by the VAS.
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.
Measured: 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery.
Secondary outcomes (8)
Change in pressure pain threshold.
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.
Measured: 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.
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.
Measured: 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.
Hernia specific quality of life is assessed using self reported questionnaire Carolina's comfort scale (CCS) application, providing a 0 to 115 score.
Measured: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Change in overall quality of life.
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).
Measured: 1 hour before surgery (baseline), 2 days, 1 week, 4 weeks and 6 month after surgery.
Consumption of analgesic drugs.
The total amount of drugs, used for pain relief in hospital.
Measured: 2 days postoperative
Depression status influence to TENS effectiveness.
Depression status is assessed using preoperative completed patient health questionnaire- 9 (PHQ-9), providing a 0 to 27 severity score.
Measured: 2 days postoperative
Anxiety status influence to TENS effectiveness.
Anxiety status is assessed using preoperative completed generalized anxiety disorder scale -7 (GAD-7), providing a 0 to 21 severity score.
Measured: 2 days postoperative
Pain catastrophizing influence to TENS effectiveness.
Pain catastrophizing is assessed using preoperative completed pain catastrophizing scale (PCS) questionnaire, providing a 0 to 52 score.
Measured: 2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Aug 2018
- Primary completion8 Feb 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrius Paršeliūnas, Lithuanian University of Health Sciences
- Investigators
- Audrius Paršeliūnas, MD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739060
- Sponsor's protocol ID
- TENS1
- Acronym
- TENS1
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2018
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parseliunas A, Paskauskas S, Kubiliute E, Vaitekunas J, Venskutonis D. Transcutaneous Electric Nerve Stimulation Reduces Acute Postoperative Pain and Analgesic Use After Open Inguinal Hernia Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2021 May;22(5):533-544. doi: 10.1016/j.jpain.2020.11.006. Epub 2020 Dec 10.
PubMed 33309784
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcutaneous Electric Nerve Stimulation (TENS) on Postoperative Pain and Quality of Life (QoL) After Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03739060
- Acronym / sponsor ID
- TENS1 / TENS1
- Conditions
- Inguinal Hernia, Postoperative Pain, Quality of Life, Transcutaneous Electric Nerve Stimulation
- Keywords
- Inguinal hernia, Transcutaneous electric nerve stimulation, Postoperative pain, Quality of life, Pain threshold, Algometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 13 Nov 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS group | Active comparator | Device: Transcutaneous electric nerve stimulationConventional transcutaneous electric nerve stimulation |
| Placebo TENS group | Placebo comparator | Device: Transcutaneous electric nerve stimulation0 amperes transcutaneous electric nerve stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Transcutaneous electric nerve stimulationAlso: TENSConventional transcutaneous electric nerve stimulation | Device | Active TENS group, Placebo TENS group |
Primary outcome
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.
8 secondary outcomes
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.
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.
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.
Change in overall quality of life.
Time frame: 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
Depression status influence to TENS effectiveness.
Time frame: 2 days postoperative
Anxiety status influence to TENS effectiveness.
Time frame: 2 days postoperative
Pain catastrophizing influence to TENS effectiveness.
Time frame: 2 days postoperative
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 18 Feb 2021.
- Derived from this study: PubMed 33309784Parseliunas A, Paskauskas S, Kubiliute E, Vaitekunas J, Venskutonis D. Transcutaneous Electric Nerve Stimulation Reduces Acute Postoperative Pain and Analgesic Use After Open Inguinal Hernia Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2021 May;22(5):533-544. doi: 10.1016/j.jpain.2020.11.006. Epub 2020 Dec 10.
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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.
Audrius Paršeliūnas, MD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electric nerve stimulation in people with Inguinal Hernia and Postoperative Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 6 inclusion and 6 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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.). 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 NCT03739060, which also lists 1 linked publication.
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 18 Feb 2021.