Transcutaneous Electrical Nerve Stimulation for Labor Pain Control in Combination With Cardiotocography

NCT04946838 | Completed DMC

• 1 other identifier: 20210423
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. It is aimed to investigate TENS1 alternating between 4 to 100 Hz compared to sham-TENS. The present study aims to evaluate TENS in combination with cardiotocography (CTG). The combination of TENS with CTG in a feedback-loop has not been reported in any studies before.

Conditions

Labor Pain

Keywords

TENS; Labor pain; Childbirth; RCT; Pilot study

Outcome Measures

Primary Outcomes (2)

• Visual Analog scale (VAS)

  10-cm pain intensity scale with 0 cm is no pain and 10 cm is unbearable pain. Decreased cm after baseline measurement indicates pain relief.

  Baseline, 10 minutes post stimulation, 30 minutes post stimulation

• Pain pressure threshold (PPT)

  Pain sensitivity measurement also defined as the minimum pressure needed to evoke a pain response measured in kPa. Increased kPa after baseline measurement indicates pain relief.

  Baseline, 10 minutes post stimulation, 30 minutes post stimulation

Secondary Outcomes (4)

• Satisfaction of TENS

  Right after last measurements of VAS & PPT

• Experienced pain reduction

  Right after last measurements of VAS & PPT

• Interest in the use of TENS again

  Right after last measurements of VAS & PPT

• Recommend TENS to others

  Right after last measurements of VAS & PPT

Study Arms (2)

TENS

EXPERIMENTAL

TENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.

Device: DS5 electrical stimulator

Sham-TENS

SHAM COMPARATOR

Sham with 100 Hz in frequency, 200 µs in pulse duration, and intensity below 5 mA.

Device: DS5 electrical stimulator

Interventions

DS5 electrical stimulator DEVICE

TENS

Sham-TENS; TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy
• Vertex presentation
• Speak, read and understand Danish

You may not qualify if:

• Gestational age \< 37+0 weeks
• Gestational age \> to 41+6 weeks
• High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension (above 140/90), and hypotension (below 90/60), Intrauterine growth restriction (IUGR), polyhydramnious, and oligohydramnious).
• Pre-gestational body mass index (BMI) above 40 kg/m2
• Use of fetal scalp-electrode during the experiment
• Use of pacemakers and other electronic implants
• Severe arrhythmia
• Present musculoskeletal illnesses (including myopathy and arthritis).
• Chronic pain within last 6 months (Pelvic girdle pain (PGP) to a mild degree (VAS 0-6 cm) is accepted in the experiment. Severe degree (VAS 6-10 cm) (e.g. bedridden or difficulty walking) especially within 24 hours before birth is excluded).
• Present/previous neurologic illnesses (including epilepsy, migraine, and sclerosis).
• Present medicated mental disorders (including dementia, personality disorders, bipolar, ADHD, and anxiety).
• Dermatological disorders (including skin allergy, tattoos or scars on the locations of electrodes)
• Use of other long-acting pain relief before the experiment (including Epidural, Morphine less than 16 hours before experiment), Acupuncture, Paracetamol (less than 8 hours before experiment), Cocktail (less than 8 hours before experiment), nitrous oxide (less than one hour before experiment), sterile water injection (less than two hours before experiment).
• Use of TENS 48 hours before the trial
• Drug addiction defined as the use of cannabis, opioids or other drugs.

Sponsors & Collaborators

• Aalborg University: lead
• Centaflow: collaborator

Study Sites (1)

Region Hospital Gødstrup

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Parisa Gazerani, PhD

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 2 groups (TENS and sham)

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: July 9, 2021
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will also be published after the manuscript publication. Expected to be published after September 2021.

Locations

DK (1)