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Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation

NCT04896034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2024-02-29

No results posted yet for this study

Summary

Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, alternative, soft technology, based on a cross action of LED light emission, a low intensity nanopulsed laser and a magnetic tunnel. The sessions last 10 minutes each, in total in the study two sessions will be delivered.

Conditions

  • Pelvic Pain

Interventions

DEVICE

MILTA Device

Patients in MILTA Device group will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.

DEVICE

" control 1 " fake MILTA device

Patients in group control 1 will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • Marie-Claude ANTON, MD · Clinique la Chataigneraie

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2023-04-30
Completion
2023-05-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896034 on ClinicalTrials.gov