NCT05345600: MILTADoIP

MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery

Active, enrolled NA Last updated 19 November 2025

What this trial tests

NA trial testing MILTA probe in Perineal Scars in 110 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 January 2022

Primary endpoint
23 March 2023

23 November 2025

Quick facts

Lead sponsor	Centre Hospitalier Universitaire, Amiens
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	31 January 2022
Primary completion	23 March 2023
Estimated completion	23 November 2025
Sites	1 location across France

Drugs / interventions tested

• MILTA probe
• placebo probe

Conditions studied

• Perineal Scars — all drugs for Perineal Scars →
• Delivery Complication — all drugs for Delivery Complication →
• Episiotomy — all drugs for Episiotomy →
• Pain — all drugs for Pain →

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, female only, with Perineal Scars or Delivery Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.

The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.

This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The utilization of nanotechnology in the female reproductive system and related disorders.
   Luo X, Jia K, Xing J, Yi J. · · 2024 · cited 12× · PMID 38333849 · DOI 10.1016/j.heliyon.2024.e25477