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

Not Applicable

Active, not recruiting

• Conditions: Delivery Complication; Episiotomy; Pain; Perineal Scars; Treatment
• Interventions: Other: placebo probe; Other: MILTA probe

• Registration Number: NCT05345600
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-26
• Primary Completion: 2023-03-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Study Completion: 2025-07-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• vaginal delivery less than 24h before inclusion
• perineal scar with pain assessed as > 3/10 with a numerical scale
• 18-years-old or older
• registration to the French medical system
• speaking and writing French
• written informed consent signed

Exclusion Criteria

• woman under 18-years-old
• woman under law liberty restriction
• women unable to understand the written informed consent
• no written informed consent signed
• previous perineal surgery
• delivery with a caesarian section
• vaginal delivery with no perineal scar
• vaginal delivery with infected perineal scar
• women with restrictions for the use of level 1 analgesic
• women requiring level 2 or 3 analgesics for other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo probe	-
MILTA	MILTA probe	The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain

Primary Outcome Measures

Name	Time	Method
pain level	day 3	Pain Level will be determined with EQ-5D instrument. The EQ-5D index scores were derived from the current UK tariff, which has a maximum value of 1 and a minimum value of -0.59.; EQ-5D comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding.

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France