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

NCT04896034 | Completed

• 2 other identifiers: PBM study2020-A00447-32
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients

  Evaluated the superiority of the experimental group (MILTA device) to control 1 (fake device) using a Visual Analog Scale (VAS) collected before and after pain management (1st session of PBM)

  30 minutes after first PBM session for the experimental and control 1 groups

• Evaluation of the effectiveness of photobiomodulation on pain in immediate postpartum patients

  Evaluated the non-inferiority with of the experimental group (MILTA device) to control 2 (standard of care) using a Visual Analog Scale (VAS) collected before and after pain management

  30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2

Secondary Outcomes (8)

• Evaluation of the effectiveness of photobiomodulation on pain after the second PBM session

  30 minutes after second PBM session for the experimental and control 1 groups

• Characterisation of pain

  30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2

• Characterisation of pain

  30 minutes after second PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2 (Day 1)

• Evaluation of the total quantity of analgesics consumed during the hospital stay

  through the hospital stay, an average of 2 or 3 days

• Evaluation of the improvement of postpartum comfort

  30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2

Study Arms (3)

" control 1 " fake MILTA device

PLACEBO COMPARATOR

Fake device (control 1) which emits 10% red light (and no infrared) so that the difference between the two machines cannot be seen with the naked eye. The magnets present in the real device are absent in the fake machine and replaced by inert materials of the same mass.

Device: " control 1 " fake MILTA device

MILTA Device

EXPERIMENTAL

The MILTA device used for the study is composed of a panel which gathers 18 emitters composed of red, green and blue LEDs, 3 nanopulsed infrared laser diodes (cold laser), 3 infrared diodes and a permanent magnet

Device: MILTA Device

" control 2 " standard pain management with medication

NO INTERVENTION

In first intention: PARACETAMOL: max 1 g x 4 / 24 h Second intention: IBUPROFEN: max 100 mg x 2 for 48 h Third intention: ACUPAN 20 mg in sugar 3 times per 24 h Last intention: ACTISKENAN 10 mg x 4 / 24 h

Interventions

MILTA Device 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.

MILTA Device

" control 1 " fake MILTA device 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.

" control 1 " fake MILTA device

Eligibility Criteria

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

You may qualify if:

• Woman aged 18 years or older
• Primi or multiparous patient
• Natural childbirth, regardless of the method of extraction (spontaneous, vacuum, forceps), and damage to the perineum (simple tear, episiotomy, obstetric anal sphincter injury)
• Patients affiliated to a health insurance plan
• Agreeing to participate in the study and having signed an informed consent

You may not qualify if:

• Immediate complications related to the childbirth and requiring management in the continuing care unit (delivery haemorrhage, eclampsia, etc.)
• Severe neonatal complications requiring reanimation.
• Patient with a cardiac pacemaker
• Presence of a disease and/or taking photo-sensitising treatment
• Patient under legal protection

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique la Chataigneraie

Beaumont, 63110, France

Location

Related Publications (22)

• Persico G, Vergani P, Cestaro C, Grandolfo M, Nespoli A. Assessment of postpartum perineal pain after vaginal delivery: prevalence, severity and determinants. A prospective observational study. Minerva Ginecol. 2013 Dec;65(6):669-78.

  PMID: 24346253 BACKGROUND

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  BACKGROUND

• Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.

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• Turmo M, Echevarria M, Rubio P, Almeida C. Development of chronic pain after episiotomy. Rev Esp Anestesiol Reanim. 2015 Oct;62(8):436-42. doi: 10.1016/j.redar.2014.10.008. Epub 2014 Dec 30. English, Spanish.

  PMID: 25555717 BACKGROUND

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• Skovlund E, Fyllingen G, Landre H, Nesheim BI. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol. 1991;40(4):343-7. doi: 10.1007/BF00265841.

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• Behotas S, Chauvin A, Castiel J, Martin A, Boureau F, Barrat J, Lienhart A. [Analgesic effect of ibuprofen in pain after episiotomy]. Ann Fr Anesth Reanim. 1992;11(1):22-6. doi: 10.1016/s0750-7658(05)80316-8. French.

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• Battut A, Nizard J. [Impact of pelvic floor muscle training on prevention of perineal pain and dyspareunia in postpartum]. Prog Urol. 2016 Mar;26(4):237-44. doi: 10.1016/j.purol.2015.09.006. Epub 2015 Oct 9. French.

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• Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.

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  BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie-Claude ANTON, MD

  Clinique la Chataigneraie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The experimental group (real device) and the control 1 group ( fake device) will be in double-blind, neither the investigator nor the patient will know the allocated group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, adaptive, prospective, three-arm randomized, controlled, double-blind study for 2 arms. 3 groups will be constituted, according to a 1:3:3 ratio: * 1 group " control 1 " with 2 sessions of PBM ( fake device). * 1 experimental group with 2 sessions of PBM (real device) * 1 group " control 2 " with standard pain management (i.e. medication).

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 21, 2021
• Study Start: May 6, 2021
• Primary Completion: April 30, 2023
• Study Completion: May 12, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)