Clinical trial NCT04896034: Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation
Official title: Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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.

Detailed description: In a woman's life, maternity is an important stage that is not without consequences, not only in daily life but also in future life. Perineal pain syndrome is a problem frequently encountered in the postpartum period and the review of the literature shows that 95 to 100% of women who have given birth by the vaginal way and who present perineal lesions, suffer from perineal pain at 24 hours of the delivery and approximately 60% of them remain painful at 7 days of the delivery. This incidence can decrease to 42% and 11% respectively in the absence of perineal lesions.

Pain in the postpartum period can not only limit a woman's mobility and affect her quality of life, but can also interfere with the care of her child and thus with the establishment of a good mother-child relationship, and thus prevent her from fulfilling her new role as a mother. Finally, acute pain that is not treated can become chronic and affect long-term physical and psychological health.

Pain management in the immediate postpartum period currently involves the use of level 1 analgesics (paracetamol, NSAIDs), the effectiveness of which is uncertain, and level 2 analgesics (weak morphine derivatives, Acupan, Tramadol), which are more effective for pain, but are sometimes badly tolerated or contraindicated in the case of breastfeeding. Recently, several publications tend to show that alternative solutions would allow a more satisfactory approach to the management of painful patients.

In this study, the investigators propose to evaluate the benefit of an innovative analgesic treatment in the immediate postpartum period using photobiomodulation (PBM) by evaluating pain using a Visual Analog Scale. PBM, discovered in the 1950s, uses the properties of light. The PBM corresponds to all the non-thermal and non-cytotoxic biological effects caused by the exposure of tissues to light sources in the visible and near-infrared range. More precisely, certain wavelengths of the light spectrum (red-infrared) lead to a cascade of biological effects within the cell: reduction of pain, regulation of inflammation and acceleration of the healing process.

The objective of this study is to analyze the possibility of replacing chemical medication by a non-invasive, painless technology in patients who have just given birth. This technology is already used for anti-inflammatory and analgesic actions in indications such as stomatology, rheumatology, post-operation and traumatology. This is part of the field of NMIs (non-medicinal interventions).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of the effectiveness of photobiomodulation (PBM) on pain in immediate postpartum patients
timeFrame: 30 minutes after first PBM session for the experimental and control 1 groups
measure: Evaluation of the effectiveness of photobiomodulation on pain in immediate postpartum patients
timeFrame: 30 minutes after first PBM session for the experimental group or 30 minutes after analgesic treatment for the group control 2
Secondary outcomes:
measure: Evaluation of the effectiveness of photobiomodulation on pain after the second PBM session
timeFrame: 30 minutes after second PBM session for the experimental and control 1 groups
measure: Characterisation of pain
timeFrame: 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2
measure: Characterisation of pain
timeFrame: 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)
measure: Evaluation of the total quantity of analgesics consumed during the hospital stay
timeFrame: through the hospital stay, an average of 2 or 3 days
measure: Evaluation of the improvement of postpartum comfort
timeFrame: 30 minutes after first PBM session for the experimental and control 1 groups and 30 minutes after analgesic treatment for the group control 2
measure: Evaluation of the improvement of postpartum comfort
timeFrame: 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)
measure: Evaluation of the involvement of caregivers during the hospital stay
timeFrame: through the hospital stay, an average of 2 or 3 days
measure: Safety evaluation
timeFrame: through study completion, an average of 10 days
Other outcomes:
Locations:
city: Beaumont
country: France
facility: Clinique la Chataigneraie
Study officials:
affiliation: Clinique la Chataigneraie
name: Marie-Claude ANTON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Morin C, Leymarie MC. La douleur périnéale en post-partum: revue de la littérature. La Revue Sage-femme (2013) 12; 263-268
citation: 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.
citation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
citation: 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.
citation: HAS. Douleur chronique: reconnaître le syndrome douloureux chronique, l'évaluer et orienter le patient. Consensus formalisé - December 2008
citation: 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.
citation: 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.
citation: Gabelle C, Cassa S, Bouvard M, Knoepffler F. Intérêts des anti-inflammatoires non stéroïdes dans les douleurs périnéales du post-partum. J Gyneco. Obst. Biol. Reprod (2004) 33(1): 67 (10)
citation: Wehrle M. Prise en charge de la douleur post-épisiotomie en suites de couches: Analyse des pratiques professionnelles à la Maternité Régionale Universitaire de Nancy. Mémoire Université de Lorraine (2015) hal-02110831.
citation: 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.
citation: Golka M. Haute fréquence et douleur périnéale du post-partum. Mémoire Université d'Aix Marseille (2017) dumas-01646228
citation: Boureau F, Luu M. Méthodes d'évaluation de la douleur. Douleur et Analgésie (1988) 6; 1(2): 65-78.
citation: 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.
citation: Moreira Rocha Jr A. Et al. Effects of Low-Level Laser Therapy on the progress of wound healing in humans: the contribution of in vitro and in vivo experimental studies. J. Vas. Bras 2007; 6(3): 258-266
citation: Luo L, Sun Z, Zhang L, Li X, Dong Y, Liu TC. Effects of low-level laser therapy on ROS homeostasis and expression of IGF-1 and TGF-beta1 in skeletal muscle during the repair process. Lasers Med Sci. 2013 May;28(3):725-34. doi: 10.1007/s10103-012-1133-0. Epub 2012 Jun 20.
citation: Cidral-Filho FJ, Mazzardo-Martins L, Martins DF, Santos AR. Light-emitting diode therapy induces analgesia in a mouse model of postoperative pain through activation of peripheral opioid receptors and the L-arginine/nitric oxide pathway. Lasers Med Sci. 2014 Mar;29(2):695-702. doi: 10.1007/s10103-013-1385-3. Epub 2013 Jul 6.
citation: Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD. The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004 Aug;22(4):323-9. doi: 10.1089/pho.2004.22.323.
citation: Ahangar FA et Al. Efficace of nano-pulsed magneto infrared Laser Therapy with a fixed dose combination tablet of oral Ibuprofen and paracetamol on the reduction of endodontie pain: a clinical study. Contemporary Med. Res. (2017); 4(8): 1782-1787
citation: Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.
citation: Ezzati K, Fekrazad R, Raoufi Z. The Effects of Photobiomodulation Therapy on Post-Surgical Pain. J Lasers Med Sci. 2019 Spring;10(2):79-85. doi: 10.15171/jlms.2019.13. Epub 2019 Feb 25.
citation: FDA, Multiple Endpoints in Clinical Trials Guidance for Industry, January 2017