Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling

Summary

Osteopathy is an emerging field of clinical research. Here we present a protocol to assess the efficacy of an osteopathic intervention coupled with lactation consultation, in infants with biomechanical issues impeding breastfeeding.

Abstract

Breastfeeding can be challenging for mother-infant dyads experiencing biomechanical suckling difficulties. Although lactation consultants (LCs) all over the world have increased their skills in this field and can provide support to help position the infant at the breast, the impact of their intervention might be limited in the presence of stiff structures in the infants. Here we present a protocol for a randomized controlled trial to assess the efficacy of osteopathic treatment, coupled with lactation consultation, for infants' biomechanical suckling difficulties. It proposes a set-up and a sequence of actions to ensure an optimal context for treatment, as well as a blinding of parents and LCs to the intervention. Data such as the infant's latch ability measured with the LATCH Assessment Tool, the mother's nipple pain with a visual analog scale (VAS), and the mother's perceptions are collected by LCs four times over a 10-day period. Osteopathic lesions are documented by the osteopath, using a standardized assessment grid. Structures of interest are coherent with the anatomical zones involved in latching onto the breast. This protocol also proposes a strategy to document systematically an osteopathic profile of infants with biomechanical suckling difficulties in their first weeks of life. The implementation of this protocol confirms its feasibility for osteopathic assessment and treatment and paves the way for future trials to further explore the efficacy of osteopathic techniques for infants with biomechanical suckling difficulties.

Introduction

Over the last thirty years, international recommendations from the World Health Organization¹, followed by national recommendations in many countries^2,3,4, have advocated for breastfeeding. Its health benefits are now well-known^5,6 and breastfeeding exclusively for the first six months of the infant's life and maintaining it for two years or longer is described as the norm¹.

As highlighted by Homdrum and Miller⁷, more than half of the mothers who stop breastfeeding within the first month reported biomechanical difficulties. Suckling biomechanical issues typically include suboptimal head extension and rotation, restricted mouth opening or jaw stiffness, biting the nipple, restricted tongue mobility, and inefficient mouth vacuum to stimulate the release of milk from the mother's breast⁸. Any neurological impairment also affects the optimal function of the normal primitive reflexes, crucial to an optimal latch.

The emergence of LCs worldwide has provided a great source of breastfeeding support for mother-infant dyads and has contributed to increasing the scientific knowledge in this specific field. For example, LCs have studied extensively the biomechanics of suckling from birth to weaning. In parallel, they have created tools to assess the function of breastfeeding and to efficiently detect dyads with special needs^9,10.

Osteopathy is a manual practice meant to restore normal functions of the human body, based on the body's capacity for self-regulation¹¹ and structure-function relationship¹. During an osteopathic consultation, various palpation techniques are used, based on thorough knowledge of human anatomy and physiology¹². Some scholars have linked physical restrictions with suckling dysfunction^{13,14,15,16,17}. Restrictions of skull sutures or motility of skull bones have also been described to impact an infant's ability to latch^{13,14,15,16,17,18}. However, research on the efficacy of osteopathy techniques on biomechanical suckling difficulties is scarce^19,20.

Aside from a few case reports describing an osteopathic intervention to improve an infant's ability to latch^21,22, only one pilot study²³ documented the impact of such interventions. Six infants between three to six weeks of age were recruited and assessed by an LC. Mothers were given breastfeeding advice and then met the osteopath. Four treatments (once a week for four weeks) were performed. Treated infants were compared with six control infants whose mothers received only LC support. The authors found improvement in the milk fat content, which has been shown to be a marker for effective feeding²⁴. Due to its small sample, these pilot study results are not generalizable but established the feasibility of a randomized controlled trial coupling the expertise of LCs and osteopaths.

These studies have paved the way for a single-blind randomized controlled trial to assess the efficacy of an osteopathic treatment coupled with lactation consultations on infants' ability to latch. The protocol for this trial is presented herein. The trial took place in a mother-to-mother support group, where LCs provided lactation consultations three days a week, free of charge for parents²⁵.

Assessment tools for the trial included 1) the LATCH Assessment Tool to measure the main aspects of the biomechanics of suckling²⁶; 2) a VAS to assess the mother's nipple pain; 3) a goniometer, a soft plastic instrument to measure the rotation of the infant's head's angles; and 4) de novo questionnaires to assess the mother's perception of her infant's ability to latch, as well as sociodemographic data and potential intervention side-effects.

The LATCH Assessment Tool was chosen amongst several others for its specific assessment of the biomechanics of the suckling structures and the global ability of the mother-infant dyad to position themselves comfortably²⁷. While breastfeeding assessment tools are currently discussed in the international lactation community^28,29, the tool is easy to use in the clinic, reliable, and widely implemented among this community to detect early breastfeeding difficulties³⁰. The choice of the tool also enables comparisons with other studies on breastfeeding. Each letter in "LATCH" corresponds to an item to assess an element of the biomechanics of suckling. "L" is for the ability of the infant's tongue, jaws, and lips to sustain the actions and vacuum, and to activate the milk let-down reflex efficiently (Latch). "A" is for Audible swallowing as it is evidence of suckling effectiveness, "T" is for the Type of the nipple at the end of the feed (inverted, flat, or everted), "C" is for the Comfort of the breast and nipple, and "H" is for the assessment of the ease with which the infant is Held in a comfortable and effective position at the breast. The result is a five-item score out of 10 (normal is 10 out of 10) with an interrater reliability of 0.94^31,32.

The VAS is a 10 cm line to estimate the severity of pain felt by mothers, from 0 (no pain) to 10 (maximum pain). For this trial, the VAS was completed at the beginning of the feed, once the infant was latching on, and once the milk let-down had started.

A soft plastic goniometer was used to assess the passive rotation of the infant's head, as described by Cheng³³. Assessments were completed immediately before and following the osteopathic assessment for the control group, and before the assessment and following the osteopathic treatment in the treatment group. Intrarater reliability has been reported to range from 0.83 to 0.98 for the head rotation assessment³⁴.

Finally, a standardized assessment grid was completed by the osteopath for every infant involved in the study, documenting all of the areas exhibiting osteopathic lesions. Osteopathic lesions are areas with lack of mobility or motility, with excess rigidity, or with a lack of tone in the structure. Lesions are classified in three levels of severity, ranging from a structure with limited mobility to a stiff structure with no mobility. In the osteopathic treatment group, all structures addressed during the treatment were documented (Table 1).

Data were analyzed with an intention-to-treat analysis using descriptive statistics. Chi-square tests were used to explore potential correlations between all identified lesion sites and a one-point or more improvement on the LATCH Assessment Tool.

Protocol

This randomized controlled trial protocol was approved by the Comité d’éthique et de la recherche en santé de L’humain at the Centre hospitalier Universitaire de Sherbrooke and the Comité d’éthique et de la recherche at the Centre intégré de santé et services sociaux de la Capitale Nationale in Québec City, Canada. 1. Identification of Collaborators and the Preparation of Recruitment Network with LCs and/or a local moth…

Representative Results

Ninety-seven mother-infant dyads were recruited and randomly assigned to one of the two study groups. The participants' characteristics and delivery mode are summarized in Table 2. Only 1/3 had a natural birth, meaning that the other 2/3 experienced epidural and vacuum (15.9%), forceps-assisted (2.9%), or C-section (18.8%) births. In this study, all infants had skull lesions (Table 3). The posterior quarter represented by the occipital and the tempora…

Discussion

This study is one of the first randomized controlled trials to assess the efficacy of an osteopathic treatment for infants with biomechanical suckling difficulties. When performed promptly, this intervention might reduce the risk of stopping breastfeeding earlier than originally intended.

With no prior models, this trial was designed pragmatically, including the need to act quickly to address breastfeeding difficulties and nipple pain that may be experienced with a newborn. The protocol also m…

Materials

sofa or armchair			comfortable enough for a new mother with potential ceasarean section scar to stay half an hour with the infant in her arms and comfortable enough for the osteopath to perform the intervention
cushion			to put the infant on it and helpful if required,  to breastfeed the infant
Goniometer	Dufort et Lavigne or similar	ALM 324000	in smooth plastic, not too long to be handle with one hand