None listed
Conditions
Brief summary
Inflammatory conditions of the lactating breast (ICLB) can affect up to 33% of breastfeeding mothers in the early post-partum period and are associated with pain, redness, flu-like symptoms, and fever. Physiotherapy intervention has an important role in the treatment of ICLB, which most commonly includes therapeutic ultrasound (TUS). TUS can produce heat and other non-thermal effects through sound wave energy which may assist in resolution of ICLB by reducing inflammation, accelerating tissue healing, clearing blocked ducts and other antimicrobial properties. Breastmilk contains numerous important components that combine to create the optimal nutritional source for infants. The most abundant of these components include water (87%), lactose (7%), fat (4%) and protein (1%). As TUS generates heat in the lactating breast, there is concern from Physiotherapists providing TUS and the mothers receiving it, that breastmilk composition may be affected. This is a quasi-experimental study with pre-post measures taken in a single session. Mothers will provide hand expressed breast milk samples pre and post application of continuous therapeutic ultrasound at 1MHz and at the highest clinically used intensity within Australia of 2.2Wcm2. Protein (g/L), lactose (g/L) and fat (g/L) concentrations will be analysed from the milk samples collected before and after TUS. The primary hypothesis of this study is that protein, lactose and fat concentrations within breastmilk will not change significantly before and after the application of TUS to the breast.
Interventions
Therapeutic ultrasound:
Therapeutic ultrasound (Chattanooga, model: Intelect Advanced 2772MC, Austin, Texas, USA) will delivered by one of the researchers using a 5cm2 soundhead, with consistent, light pressured, overlapping and linear strokes for 10 minutes. It will be delivered closely adjacent to the nipple from a superolateral to inferomedial direction. Continuous ultrasound at 1MHz will be utilised and the median of the clinically used intensity within Australia of 1.8Wcm2 will be tested.
Therapeutic ultrasound: Therapeutic ultrasound (Chattanooga, model: Intelect Advanced 2772MC, Austin, Texas, USA) will delivered by one of the researchers using a 5cm2 soundhead, with consistent, light pressured, overlapping and linear strokes for 10 minutes. It will be delivered closely adjacent to the nipple from a superolateral to inferomedial direction. Continuous ultrasound at 1MHz will be utilised and the median of the clinically used intensity within Australia of 1.8Wcm2 will be tested. The frequency of ultrasound therapy will be a single session only. The intervention session will be of approximately 30 minutes duration, consisting of the provision of 2 milk samples (pre and post ultrasound therapy) and a singular, 10 minute session of therapeutic ultrasound. Monitoring of adherence will not be required, as it is single session only. Mothers interested in participating in the study will be screened for eligibility via a Qualtrics survey sent by email which will contain a link to the participation information document detailing the research and their potential role and informed consent will be gained. Data collection will occur in an enclosed room within a church building in Kewdale, Western Australia (WA). A qualified physiotherapist, who has undergone undergraduate training in this modality and has had many hours of clinical experience using therapeutic ultrasound as a treatment modality, will deliver it to all participants.
Sponsors
Curtin University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
English-speaking mothers aged over 18 whose infants are aged between 1-6 months, who are fully breastfeeding (i.e. not pumping more than twice a day).
Exclusion criteria
Mothers who are mixed feeding (i.e. with formula or solids) or have a history and/or current inflammatory condition of the lactating breast will be excluded. Women who have a current pregnancy; known or suspected cancer; circulation problems; bleeding disorders; acute infection; disease of the nervous system; heart condition or cardiac pacemaker and any other electronic, metallic or breast implants will be excluded as they will be ineligible to receive therapeutic ultrasound.
Outcome results
None listed