Therapeutic ultrasound treatment for women with inflammatory conditions of the lactating breast

INTERVENTION: Therapeutic ultrasound plus a standard treatment. Arm 1: High intensity therapeutic ultrasound (2.4 Wcm2). Arm 2: Low intensity therapeutic ultrasound (1 Wcm2). Therapeutic ultrasound (TUS) is non‐invasive cutaneously delivered high frequency ultrasound energy, that is delivered via a sound head that is moving continuously. A women’s health physiotherapist, with 6 years experience of using TUS to treat women with ICLBs, will provide the intervention face‐to‐face at the recruitment sites: 1) A public tertiary women's hospital; 2) a private women's health physiotherapy practice; and 3) the community (at the participant’s home). The physiotherapist is a staff member at recruitment sites 1) and 2). All participants will receive a standard treatment, comprising education and advice addressing ICLB risk factors and the common supportive measures outlined in the literature. In addition, all participants will receive up to 3 consecutive days of TUS treatment to their affected breast, which could be either high intensity TUS (arm 1), low intensity TUS (arm 2) or sham TUS (arm 3: comparator/control). Day 1 of treatment will be prioritised for the same day as recruitment, or as soon as appropriate. A standardised script will be used, asking participants to adhere to the standard treatment and not try different treatments or change what they are doing, and informed consent gained. Participants will be asked to remove clothing covering the breast and will be appropriately positioned lying down and draped with towels, allowing optimal exposure of the affected breast. A hydrogel breast disc will be placed over the nipple, as used in previous breast TUS studies, to protect the nipple and contain any milk ejection during treatment. To mitigate the risk of ov CONDITION: Breast engorgement;Lactational blocked ducts;Lactational mastitis;Breast abscess; ; Breast engorgement ; Lactational blocked ducts ; Lactational mastitis ; Breast abscess Inflammatory and Immune System ‐ Other inflammatory or immune system disorders Reproductive Health and Childbirth ‐ Breast feeding PRIMARY OUTCOME: Size of breast hardness area (in cm2), measured via tracing the area of hardness on to cling wrap with a surgical pen. Cling wrap tracings will be scanned into Adobe and the area calculated electronically. This measures area of local inflammatory symptoms. [Timepoint 1: baseline (day 1, pre intervention).; Timepoint 2: 1 day after intervention commencement (day 2, post intervention).; Timepoint 3: 2 days after intervention commencement (day 3, post intervention) ‐ primary timepoint.; Timepoint 4: 10 days after intervention commencement. ] ; Timepoint 2: 1 day after intervention commencement (day 2, post intervention). ; Timepoint 3: 2 days after intervention commencement (day 3, post intervention). ; Timepoint 4: 10 days after intervention commencement. ] Breast milk sodium and potassium levels as measured by an ion selective electrode (ISE). This is to measure local and systemic inflammatory symptoms. This is a composite secondary outcome. [Timepoint 1: baseline (day 1, pre intervention). ; Timepoint 3: 2 days after intervention commencement (day 3, post intervention). SECONDARY OUTCOME: Acceptability of participating in this study assessed using an online secure survey (REDCap). The survey is designed specifically for this study. [Timepoint 4: 10 days after intervention commencement. ] Acceptability of the primary outcome (size of breast hardness area) assessed using an online secure survey (REDCap). The survey is designed specifically for this study. [Timepoint 4: 10 days after intervention commencement. ] Acceptability of the secondary outcome [1] (breast milk sodium and potassium levels as measured by an ion selective electrode) assessed using an online secure survey (REDCap). The survey is designed specifically for this study. [Timepoint 4: 10 days after intervention commencement. ] Breast Inflammatory Symptom Severity Index (BISSI) scores ‐ a patient reported outcome measure (copyright: Melinda Cooper, physiotherapist), with face and content validity established. This is to measure local and systemic inflammatory symptoms.[Timepoint 1: baseline (day 1, pre intervention). ; Timepoint 4: 10 days after intervention commencement. ] Feasibility of participating in this study assessed using an online secure survey (REDCap). The survey is designed specifically for this study. [Timepoint 4: 10 days after intervention commencement. ] INCLUSION CRITERIA: Lactating women over the age of 18, greater than 7 days postpartum, presenting with; a) at least 1 current local breast inflammatory symptom (e.g. breast pain, redness, increased temperature, swelling) AND b) at least 1 systemic inflammatory symptom (e.g. fever, chills, aching, lethargy, headache) this current episode.