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

Therapeutic ultrasound plus a standard treatment. Arm 1: High intensity therapeutic ultrasound (2 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 over 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) private women's health physiotherapy practices; and 3) the community (at the participant’s home). The physiotherapist is a staff member at recruitment site 1) and at one of recruitment sites 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. To mitigate the risk of overheating, intact sensation will be confirmed prior to TUS application and participants will be given a TUS standard warnings and safety summary sheet prior to and for reference throughout the intervention. The physiotherapist will have 1 TUS machine (Astar Physiogo 300) with 3 sound heads clearly labelled A, B or C. These will correspond to pre-set programs (A, B and C) on the TUS machine. One program will be set to deliver high intensity TUS (2 Wcm2), one to deliver low intensity TUS (1 Wcm2) and one to deliver sham TUS. This will be done by a non-trial member and the sham sound head will be altered by the electrophysical company prior to the physiotherapist receiving them, thus, blinding both the physiotherapist and participant to the intervention. The physiotherapist will be able to turn down the intensity for safety. Active TUS will be applied at 1 MHz frequency in continuous mode, reflective of the majority of Australian physiotherapy practice. Aqueous gel will be placed on the 4 cm2 sound head and the physiotherapist will apply the TUS over the area of breast swelling/hardness/tightness, using consistent light pressure and overlapping linear strokes, extending towards the axilla and nipple. Participants will be instructed not to inform the physiotherapist if they feel heat, to maintain blinding, unless it becomes more than a comfortable warmth. Duration of application will be dependent on the size of the affected area, which will be measured using the sound head, prior to TUS application. Areas of up to and including 8 cm2 (2 ultrasound heads) will receive 10 minutes of treatment; areas of greater than 8 cm2 and less than 16 cm2 (within 3 sound heads) will receive 15 minutes; and areas of 16 cm2 (4 sound heads) or greater, will receive 20 minutes of TUS treatment. The standard treatment will be delivered via 3 different mediums: 1) video: 3-4 minutes duration, played for participants on a tablet during day 1 TUS intervention (the video will be on the trial's website for participant's later reference); 2) hard paper copy: As an infographic, with a) a laminated copy for participants to view on day 1 during the intervention and b) a pamphlet for them to take home; and 3) electronic copy of the infographic (on the trial's website; the URL will be given to all participants). The educational material/infographic is designed specifically for this study. Participants will be encouraged to breastfeed or express prior to the intervention, to ensure their breasts are as soft as possible, and then again as soon as possible/comfortable (or within 20 to 30 minutes) post intervention. Intervention fidelity will be assessed via an online secure survey (REDCap) comprising yes/no and slider scale questions checking compliance with the different aspects of the standard treatment, and an open text response question asking about any additional treatments used/trialled. Participants will use a QR code or customised email link to access their survey. Four extra slider scale and accompanying open text questions will be included in the survey at the end of the intervention, asking participants about their satisfaction and experience with aspects of the trial (see secondary outcomes). Participants may be contacted at 3 and 6 months post their participation in the trial, via email or phone, to ask a few questions about ICLB recurrences.