Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2020-12-01
2023-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
* Educating the patient about mastitis and self-management strategies
* Treating with therapeutic ultrasound
* Administering and teaching breast massage
Education
The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.
Therapeutic ultrasound
Participants will be treated with 5 minutes of therapeutic ultrasound (pulsed mode) at a frequency of 1 Mega Hertz, a duty cycle of 20%, a pulse intensity of 1.8 Watt/centimetre squared. The ultrasound probe will be moved at a speed of about 4 centimetre/second. The intensity and duration will be adjusted if the patient complains of discomfort. The ultrasound transducer head will massage over the tender point on the breast.
Breast massage
Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.
Sham group
* Educating the patient about mastitis and self-management strategies
* Receiving sham ultrasound
* Administering and teaching breast massage
Education
The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.
Sham ultrasound
Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
Breast massage
Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.
Usual care group
Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff
Usual obstetric care
Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.
Interventions
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Education
The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.
Therapeutic ultrasound
Participants will be treated with 5 minutes of therapeutic ultrasound (pulsed mode) at a frequency of 1 Mega Hertz, a duty cycle of 20%, a pulse intensity of 1.8 Watt/centimetre squared. The ultrasound probe will be moved at a speed of about 4 centimetre/second. The intensity and duration will be adjusted if the patient complains of discomfort. The ultrasound transducer head will massage over the tender point on the breast.
Sham ultrasound
Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
Breast massage
Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.
Usual obstetric care
Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.
Eligibility Criteria
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Inclusion Criteria
* Are Breastfeeding
* Are aged 21-35
* Are diagnosed with early stage mastitis
* Have sufficient Chinese/Mandarin language skills to participate
Exclusion Criteria
* An abscess
* Severe physical/psychiatric impairments
* Presence of any malignancies
21 Years
35 Years
FEMALE
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
National Cheng Kung University
OTHER
Responsible Party
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Kuan-Yin Lin
Assistant professor
Principal Investigators
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Kuan-Yin Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cheng Kung University
Locations
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National Cheng Kung University
Tainan City, , Taiwan
Countries
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References
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Diepeveen LC, Fraser E, Croft AJE, Jacques A, McArdle AM, Briffa K, McKenna L. Regional and Facility Differences in Interventions for Mastitis by Australian Physiotherapists. J Hum Lact. 2019 Nov;35(4):695-705. doi: 10.1177/0890334418812041. Epub 2018 Nov 27.
Kasseroller RG. The Vodder School: the Vodder method. Cancer. 1998 Dec 15;83(12 Suppl American):2840-2. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-5.
Lavigne V, Gleberzon BJ. Ultrasound as a treatment of mammary blocked duct among 25 postpartum lactating women: a retrospective case series. J Chiropr Med. 2012 Sep;11(3):170-8. doi: 10.1016/j.jcm.2012.05.011.
McLachlan Z, Milne EJ, Lumley J, Walker BL. Ultrasound treatment for breast engorgement: A randomised double blind trial. Aust J Physiother. 1991;37(1):23-8. doi: 10.1016/S0004-9514(14)60531-6.
Witt AM, Bolman M, Kredit S, Vanic A. Therapeutic Breast Massage in Lactation for the Management of Engorgement, Plugged Ducts, and Mastitis. J Hum Lact. 2016 Feb;32(1):123-31. doi: 10.1177/0890334415619439. Epub 2015 Dec 7.
Wong RA, Schumann B, Townsend R, Phelps CA. A survey of therapeutic ultrasound use by physical therapists who are orthopaedic certified specialists. Phys Ther. 2007 Aug;87(8):986-94. doi: 10.2522/ptj.20050392. Epub 2007 Jun 6.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.
Lim AR, Song JA, Hur MH, Lee MK, Lee MS. Cabbage compression early breast care on breast engorgement in primiparous women after cesarean birth: a controlled clinical trial. Int J Clin Exp Med. 2015 Nov 15;8(11):21335-42. eCollection 2015.
Geissler NJ. An instrument used to measure breast engorgement. Nurs Res. 1967 Spring;16(2):130-6. No abstract available.
Mori H, Uemura N, Koga H, Okazaki M. Objective assessment of reconstructed breast hardness using a durometer. Breast Cancer. 2018 Jan;25(1):81-85. doi: 10.1007/s12282-017-0791-y. Epub 2017 Jun 23.
Teran CG, Torrez-Llanos J, Teran-Miranda TE, Balderrama C, Shah NS, Villarroel P. Clinical accuracy of a non-contact infrared skin thermometer in paediatric practice. Child Care Health Dev. 2012 Jul;38(4):471-6. doi: 10.1111/j.1365-2214.2011.01264.x. Epub 2011 Jun 8.
Jones E, Dimmock PW, Spencer SA. A randomised controlled trial to compare methods of milk expression after preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F91-5. doi: 10.1136/fn.85.2.f91.
Lin KY, Shao W, Tsai YJ, Yang JF, Wu MH. Physical therapy intervention for breast symptoms in lactating women: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Nov 14;23(1):792. doi: 10.1186/s12884-023-06114-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Study Documents
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Document Type: Clinical Study Report
View DocumentOther Identifiers
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MOST 109-2314-B-006-041-MY3
Identifier Type: -
Identifier Source: org_study_id
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