Physical Therapy Intervention for Puerperal Mastitis

NCT04569136 | Completed Results

• 1 other identifier: MOST 109-2314-B-006-041-MY3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Puerperal mastitis is one of the most commonly reported problems during breastfeeding. Women frequently report breast pain, tenderness, redness, engorgement, fever, malaise, chills, lethargy, sweating, headache, nipple damage and a hot spot on the affected breast. These highly distressing symptoms may severely impact on a woman's daily activities and quality of life and might lead to the premature cessation of exclusive breastfeeding, which may have significant impact on infant health and survival. The role of physical therapy in reducing pregnancy/postpartum-related disorders including breast problems is gaining momentum and importance in obstetrics. However, to date, only low-level evidence has shown positive effects of breast massage, a physical technique, on pain, milk supply and symptom relief in women with breastfeeding problems. This is encouraging, however further research is needed to explore whether physical therapy is effective to reduce symptoms of puerperal mastitis. The investigators will conduct a prospective, assessor blinded single-center randomized controlled trial to assess the effectiveness of an individualized physical therapy program with therapeutic ultrasound, education and massage for patients with puerperal mastitis, compared to patients receiving usual obstetric care and sham ultrasound treatment.

Conditions

Mastitis

Outcome Measures

Primary Outcomes (1)

• Breast and Nipple Pain

  Breast and nipple pain in the past 24 hours will be assessed using the numerical rating scale (NRS). Participants will be asked to rate her breast pain and nipple pain from 0 to 10 (11 point scale), with 0 indicating no pain and 10 indicating the worst possible pain.

  3 months

Secondary Outcomes (7)

• Severity of Breast Engorgement

  3 months

• Breast Hardness

  3 months

• Body and Breast Temperature

  3 months

• Volume of Mother's Milk

  3 months

• Acceptability of the Intervention Program

  3 months

Study Arms (3)

Intervention group

EXPERIMENTAL

* Educating the patient about mastitis and self-management strategies * Treating with therapeutic ultrasound * Administering and teaching breast massage

Other: Education; Other: Therapeutic ultrasound; Other: Breast massage

Sham group

SHAM COMPARATOR

* Educating the patient about mastitis and self-management strategies * Receiving sham ultrasound * Administering and teaching breast massage

Other: Education; Other: Sham ultrasound; Other: Breast massage

Usual care group

OTHER

Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff

Other: Usual obstetric care

Interventions

Education OTHER

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.

Intervention group; Sham group

Therapeutic ultrasound OTHER

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.

Intervention group

Sham ultrasound OTHER

Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.

Sham group

Breast massage OTHER

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.

Intervention group; Sham group

Usual obstetric care OTHER

Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.

Usual care group

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have given birth at National Cheng Kung University Hospital (NCKUH)
• Are Breastfeeding
• Are aged 21-35
• Are diagnosed with early stage mastitis
• Have sufficient Chinese/Mandarin language skills to participate

You may not qualify if:

• History of breast reduction or augmentation
• An abscess
• Severe physical/psychiatric impairments
• Presence of any malignancies

Sponsors & Collaborators

• National Cheng Kung University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University

Tainan, 704, Taiwan

Location

Related Publications (14)

• 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.

  PMID: 30481473 BACKGROUND

• 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.

  PMID: 9874409 BACKGROUND

• 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.

  PMID: 23449233 BACKGROUND

• 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.

  PMID: 25026196 BACKGROUND

• 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.

  PMID: 26644422 BACKGROUND

• 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. Erratum In: Phys Ther. 2007 Sep;87(9):1258.

  PMID: 17553923 BACKGROUND

• 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.

  PMID: 22588748 BACKGROUND

• Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.

  PMID: 7619260 BACKGROUND

• 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.

  PMID: 26885074 BACKGROUND

• Geissler NJ. An instrument used to measure breast engorgement. Nurs Res. 1967 Spring;16(2):130-6. No abstract available.

  PMID: 5181912 BACKGROUND

• 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.

  PMID: 28646371 BACKGROUND

• 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.

  PMID: 21651612 BACKGROUND

• 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.

  PMID: 11517200 BACKGROUND

• 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.

  PMID: 37964187 DERIVED

MeSH Terms

Conditions

Mastitis

Interventions

Educational Status; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Diathermy; Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Dr. Kuan-Yin Lin
• Organization: National Cheng Kung University

10802003@gs.ncku.edu.tw

+886-6-2353535

Study Officials

• Kuan-Yin Lin, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: December 1, 2020
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)