Clinical trial NCT05132426: Osteopathic Manipulative Treatment for Recurrent Mastitis
Official title: Osteopathic Manipulative Treatment for Recurrent Mastitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mastitis
Keywords: OMT
Mastitis
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial in which there will be a sham OMT control group and an OMT intervention group with a parallel group design.
Primary purpose: PREVENTION

Brief summary: This study will investigate whether Osteopathic Manipulative Treatment (OMT) is effective in treating recurrent mastitis without the use of antibiotics and if it helps in preventing future recurrence of mastitis in individuals who have had multiple occurrences of mastitis.

Detailed description: Lactational mastitis is a significant health issue for breastfeeding women, affecting up to 33% of this population. Mastitis is the most common reason cited for breastfeeding cessation among breastfeeding women. It is commonly treated with antibiotics, and some women will require multiple courses for recurrent episodes, which can lead to antibiotic resistance in the environment. The etiology of mastitis is incompletely defined in the literature, with sources describing an infectious or inflammatory condition. Osteopathic philosophy adds to this differential an examination of the musculoskeletal system, looking for a structure/function relationship. In this light, mastitis might be seen as a problem in the lymphatic system. An osteopathic physician would evaluate a patient for the presence of dysfunction in the fascial structures which drain the breast, and then apply osteopathic manipulative treatment (OMT) to address those dysfunctions. In patients with recurrent mastitis these dysfunctions in the fascia create an environment where impaired drainage leads to repeated episodes. The incorporation of OMT into those conservative treatments is proposed to improve the lymphatic drainage of the breast and therefore eliminate the need for antibiotic treatments. This study will investigate whether OMT is effective in treating recurrent mastitis without antibiotics, and in preventing future recurrence of mastitis in the same breast.

This will be a comparative effectiveness randomized pilot/feasibility clinical trial. We will be recruiting and treating participants who have had multiple diagnoses of mastitis in the same breast in the past 6 months. Participants must meet all inclusion/exclusion criteria in order to be enrolled in this study. Participants who are eligible for this study will undergo a standardized osteopathic examination that will be performed to evaluate connective tissue structures which drain the lymphatic system of the breast. The doctor will be looking for signs of somatic dysfunction which is described as changes in normal tissue qualities or body function that can be affected by osteopathic manipulation to improve health. Once somatic dysfunction is confirmed, patients will be randomly assigned to the sham-control group or the OMT intervention group. Both groups in the study will receive 24-48 hours of standard treatment for recurrent mastitis from their primary or referring physicians such as pain reduction, warm compresses, as well as management of overproduction of milk. If there are no improvements, then antibiotics may be given by their primary physician. If they are in the treatment group they will continue standard treatment but will also undergo OMT including myofascial release of the thoracic inlet, pectoral traction, diaphragm release with MFR, fascial release of the breast, and the thoracic lymphatic pump. If they are enrolled in the sham-control group they will receive sham treatments that will resemble the actual treatments but are not meant to be therapeutic. Both groups will be treated 3 times over 4 weeks, on week 1, week 2, and week 4. These treatments will be done by trained osteopathic physicians and medical students who are members of our osteopathic fellowship program.

Participants in both groups will be asked to take a global health assessment measured by the SF-36 (36-item Short Form Survey/RAND). This is a 36 question survey that will help to measure overall health outcomes during the entirety of the study. This will be taken at Day 0, the week 1 visit, the week 2 visit, the week 4 visit, and at the six-month follow up. In addition, after the initial visit, subjects will be asked to report if and when they have a recurrence of mastitis at any time during the course of the study, if and when they were unable to continue breastfeeding over the course of the study, and they will be asked to report if they experience any adverse effects from the treatment they receive. These data points will be taken at every visit and subjects will be asked to report any such instances to the research assistant if anything is experienced between research visits. The primary comparison will be standard treatment for recurrent mastitis patients with OMT sham versus standard treatment with the addition of OMT for recurrent mastitis patients.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 50 years old.
* Signed an informed consent form.
* Clinical diagnosis of recurrent mastitis: more than 2 episodes of lactational mastitis in the same breast in a 6-month time period.
* Evidence of somatic dysfunction upon undergoing an osteopathic structural exam.

Exclusion Criteria:

* Mammary abscesses.
* Health problems related to pregnancy.
* Inability to receive OMT due to open wounds, fractures, anuresis, necrotizing fasciitis, congestive heart failure, or unstable cardiac conditions.
* Less than 18 years of age or more than 50 years of age.

Primary outcomes:
measure: Recurrence of Mastitis in the sham-control group versus the OMT intervention group.
timeFrame: 6 months
Secondary outcomes:
measure: Global Health Assessment (SF-36 Survey) scores between the sham-control group and the OMT intervention group.
timeFrame: 6 months
measure: Continuation of breastfeeding between the sham-control group and the OMT intervention group.
timeFrame: 6 months
measure: Evaluation of Safety based on adverse events between the sham-control group and the OMT intervention group.
timeFrame: 6 months
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
Study officials:
References: