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Osteopathic Manipulative Treatment (OMT) for Mastitis

N/A

Waitlist Available

Research Sponsored by Western University of Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test whether Osteopathic Manipulative Treatment can treat recurrent mastitis without antibiotics, and if it can prevent future occurrences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence of Mastitis

Secondary outcome measures

Continuation of breastfeeding

Evaluation of Safety

Global Health Assessment (SF-36 Survey)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OMT Intervention ArmExperimental Treatment1 Intervention

Myofascial release of the thoracic inlet is a treatment involving gentle pressure applied to shoulders and neck to move the tissue in different directions. Pectoral traction will have the doctor gently grasp and slowly pull the armpit area with a slow pulling force applied towards the shoulders. Diaphragm release with MFR consists of the doctor touching below the ribs on each side and gently applying pressure to move the tissue from side to side. Fascial release of the breast will have the doctor encircling the breast with their hands and inducing anterior traction. The doctor then induces motion in all directions. The doctor will then locate the affected spot and use a direct stripping motion from the base of the breast toward the areola until the restriction is released. Thoracic pump has the doctor placing their hands over the chest wall on each side and applying pressure and releasing pressure several times to generate a pumping action of about 100 times per minute.

Group II: OMT Sham ArmPlacebo Group1 Intervention

MFR of the thoracic inlet Sham: Operator's hands would encircle the thoracic inlet and would feel for somatic dysfunction in the area but would refrain from treating this area. Pectoral traction Sham: The doctor would contact the armpit area and diagnose the somatic dysfunction, but unlike the treatment group they would not do any treatment. Diaphragm release with MFR Sham: The doctor's hands are placed just below the ribcage and will feel for the direct restrictive barriers but will not augment the release. Fascial release of the breast Sham: The doctor would encircle the breast with their hands but would not induce motion or engage any direct barriers. The operator will find the barrier in the tissue but will refrain from treating it. Thoracic pump Sham: The doctor will hold their hands in place over the chest wall but will not try to affect the breathing motion and will not resist the upward motion of the rib cage during inhalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osteopathic Manipulative Treatment (OMT)

2021

Completed Phase 4

~390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Western University of Health SciencesLead Sponsor

23 Previous Clinical Trials

1,299 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research?

"Indeed, the information displayed on clinicaltrials.gov divulges that this research study is currently enrolling participants. The project was initially posted on October 29th 2021 and has been updated recently on November 12th 2021. For its completion, there must be 56 individuals from one site recruited into it."

Answered by AI

Is a recruitment process currently underway for this research study?

"According to the public data at clinicaltrials.gov, this medical experiment is currently accepting participants. It was opened on October 29th 2021 and has undergone a revision as recent as November 12th 2021."

Answered by AI

Are individuals over the age of 40 eligible for this trial?

"The requirements for enrolment in this trial dictate that participants must be between the ages of 18 and 50."

Answered by AI

Is participation in this trial open to individuals such as myself?

"This clinical trial is recruiting 56 individuals aged between 18 and 50 who are suffering from mastitis. Eligible patients must also possess features of somatic dysfunction following a manual osteopathic evaluation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Osteopathic Manipulative Treatment for Recurrent Mastitis

Brian Loveless 2021. "Osteopathic Manipulative Treatment for Recurrent Mastitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05132426.