Osteopathic Manipulative Treatment for Recurrent Mastitis

NCT05132426 | Withdrawn

• 1 other identifier: FB21/IRB/060
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastitis

Keywords

OMT; Mastitis

Outcome Measures

Primary Outcomes (1)

• Recurrence of Mastitis in the sham-control group versus the OMT intervention group.

  Comparing the number of individuals who have a recurrence of mastitis in the sham-control group versus the OMT intervention group.

  6 months

Secondary Outcomes (3)

• Global Health Assessment (SF-36 Survey) scores between the sham-control group and the OMT intervention group.

  6 months

• Continuation of breastfeeding between the sham-control group and the OMT intervention group.

  6 months

• Evaluation of Safety based on adverse events between the sham-control group and the OMT intervention group.

  6 months

Study Arms (2)

OMT Intervention Arm

EXPERIMENTAL

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.

Procedure: Osteopathic Manipulative Treatment (OMT)

OMT Sham Arm

SHAM COMPARATOR

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.

Procedure: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

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.

OMT Intervention Arm; OMT Sham Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University of Health Sciences: lead

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

MeSH Terms

Conditions

Mastitis

Interventions

Manipulation, Osteopathic

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)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be told whether they are enrolled in the OMT intervention group or the OMT Sham Group (placebo group). Investigators will be blinded to which participants are in each group and will collect data using only subject numbers provided on labels. Outcomes assessors will analyze data with coded patient data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: October 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)