Back to resultsMastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment
Primary Purpose
Mastalgia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Osteopathic Manipulative Light Touch Protocol (LT)
Sponsored by
About this trial
This is an interventional treatment trial for Mastalgia focused on measuring Mastalgia, Breast Pain, Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment
Eligibility Criteria
Inclusion Criteria:
- Women over 18 years of age presenting with breast pain, both cyclical and noncyclical, who complain of pain despite a negative full work-up for pathology, reassurance, and use of an appropriate supportive bra.
- A pain scale questionnaire will be completed by the subject. The pain should be present for at least 7 days each month if it is mild pain or be of moderate to severe intensity for at least 3 days each month. In addition, breast pain must have been present for a minimum of 2 consecutive months preceding the date of inclusion into the study.
Exclusion Criteria:
- Women under 18 years old, women who have had recent breast surgery (<2yrs), women who have breast implants.
- Women with bleeding risk such as those regularly taking aspirin, NSAIDs, Plavix or any other anticoagulation therapy.
- Women who are pregnant, breastfeeding or who are planning to get pregnant are excluded.
- Women with known chronic pain syndromes or structural abnormality such as osteoporosis will be excluded. When necessary bone densitometry will be performed.
- Women who are unable to complete the questionnaire.
Sites / Locations
- Family Health Care Center
- Academic Health Care Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Sham Comparator
Experimental
Arm Label
Standard
Light Touch (LT)
Osteopathic Manipulative Treatment (OMT)
Arm Description
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. Light touch protocol.
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. OMT Protocol.
Outcomes
Primary Outcome Measures
Change from baseline in Severity of Mastalgia
Change from baseline in Duration of Mastalgia
Change from baseline in Quality of Life
Secondary Outcome Measures
Full Information
NCT ID
NCT01643837
First Posted
July 10, 2012
Last Updated
February 1, 2022
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01643837
Brief Title
Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment
Official Title
Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
unable to free investigators; time constraints
Study Start Date
May 7, 2012 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are many current medical treatments for mastalgia, but few have been proven effective. Our objective is to evaluate the effectiveness of osteopathic manipulative treatment as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia. We will compare duration of the pain, severity of the pain and the effect of the pain on quality of life.
Detailed Description
Our objective is to evaluate the effectiveness of osteopathic manipulative treatment (OMT) as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia (breast pain).
A randomized placebo controlled study will be conducted at two academic health care centers. Women with breast pain will be evaluated and followed by the breast surgeon. Once a pathologic cause has been ruled out, the women will be stratified and randomly divided into three study groups. Group A, B, and C. Group A will receive standard of care treatment. Group B will receive light touch (a placebo for the OMT treatment). Group C will receive OMT directed at treating mastalgia. The treatment will continue for three months.
The subjects will fill out an initial pain questionnaire and a follow-up questionnaire each month. They will also be instructed to fill out a breast pain log daily for three months. A final questionnaire will be completed at six months. Statistical analysis will be utilized to determine whether the addition of OMT improves the severity or duration of the pain as well as quality of life as assessed by the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastalgia
Keywords
Mastalgia, Breast Pain, Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
No Intervention
Arm Description
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.
Arm Title
Light Touch (LT)
Arm Type
Sham Comparator
Arm Description
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.
Light touch protocol.
Arm Title
Osteopathic Manipulative Treatment (OMT)
Arm Type
Experimental
Arm Description
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.
OMT Protocol.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
OMT - Sacral Ligamenotus Articular Release; OMT - Lumbar Spine (L1-L2) and Lower Thoracic Spine (T10-12) Ligamentous Articular Release; OMT - Upper Thoracic Spine Ligamentous Articular Release (T1-T8); OMT - Cervical Spine Ligamentous Articular Release (C5-C7); OMT - Suboccipital Myofascial Release; OMT - Clavicular Ligamentous Articular Release; OMT - First Rib Ligamentous Articular Release; OMT - Ribs 2-8 Ligamentous Articular Release; OMT - Pectoral Pull; OMT - Sternal Ligamentous Articular Release; OMT - Direct Myofascial Release of the Diaphragm; OMT - Thoracic Lymphatic Pump; OMT - Fascial Release of Breast Tissue
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Light Touch Protocol (LT)
Intervention Description
LT - Sacral Region; LT - Lumbar Spine and Lower Thoracic Region; LT - Upper Thoracic Spine Region; LT - Cervical Spine Region; LT - Suboccipital Region; LT - Clavicles; LT - First Ribs; LT - Ribs 2-8; LT - Pectoralis Muscles; LT - Sternum; LT - Respiratory Diaphragm; LT - Upper Thoracic Cage; LT - Lower Thoracic Cage
Primary Outcome Measure Information:
Title
Change from baseline in Severity of Mastalgia
Time Frame
30, 60, 90, 120, 210 days
Title
Change from baseline in Duration of Mastalgia
Time Frame
30, 60, 90, 120, 210 days
Title
Change from baseline in Quality of Life
Time Frame
30, 60, 90, 120, 210 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women over 18 years of age presenting with breast pain, both cyclical and noncyclical, who complain of pain despite a negative full work-up for pathology, reassurance, and use of an appropriate supportive bra.
A pain scale questionnaire will be completed by the subject. The pain should be present for at least 7 days each month if it is mild pain or be of moderate to severe intensity for at least 3 days each month. In addition, breast pain must have been present for a minimum of 2 consecutive months preceding the date of inclusion into the study.
Exclusion Criteria:
Women under 18 years old, women who have had recent breast surgery (<2yrs), women who have breast implants.
Women with bleeding risk such as those regularly taking aspirin, NSAIDs, Plavix or any other anticoagulation therapy.
Women who are pregnant, breastfeeding or who are planning to get pregnant are excluded.
Women with known chronic pain syndromes or structural abnormality such as osteoporosis will be excluded. When necessary bone densitometry will be performed.
Women who are unable to complete the questionnaire.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Koehler, DO
Organizational Affiliation
New York Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Health Care Center
City
Central Islip
State/Province
New York
ZIP/Postal Code
11722
Country
United States
Facility Name
Academic Health Care Center
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12243507
Citation
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Citation
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PubMed Identifier
9240595
Citation
Ader DN, Browne MW. Prevalence and impact of cyclic mastalgia in a United States clinic-based sample. Am J Obstet Gynecol. 1997 Jul;177(1):126-32. doi: 10.1016/s0002-9378(97)70450-2.
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PubMed Identifier
7437833
Citation
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PubMed Identifier
12172222
Citation
Millet AV, Dirbas FM. Clinical management of breast pain: a review. Obstet Gynecol Surv. 2002 Jul;57(7):451-61. doi: 10.1097/00006254-200207000-00022.
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PubMed Identifier
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Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment
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