NCT01643837

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

6.2 years

First QC Date

July 10, 2012

Last Update Submit

February 1, 2022

Conditions

Mastalgia

Keywords

MastalgiaBreast PainOsteopathic Manipulative MedicineOsteopathic Manipulative Treatment

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in Severity of Mastalgia

    30, 60, 90, 120, 210 days

  • Change from baseline in Duration of Mastalgia

    30, 60, 90, 120, 210 days

  • Change from baseline in Quality of Life

    30, 60, 90, 120, 210 days

Study Arms (3)

Standard

NO INTERVENTION

Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.

Light Touch (LT)

SHAM COMPARATOR

Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. Light touch protocol.

Other: Osteopathic Manipulative Light Touch Protocol (LT)

Osteopathic Manipulative Treatment (OMT)

EXPERIMENTAL

Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. OMT Protocol.

Other: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative TreatmentOTHER

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

Osteopathic Manipulative Treatment (OMT)
Osteopathic Manipulative Light Touch Protocol (LT)OTHER

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

Light Touch (LT)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Health Care Center

Central Islip, New York, 11722, United States

Location

Academic Health Care Center

Old Westbury, New York, 11568, United States

Location

Related Publications (16)

  • Khan SA, Apkarian AV. The characteristics of cyclical and non-cyclical mastalgia: a prospective study using a modified McGill Pain Questionnaire. Breast Cancer Res Treat. 2002 Sep;75(2):147-57. doi: 10.1023/a:1019685829799.

    PMID: 12243507BACKGROUND

  • Rosolowich V, Saettler E, Szuck B; BREAST DISEASE COMMITTEE. RETIRED: Mastalgia. J Obstet Gynaecol Can. 2006 Jan;28(1):49-57. doi: 10.1016/S1701-2163(16)32027-8. English, French.

    PMID: 16533457BACKGROUND

  • 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.

    PMID: 9240595BACKGROUND

  • Nichols S, Waters WE, Wheeler MJ. Management of female breast disease by Southampton general practitioners. Br Med J. 1980 Nov 29;281(6253):1450-3. doi: 10.1136/bmj.281.6253.1450.

    PMID: 7437833BACKGROUND

  • Hughes LE, Mansel RE, Webster DJT. Breast pain and nodularity. Benign Disorders and Diseases of the Breast. London, England: Saunders 2000:95-121.

    BACKGROUND

  • 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.

    PMID: 12172222BACKGROUND

  • Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16.

    PMID: 17509880BACKGROUND

  • Pain JA, Cahill CJ. Management of cyclical mastalgia. Br J Clin Pract. 1990 Nov;44(11):454-6.

    PMID: 2282296BACKGROUND

  • Still AT. Osteopathy research and practice. Seattle, WA: Eastland Press; 1992.

    BACKGROUND

  • Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.

    PMID: 10547405BACKGROUND

  • Kuchera W, Kuchera M. Osteopathic principles in practice. 2nd ed. Dayton, OH: Greyden Press; 1994.

    BACKGROUND

  • Chila AG, et al. Foundations for osteopathic medicine. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2011.

    BACKGROUND

  • Nelson KE. Somatic dysfunction in osteopathic family medicine. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2007.

    BACKGROUND

  • Kuchera W, Kuchera M. Osteopathic Considerations in Systemic Dysfunction. revised 2nd ed. Dayton, OH: Greyden Press; 1994.

    BACKGROUND

  • ACS guidelines http://www.cancer.org/Healthy/FindCancerEarly/CancerScreening Guidelines/american-cancer-society-guidelines-for-the-early-detection-of-cancer. Accessed 5.14.11.

    BACKGROUND

  • DiGiovanna EL, Schiowitz S, editors. An osteopathic approach to diagnosis and treatment. 2nd ed. Philadelphia, PA: Lippincott-Raven Publishers; 1997.

    BACKGROUND

MeSH Terms

Conditions

Mastodynia

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sharon L Koehler, DO

    New York Institute of Technology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 18, 2012

Study Start

May 7, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

US(2)