Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment

Mastalgia Clinical Trial

Official title:

Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01643837
• Other study ID #: BHS-799
• Status: Withdrawn
• Phase: N/A
• Start date: May 7, 2012
• Est. completion date: July 2018

Study information

• Verified date: February 2022
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mastalgia
• Mastodynia

Intervention

Other:
• Osteopathic Manipulative Treatment
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 Light Touch Protocol (LT)
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

Locations

Country	Name	City	State
United States	Family Health Care Center	Central Islip	New York
United States	Academic Health Care Center	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (16)

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

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. — View Citation

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. — View Citation

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

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

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

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. — View Citation

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

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

Millet AV, Dirbas FM. Clinical management of breast pain: a review. Obstet Gynecol Surv. 2002 Jul;57(7):451-61. Review. — View Citation

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

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. — View Citation

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

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

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. Epub 2007 May 16. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Severity of Mastalgia		30, 60, 90, 120, 210 days
Primary	Change from baseline in Duration of Mastalgia		30, 60, 90, 120, 210 days
Primary	Change from baseline in Quality of Life		30, 60, 90, 120, 210 days