Clinical trial NCT01643837: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Mastalgia
Keywords: Mastalgia
Breast Pain
Osteopathic Manipulative Medicine
Osteopathic Manipulative Treatment
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Severity of Mastalgia
timeFrame: 30, 60, 90, 120, 210 days
measure: Change from baseline in Duration of Mastalgia
timeFrame: 30, 60, 90, 120, 210 days
measure: Change from baseline in Quality of Life
timeFrame: 30, 60, 90, 120, 210 days
Secondary outcomes:
Other outcomes:
Locations:
city: Central Islip
country: United States
facility: Family Health Care Center
state: New York
city: Old Westbury
country: United States
facility: Academic Health Care Center
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Sharon L Koehler, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: 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.
citation: Hughes LE, Mansel RE, Webster DJT. Breast pain and nodularity. Benign Disorders and Diseases of the Breast. London, England: Saunders 2000:95-121.
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.
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. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16.
citation: Pain JA, Cahill CJ. Management of cyclical mastalgia. Br J Clin Pract. 1990 Nov;44(11):454-6.
citation: Still AT. Osteopathy research and practice. Seattle, WA: Eastland Press; 1992.
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. doi: 10.1056/NEJM199911043411903.
citation: Kuchera W, Kuchera M. Osteopathic principles in practice. 2nd ed. Dayton, OH: Greyden Press; 1994.
citation: Chila AG, et al. Foundations for osteopathic medicine. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2011.
citation: Nelson KE. Somatic dysfunction in osteopathic family medicine. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2007.
citation: Kuchera W, Kuchera M. Osteopathic Considerations in Systemic Dysfunction. revised 2nd ed. Dayton, OH: Greyden Press; 1994.
citation: ACS guidelines http://www.cancer.org/Healthy/FindCancerEarly/CancerScreening Guidelines/american-cancer-society-guidelines-for-the-early-detection-of-cancer. Accessed 5.14.11.
citation: DiGiovanna EL, Schiowitz S, editors. An osteopathic approach to diagnosis and treatment. 2nd ed. Philadelphia, PA: Lippincott-Raven Publishers; 1997.