MastalgiaNCT01643837
Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment
A study testing Osteopathic Manipulative Treatment and Osteopathic Manipulative Light Touch Protocol (LT) in people with Mastalgia, run by New York Institute of Technology at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastalgia
- What is being tested?
- Osteopathic Manipulative Treatment and Osteopathic Manipulative Light Touch Protocol (LT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2012to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Health Care Center
Central Islip, New York, 11722
Academic Health Care Center
Old Westbury, New York, 11568
About this study
Official title: Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?
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.
Read the 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.
- Conditions
- Mastalgia
- Being tested
- Osteopathic Manipulative Treatment, Osteopathic Manipulative Light Touch Protocol (LT)
- Keywords
- Mastalgia, Breast Pain, Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Severity of Mastalgia
Measured: 30, 60, 90, 120, 210 days
Change from baseline in Duration of Mastalgia
Measured: 30, 60, 90, 120, 210 days
Change from baseline in Quality of Life
Measured: 30, 60, 90, 120, 210 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study start7 May 2012
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: unable to free investigators; time constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for MastalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon L Koehler, DO, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643837
- Sponsor's protocol ID
- BHS-799
- Status last verified
- Feb 2022
- First submitted
- 10 Jul 2012
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12243507Rosolowich 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.
PubMed 16533457Ader 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.
PubMed 9240595Nichols 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.
PubMed 7437833Hughes LE, Mansel RE, Webster DJT. Breast pain and nodularity. Benign Disorders and Diseases of the Breast. London, England: Saunders 2000:95-121.
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.
PubMed 12172222Srivastava 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.
PubMed 17509880Pain JA, Cahill CJ. Management of cyclical mastalgia. Br J Clin Pract. 1990 Nov;44(11):454-6.
PubMed 2282296Still AT. Osteopathy research and practice. Seattle, WA: Eastland Press; 1992.
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.
PubMed 10547405Kuchera W, Kuchera M. Osteopathic principles in practice. 2nd ed. Dayton, OH: Greyden Press; 1994.
Chila AG, et al. Foundations for osteopathic medicine. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2011.
Nelson KE. Somatic dysfunction in osteopathic family medicine. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2007.
Kuchera W, Kuchera M. Osteopathic Considerations in Systemic Dysfunction. revised 2nd ed. Dayton, OH: Greyden Press; 1994.
ACS guidelines http://www.cancer.org/Healthy/FindCancerEarly/CancerScreening Guidelines/american-cancer-society-guidelines-for-the-early-detection-of-cancer. Accessed 5.14.11.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?
- ClinicalTrials.gov ID
- NCT01643837
- Acronym / sponsor ID
- BHS-799
- Conditions
- Mastalgia
- Keywords
- Mastalgia, Breast Pain, Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to free investigators; time constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 7 May 2012 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. |
| Light Touch (LT) | Sham comparator | Other: Osteopathic Manipulative Light Touch Protocol (LT)Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. Light touch protocol. |
| Osteopathic Manipulative Treatment (OMT) | Experimental | Other: Osteopathic Manipulative TreatmentStandard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. OMT Protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentOMT - 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 | Other | Osteopathic Manipulative Treatment (OMT) |
| 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 | Other | Light Touch (LT) |
Primary outcome
Change from baseline in Severity of Mastalgia
Time frame: 30, 60, 90, 120, 210 days
Change from baseline in Duration of Mastalgia
Time frame: 30, 60, 90, 120, 210 days
Change from baseline in Quality of Life
Time frame: 30, 60, 90, 120, 210 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 12243507Khan 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.
- Background: PubMed 16533457Rosolowich 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.
- Background: PubMed 9240595Ader 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.
- Background: PubMed 7437833Nichols 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.
- BackgroundHughes LE, Mansel RE, Webster DJT. Breast pain and nodularity. Benign Disorders and Diseases of the Breast. London, England: Saunders 2000:95-121.
- Background: PubMed 12172222Millet 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.
- Background: PubMed 17509880Srivastava 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.
- Background: PubMed 2282296Pain JA, Cahill CJ. Management of cyclical mastalgia. Br J Clin Pract. 1990 Nov;44(11):454-6.
- BackgroundStill AT. Osteopathy research and practice. Seattle, WA: Eastland Press; 1992.
- Background: PubMed 10547405Andersson 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.
- BackgroundKuchera W, Kuchera M. Osteopathic principles in practice. 2nd ed. Dayton, OH: Greyden Press; 1994.
- BackgroundChila AG, et al. Foundations for osteopathic medicine. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Koehler, DO principal investigator
New York Institute of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment and Osteopathic Manipulative Light Touch Protocol (LT) in people with Mastalgia, run by New York Institute of Technology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Severity of Mastalgia (time frame: 30, 60, 90, 120, 210 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643837, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.