Postmastectomy Lymphedema SyndromeNCT02250898
Massage for Post Breast Surgery
A study testing Myofascial Massage Therapy and Global Relaxation Massage in people with Postmastectomy Lymphedema Syndrome and Pain, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages. Read more about this study
- Who is it for?
- Ages 21 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmastectomy Lymphedema Syndrome, Pain, Shoulder Mobility Impairment
- What is being tested?
- Myofascial Massage Therapy and Global Relaxation Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2015
- 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 21 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 21-79 years of age
- Female
- Breast and/or axillary surgery
- 2-18 months post-operative
- Meets minimum pain and/or lack of mobility threshold as determined by survey
- Ability to give informed consent
- Ability to complete adherence task
- Benign or malignant forms of disease
Who cannot join
- History of blood clots
- Mentally incompetent
- Non-English speaking
- Infected sites or open wounds
- Currently lactating
- Currently receiving massage therapy for breast surgery
- Currently taking anticoagulants including:
- Cilostazol Clopidogrel Ticlopidine Prasugrel Ticagrelor Dipyridamole Warfarin Dabigatran Rivaroxaban Apixaban Abciximab Eptifibatide Tirofiban Dalteparin Enoxaparin Fondaparinux Heparin Tinzaparin Argatroban Bivalirudin Lepirudin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Massage for Pain and Mobility in Post-Breast Surgery Patients
The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages.
Read the detailed description
Post-operative breast surgery patients may face an array of complications. Breast surgery can include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012). Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and persistent issues in this population, however it is still unclear as to how many actually suffer from these (Wallace 1996). Current treatment for each of these usually includes prescribed narcotic pain medication and/or some physical therapy, the first being a treatment with many side effects, the latter being quite expensive. Global and integrated massage techniques have been used as a way of decreasing stress, anxiety, and some self-reported pain, however a targeted massage technique geared towards the breast/chest/shoulder region has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an effective treatment for other post-surgical patients in reducing pain and increasing mobility, but efficacy has yet to be shown specifically in post-breast surgery patients (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive and non-invasive addition to current pain and mobility treatment (Cassileth 2004).
Specific Aims
Aim A.
Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain among patients who have undergone a mastectomy or other breast surgery.
Aim B.
Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in increasing self-reported mobility in the affected shoulder among patients who have undergone a mastectomy or other breast surgery.
Hypothesis: Compared to control patients receiving general full body massage, myofascial massage specific to the breast/chest/shoulder area reduces pain and increases mobility in patients who have undergone breast surgery.
- Being tested
- Myofascial Massage Therapy, Global Relaxation Massage
- Keywords
- Post Breast Surgery, Myofascial Massage, Pain, Mobility Limitations
- Medical subject headings
- Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Massage TherapyOther
Myofascial Massage Therapy is a manual massage therapy consisting of the following techniques: fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage.
Global Relaxation MassageOther
Global Relaxation Massage is a manual massage therapy consisting of a full body relaxation massage that includes light kneading and stroking in order to restore a sense of well- being
| Study group | Role | What they receive |
|---|---|---|
| Experimental/Myofascial | Experimental | The intervention group will receive Myofascial Massage Therapy specific to breast/chest/shoulder of the affected side(s). These massages will include a variety of techniques specifically aimed at reducing pain, inflammation, and tissue sensitivity while also increasing mobility by breaking up scar tissue and thick fibrosis. The intervention massages will include the following specific techniques: skin glide, j stroking, vertical stroking, strumming, fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. These massages will be twice a week at 30 minutes per massage for a period of 2 months after study enrollment. Receives: Other: Myofascial Massage Therapy |
| Control/Global Relaxation | Active comparator | The control group will receive a general full body massage referred to as a Global Relaxation massage. The massage technique used here will be relaxation massage, avoiding the breast/chest/arm area. This includes light kneading and stroking in order to restore a sense of well- being. The relaxation massage will also be twice a week at 30 minutes per massage for a period of 2 months, avoiding the area of the affected shoulder/shoulders. In this way they are still being seen and touched by a massage therapist, without receiving the intervention treatment. Receives: Other: Global Relaxation Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self reported pain pre and post study
Self report survey of current pain type and intensity will be given at the beginning of enrollment and then again after the 2 month study period ends. Pain scores will be measured pre and post.
Measured: 2 months
Secondary outcomes (1)
Change in self reported mobility pre and post study
Self report survey of current mobility issues and restrictions in relation to the breast/chest/shoulder area will be given at the time of enrollment and after the 2 month study period.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postmastectomy Lymphedema SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ash Sehgal, MetroHealth Medical Center
- Investigators
- Ashwini Sehgal, MD, Principal investigator, Ctr for Reducing Health Disparities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250898
- Sponsor's protocol ID
- IRB13-01052
- Status last verified
- May 2018
- First submitted
- 24 Sep 2014
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9. doi: 10.1016/j.jpainsymman.2003.12.016.
PubMed 15336336Drackley NL, Degnim AC, Jakub JW, Cutshall SM, Thomley BS, Brodt JK, Vanderlei LK, Case JK, Bungum LD, Cha SS, Bauer BA, Boughey JC. Effect of massage therapy for postsurgical mastectomy recipients. Clin J Oncol Nurs. 2012 Apr;16(2):121-4. doi: 10.1188/12.CJON.121-124.
PubMed 22459520Fernandez-Lao C, Cantarero-Villanueva I, Diaz-Rodriguez L, Fernandez-de-las-Penas C, Sanchez-Salado C, Arroyo-Morales M. The influence of patient attitude toward massage on pressure pain sensitivity and immune system after application of myofascial release in breast cancer survivors: a randomized, controlled crossover study. J Manipulative Physiol Ther. 2012 Feb;35(2):94-100. doi: 10.1016/j.jmpt.2011.09.011. Epub 2011 Oct 21.
PubMed 22018755FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
PubMed 19535099Khan 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 12243507Martin ML, Hernandez MA, Avendano C, Rodriguez F, Martinez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011 Mar 9;11:94. doi: 10.1186/1471-2407-11-94.
PubMed 21392372Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
PubMed 8880841
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage for Pain and Mobility in Post-Breast Surgery Patients
- ClinicalTrials.gov ID
- NCT02250898
- Acronym / sponsor ID
- IRB13-01052
- Keywords
- Post Breast Surgery, Myofascial Massage, Pain, Mobility Limitations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Sep 2014 (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.
The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages.
Detailed description
Post-operative breast surgery patients may face an array of complications. Breast surgery can include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012). Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and persistent issues in this population, however it is still unclear as to how many actually suffer from these (Wallace 1996). Current treatment for each of these usually includes prescribed narcotic pain medication and/or some physical therapy, the first being a treatment with many side effects, the latter being quite expensive. Global and integrated massage techniques have been used as a way of decreasing stress, anxiety, and some self-reported pain, however a targeted massage technique geared towards the breast/chest/shoulder region has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an effective treatment for other post-surgical patients in reducing pain and increasing mobility, but efficacy has yet to be shown specifically in post-breast surgery patients (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive and non-invasive addition to current pain and mobility treatment (Cassileth 2004).
Specific Aims
Aim A.
Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain among patients who have undergone a mastectomy or other breast surgery.
Aim B.
Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in increasing self-reported mobility in the affected shoulder among patients who have undergone a mastectomy or other breast surgery.
Hypothesis: Compared to control patients receiving general full body massage, myofascial massage specific to the breast/chest/shoulder area reduces pain and increases mobility in patients who have undergone breast surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental/Myofascial | Experimental | Other: Myofascial Massage TherapyThe intervention group will receive Myofascial Massage Therapy specific to breast/chest/shoulder of the affected side(s). These massages will include a variety of techniques specifically aimed at reducing pain, inflammation, and tissue sensitivity while also increasing mobility by breaking up scar tissue and thick fibrosis. The intervention massages will include the following specific techniques: skin glide, j stroking, vertical stroking, strumming, fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. These massages will be twice a week at 30 minutes per massage for a period of 2 months after study enrollment. |
| Control/Global Relaxation | Active comparator | Other: Global Relaxation MassageThe control group will receive a general full body massage referred to as a Global Relaxation massage. The massage technique used here will be relaxation massage, avoiding the breast/chest/arm area. This includes light kneading and stroking in order to restore a sense of well- being. The relaxation massage will also be twice a week at 30 minutes per massage for a period of 2 months, avoiding the area of the affected shoulder/shoulders. In this way they are still being seen and touched by a massage therapist, without receiving the intervention treatment. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range 21-79 years of age
- Female
- Breast and/or axillary surgery
- 2-18 months post-operative
- Meets minimum pain and/or lack of mobility threshold as determined by survey
Key exclusion criteria (8 listed)
- History of blood clots
- Mentally incompetent
- Non-English speaking
- Infected sites or open wounds
- Currently lactating
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 |
|---|---|---|
| Myofascial Massage TherapyMyofascial Massage Therapy is a manual massage therapy consisting of the following techniques: fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. | Other | Experimental/Myofascial |
| Global Relaxation MassageGlobal Relaxation Massage is a manual massage therapy consisting of a full body relaxation massage that includes light kneading and stroking in order to restore a sense of well- being | Other | Control/Global Relaxation |
Primary outcome
Change in self reported pain pre and post study
Time frame: 2 months
Self report survey of current pain type and intensity will be given at the beginning of enrollment and then again after the 2 month study period ends. Pain scores will be measured pre and post.
1 secondary outcome
Change in self reported mobility pre and post study
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Background: PubMed 15336336Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9. doi: 10.1016/j.jpainsymman.2003.12.016.
- Background: PubMed 22459520Drackley NL, Degnim AC, Jakub JW, Cutshall SM, Thomley BS, Brodt JK, Vanderlei LK, Case JK, Bungum LD, Cha SS, Bauer BA, Boughey JC. Effect of massage therapy for postsurgical mastectomy recipients. Clin J Oncol Nurs. 2012 Apr;16(2):121-4. doi: 10.1188/12.CJON.121-124.
- Background: PubMed 22018755Fernandez-Lao C, Cantarero-Villanueva I, Diaz-Rodriguez L, Fernandez-de-las-Penas C, Sanchez-Salado C, Arroyo-Morales M. The influence of patient attitude toward massage on pressure pain sensitivity and immune system after application of myofascial release in breast cancer survivors: a randomized, controlled crossover study. J Manipulative Physiol Ther. 2012 Feb;35(2):94-100. doi: 10.1016/j.jmpt.2011.09.011. Epub 2011 Oct 21.
- Background: PubMed 19535099FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
- 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 21392372Martin ML, Hernandez MA, Avendano C, Rodriguez F, Martinez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011 Mar 9;11:94. doi: 10.1186/1471-2407-11-94.
- Background: PubMed 8880841Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
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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.
Ashwini Sehgal, MD principal investigator
Ctr for Reducing Health Disparities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Massage Therapy and Global Relaxation Massage in people with Postmastectomy Lymphedema Syndrome and Pain, run by MetroHealth Medical Center at 1 site 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in self reported pain pre and post study (time frame: 2 months). 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 NCT02250898, which also lists 7 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 17 May 2018.