Massage for Post Breast Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

NCT04233385

Breast Cancer Mastectomy; Lymphedema Pain, Shoulder +1 more

COMPLETED NA

The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Tissue Reconstruction

NCT01736605

Breast Cancer

COMPLETED NA

Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms

NCT00058851

Lymphedema

COMPLETED PHASE2

Preoperative Massage in Breast Surgery Patients

NCT01667328

Anxiety Presurgical Anxiety Breast Cancer

COMPLETED NA

Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery

NCT06297265

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Localized Breast Carcinoma

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmastectomy Lymphedema Syndrome Pain Shoulder Mobility Impairment Breast Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental/Myofascial

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.

Group Type EXPERIMENTAL

Myofascial Massage Therapy

Intervention Type OTHER

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.

Control/Global Relaxation

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.

Group Type ACTIVE_COMPARATOR

Global Relaxation Massage

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Myofascial Massage Therapy

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.

Intervention Type OTHER

Global Relaxation Massage

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes