Massage for Post Breast Surgery

NCT02250898 | Completed

• 1 other identifier: IRB13-01052
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmastectomy Lymphedema Syndrome; Pain; Shoulder Mobility Impairment; Breast Surgery

Keywords

Post Breast Surgery; Myofascial Massage; Pain; Mobility Limitations

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (1)

• Change in self reported mobility pre and post study

  2 months

Study Arms (2)

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.

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.

Other: Global Relaxation Massage

Interventions

Myofascial Massage Therapy 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.

Experimental/Myofascial

Global Relaxation Massage 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

Control/Global Relaxation

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 21-79 years of age
• Female
• Breast and/or axillary surgery
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44280, United States

Location

Related Publications (7)

• 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.

  PMID: 15336336 BACKGROUND

• Drackley 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.

  PMID: 22459520 BACKGROUND

• Fernandez-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.

  PMID: 22018755 BACKGROUND

• FitzGerald 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.

  PMID: 19535099 BACKGROUND

• 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.

  PMID: 12243507 BACKGROUND

• Martin 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.

  PMID: 21392372 BACKGROUND

• Wallace 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.

  PMID: 8880841 BACKGROUND

MeSH Terms

Conditions

Pain; Mobility Limitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashwini Sehgal, MD

  Ctr for Reducing Health Disparities

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Reducing Health Disparities

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

US (1)