Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

NCT04233385 | Completed

• 1 other identifier: IRB18-00912
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

About 25-50% of women who undergo breast cancer surgery develop persistent chest wall pain and shoulder mobility limitations following surgery. The pain and mobility limitations adversely affect quality of life, sleep, and body image. Unfortunately, current treatments for pain and mobility limitations have variable efficacy. Based on a review of relevant pre-, intra-, and post-operative factors, investigators reasoned that myofascial massage may address contributors to pain and mobility limitations following breast cancer surgery. Investigators propose a randomized controlled trial looking at myofascial massage compared to a light touch group to look at the effects on pain and immobility following breast cancer surgery.

Conditions

Breast Cancer; Mastectomy; Lymphedema; Pain, Shoulder; Mobility Limitation

Keywords

breast cancer; breast surgery; myofascial massage; shoulder immobility

Outcome Measures

Primary Outcomes (2)

• Change in self reported pain scores

  Shoulder Pain and Disability Index "SPADI", 5 pain items rated on a 10 point likert scale, where 0 is no pain at all and 10 is the worst pain imaginable

  Baseline, 1 month, 2 months, 8 months, and 14 months

• Change in self reported mobility scores

  Shoulder Pain and Disability Index "SPADI", 8 mobility items rated on a 10 point likert scale, where 0 means no issues with mobility and 10 means they are unable to complete the task

  Baseline, 1 month, 2 months, 8 months, and 14 months

Secondary Outcomes (5)

• Range of Motion

  Baseline, 2 months, 14 months

• Pressure/Pain Threshold

  Baseline, 2 months, 14 months

• Grip Strength

  Baseline, 2 months, 14 months

• Tissue Flexibility

  Baseline, 2 months, 14 months

• Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)

  Baseline, 2 months, 14 months

Study Arms (2)

Myofascial Massage

EXPERIMENTAL

Participants randomized to this group will receive 30 minutes of myofascial massage to their affected breast, chest, and shoulder areas twice a week for 2 months. Therapists will follow a detailed 8 week protocol developed with a massage therapy consultant and the study team.

Other: Myofascial Massage

Light Touch

ACTIVE COMPARATOR

Participants randomized to this group will receive 30 minutes of light touch to their affected breast, chest, and shoulder areas twice a week for 2 months.

Other: Light Touch

Interventions

Myofascial Massage OTHER

The myofascial protocol outlines techniques, areas of the body, as well as time to be spent for each technique for a total of 25 minutes. The remaining 5 minutes of the massage are for the massage therapist to tailor myofascial massage to the needs and circumstances of each participant. In order to provide some level of customization, the therapist will determine the impact of massage on the participant's pre-existing pain and/or mobility limitations. Second, the therapist will assess the soft tissues around the affected breast, chest, and shoulder to determine the locations of pain, tissue firmness, and restricted mobility. Third, the therapist will use effleurage and petrissage techniques to gently massage the identified locations to soften and release the tissues. Techniques used will include deep friction of muscles, sustained compression, and fascial stretch.

Myofascial Massage

Light Touch OTHER

Participants randomized to this group will receive 30 minutes of light touch to their affected breast, chest, and shoulder areas twice a week for 2 months. Therapists will follow a detailed light touch protocol for each of the 16 sessions. In addition, the therapist will inquire about the participant's response to the previous light touch treatment. Second, the therapist will assess the soft tissues around the affected breast, chest, and shoulder to determine the locations of pain, tissue firmness, and restricted mobility. Third, the therapist will place both hands on the participant for 3 minutes at each identified location. Pressure will be very light and consistent, with no side-to-side movement.

Light Touch

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is limited to females who have undergone breast cancer surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Female
• Undergone breast cancer surgery 3-18 months ago
• Completed all treatment for breast cancer within the last 18 months (i.e. radiation, IV chemotherapy, surgery)
• Not expected to have any additional surgery (i.e. planning for reconstruction)
• Self reported chronic pain or immobility since surgery

You may not qualify if:

• Under age 18
• Not female
• Surgery \< 3 months ago
• End all cancer treatments (surgery, radiation, chemotherapy) \> 18 months ago
• Presence of lymphedema
• Open wounds or sores
• Currently on anticoagulants
• Currently receiving massage treatments

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (9)

• Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

  PMID: 21435953 BACKGROUND

• Ewertz M, Jensen AB. Late effects of breast cancer treatment and potentials for rehabilitation. Acta Oncol. 2011 Feb;50(2):187-93. doi: 10.3109/0284186X.2010.533190.

  PMID: 21231780 BACKGROUND

• Hayes SC, Johansson K, Stout NL, Prosnitz R, Armer JM, Gabram S, Schmitz KH. Upper-body morbidity after breast cancer: incidence and evidence for evaluation, prevention, and management within a prospective surveillance model of care. Cancer. 2012 Apr 15;118(8 Suppl):2237-49. doi: 10.1002/cncr.27467.

  PMID: 22488698 BACKGROUND

• Hidding JT, Beurskens CH, van der Wees PJ, van Laarhoven HW, Nijhuis-van der Sanden MW. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. doi: 10.1371/journal.pone.0096748. eCollection 2014.

  PMID: 24816774 BACKGROUND

• Thomas-Maclean RL, Hack T, Kwan W, Towers A, Miedema B, Tilley A. Arm morbidity and disability after breast cancer: new directions for care. Oncol Nurs Forum. 2008 Jan;35(1):65-71. doi: 10.1188/08.ONF.65-71.

  PMID: 18192154 BACKGROUND

• Johansen S, Fossa K, Nesvold IL, Malinen E, Fossa SD. Arm and shoulder morbidity following surgery and radiotherapy for breast cancer. Acta Oncol. 2014 Apr;53(4):521-9. doi: 10.3109/0284186X.2014.880512. Epub 2014 Feb 5.

  PMID: 24495044 BACKGROUND

• Meretoja TJ, Leidenius MHK, Tasmuth T, Sipila R, Kalso E. Pain at 12 months after surgery for breast cancer. JAMA. 2014 Jan 1;311(1):90-92. doi: 10.1001/jama.2013.278795. No abstract available.

  PMID: 24381969 BACKGROUND

• Colagiuri B, Christensen S, Jensen AB, Price MA, Butow PN, Zachariae R. Prevalence and predictors of sleep difficulty in a national cohort of women with primary breast cancer three to four months postsurgery. J Pain Symptom Manage. 2011 Nov;42(5):710-20. doi: 10.1016/j.jpainsymman.2011.02.012. Epub 2011 May 26.

  PMID: 21620648 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

Breast Neoplasms; Lymphedema; Shoulder Pain; Mobility Limitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A blinded research assistant will perform all outcomes assessments of objective functional measures. Participants will be told they are being randomized into two different types of massage, however, we will not refer to they myofascial massage as "intervention" or the light touch as "active control"
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Center for Reducing Health Disparities

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: February 4, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)