Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233385
• Other study ID #: IRB18-00912
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: MetroHealth Medical Center
• Contact: Jacqueline Dolata, MBA
• Phone: 2167781792
• Email: jdolata[@]metrohealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Myofascial massage is a deep tissue massage that focuses on muscles as well as the connective tissue that surrounds muscles, bones, and ligaments. The study team subsequently conducted a pilot randomized controlled trial involving 21 women with persistent pain and mobility limitations many months after surgery. They found that women who received myofascial massage to the affected breast/chest/shoulder had marked reductions in pain and mobility limitations and significant improvements in quality of life compared to a control group who received relaxation massage. They also established a practice-based research network of over 50 northeast Ohio massage therapists to guide future work.

The study team now proposes a full scale randomized controlled trial involving 202 women with persistent pain and mobility limitations at 2 participating sites. To help differentiate between the specific effects of myofascial massage and non-specific effects due to prolonged touch and attention from a massage therapist, the study will include an active control group that will receive light touch. Participants in each group will receive 30 minutes of treatment twice weekly for 2 months. Primary analyses will determine the impact of myofascial massage on pain and mobility limitations. Secondary analyses will examine the impact of myofascial massage on a number of secondary outcomes, including range of motion, quality of life, sleep, and body image.

Innovative features of the proposed project include a rigorous randomized controlled trial design, inclusion of an active control group, direct targeting of the affected breast/chest/shoulder, assessment of multiple mechanistic and patient-centered outcomes, and involvement of a massage practice-based research network. Investigators anticipate that the project will lead to a new and effective approach for addressing a major source of morbidity for women with breast cancer. Furthermore, the project may serve as a model for future trials of manual therapy among individuals with chronic medical conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Other:
• Myofascial Massage
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.
• Light Touch
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.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2017 Apr 25;317(16):1693. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Range of Motion	Shoulder range of motion measured by goniometer and objective functional tasks	Baseline, 2 months, 14 months
Secondary	Pressure/Pain Threshold	Pressure to pain threshold as measured by algometer	Baseline, 2 months, 14 months
Secondary	Grip Strength	Hand grip strength measured by dynamometer	Baseline, 2 months, 14 months
Secondary	Tissue Flexibility	Change in tissue flexibility as measured by adherometer	Baseline, 2 months, 14 months
Secondary	Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)	44-item questionnaire designed to measure physical well-being, social/family well-being, emotional well-being, functional well-being, and additional breast cancer-specific concerns	Baseline, 2 months, 14 months