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Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT04233385
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Ash Sehgal, MetroHealth Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Mastectomy; Lymphedema Pain, Shoulder Mobility Limitation Other: Myofascial Massage Other: Light Touch Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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"
Primary Purpose: Treatment
Official Title: Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Myofascial Massage
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
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.

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Change in self reported pain scores [ Time Frame: Baseline, 1 month, 2 months, 8 months, and 14 months ]
    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

  2. Change in self reported mobility scores [ Time Frame: Baseline, 1 month, 2 months, 8 months, and 14 months ]
    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


Secondary Outcome Measures :
  1. Range of Motion [ Time Frame: Baseline, 2 months, 14 months ]
    Shoulder range of motion measured by goniometer and objective functional tasks

  2. Pressure/Pain Threshold [ Time Frame: Baseline, 2 months, 14 months ]
    Pressure to pain threshold as measured by algometer

  3. Grip Strength [ Time Frame: Baseline, 2 months, 14 months ]
    Hand grip strength measured by dynamometer

  4. Tissue Flexibility [ Time Frame: Baseline, 2 months, 14 months ]
    Change in tissue flexibility as measured by adherometer

  5. Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B) [ Time Frame: Baseline, 2 months, 14 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is limited to females who have undergone breast cancer surgery.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233385


Contacts
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Contact: Jacqueline Dolata, MBA 2167781792 jdolata@metrohealth.org

Locations
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United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Jacqueline Dolata, MBA    216-778-1792    jdolata@metrohealth.org   
Contact: Mary Jo Day, LPN    216-778-8456    mday@metrohealth.org   
Sponsors and Collaborators
MetroHealth Medical Center
Publications:

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Responsible Party: Ash Sehgal, Co-Director Center for Reducing Health Disparities, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT04233385    
Other Study ID Numbers: IRB18-00912
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ash Sehgal, MetroHealth Medical Center:
breast cancer
breast surgery
myofascial massage
shoulder immobility
Additional relevant MeSH terms:
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Breast Neoplasms
Shoulder Pain
Lymphedema
Mobility Limitation
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations