Skip to main content
OpenTrials
Completed

NCT Number: NCT04233385

Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Arthralgia Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Joint Diseases Lymphatic Diseases Lymphedema Mastectomy; Lymphedema Mobility Limitation Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Shoulder Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2020
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.