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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Mastectomy; Lymphedema Pain, Shoulder Mobility Limitation||Other: Myofascial Massage Other: Light Touch||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|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"|
|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|
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.
- 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
- 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
- Range of Motion [ Time Frame: Baseline, 2 months, 14 months ]Shoulder range of motion measured by goniometer and objective functional tasks
- Pressure/Pain Threshold [ Time Frame: Baseline, 2 months, 14 months ]Pressure to pain threshold as measured by algometer
- Grip Strength [ Time Frame: Baseline, 2 months, 14 months ]Hand grip strength measured by dynamometer
- Tissue Flexibility [ Time Frame: Baseline, 2 months, 14 months ]Change in tissue flexibility as measured by adherometer
- 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
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
|Contact: Jacqueline Dolata, MBAfirstname.lastname@example.org|