Breast CancerNCT04233385
Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery
A study testing Myofascial Massage and Light Touch in people with Breast Cancer and Mastectomy; Lymphedema, run by MetroHealth Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Mastectomy; Lymphedema, Pain, Shoulder
- What is being tested?
- Myofascial Massage and Light Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment
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.
Read the 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.
- Being tested
- Myofascial Massage, Light Touch
- Keywords
- breast cancer, breast surgery, myofascial massage, shoulder immobility
- Medical subject headings
- Breast Neoplasms, Lymphedema, Shoulder Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial MassageOther
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 TouchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Light Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 1 month, 2 months, 8 months, and 14 months
Secondary outcomes (5)
Range of Motion
Shoulder range of motion measured by goniometer and objective functional tasks
Measured: Baseline, 2 months, 14 months
Pressure/Pain Threshold
Pressure to pain threshold as measured by algometer
Measured: Baseline, 2 months, 14 months
Grip Strength
Hand grip strength measured by dynamometer
Measured: Baseline, 2 months, 14 months
Tissue Flexibility
Change in tissue flexibility as measured by adherometer
Measured: Baseline, 2 months, 14 months
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
Measured: Baseline, 2 months, 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Feb 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ash Sehgal, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233385
- Sponsor's protocol ID
- IRB18-00912
- Status last verified
- Jun 2025
- First submitted
- 14 Jan 2020
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21435953Ewertz 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.
PubMed 21231780Hayes 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.
PubMed 22488698Hidding 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.
PubMed 24816774Thomas-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.
PubMed 18192154Johansen 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.
PubMed 24495044Meretoja 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.
PubMed 24381969Colagiuri 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.
PubMed 21620648Wallace 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.
PubMed 8880841
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment
- ClinicalTrials.gov ID
- NCT04233385
- Acronym / sponsor ID
- IRB18-00912
- Keywords
- breast cancer, breast surgery, myofascial massage, shoulder immobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Myofascial Massage | Experimental | Other: Myofascial MassageParticipants 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. |
| Light Touch | Active comparator | Other: Light TouchParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- Under age 18
- Not female
- Surgery < 3 months ago
- End all cancer treatments (surgery, radiation, chemotherapy) > 18 months ago
- Presence of lymphedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial MassageThe 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. | Other | Myofascial Massage |
| Light TouchParticipants 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. | Other | Light Touch |
Primary outcome
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
5 secondary outcomes
Range of Motion
Time frame: Baseline, 2 months, 14 months
Pressure/Pain Threshold
Time frame: Baseline, 2 months, 14 months
Grip Strength
Time frame: Baseline, 2 months, 14 months
Tissue Flexibility
Time frame: Baseline, 2 months, 14 months
Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: Baseline, 2 months, 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 21435953Andersen 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.
- Background: PubMed 21231780Ewertz 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.
- Background: PubMed 22488698Hayes 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.
- Background: PubMed 24816774Hidding 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.
- Background: PubMed 18192154Thomas-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.
- Background: PubMed 24495044Johansen 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.
- Background: PubMed 24381969Meretoja 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.
- Background: PubMed 21620648Colagiuri 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.
- Background: PubMed 8880841Wallace 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Massage and Light Touch in people with Breast Cancer and Mastectomy; Lymphedema, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self reported pain scores (time frame: Baseline, 1 month, 2 months, 8 months, and 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233385, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.