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Myofascial Massage for Post-Mastectomy Pain and Immobility

N/A

Waitlist Available

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Self reported chronic pain or immobility since surgery

Must not have

Open wounds or sores

Not female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 2 months, 8 months, and 14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether myofascial massage can help with pain and immobility following breast cancer surgery.

Who is the study for?

This trial is for women over 18 who had breast cancer surgery between 3-18 months ago, are experiencing chronic pain or immobility since the operation, and have finished all treatments like radiation and chemotherapy within the last 18 months. It's not for those who ended treatment more than 18 months ago, have lymphedema, open wounds, are on anticoagulants or currently getting massages.

What is being tested?

The study compares myofascial massage to light touch therapy in women after breast cancer surgery to see which is better at reducing pain and improving shoulder mobility. Participants will be randomly assigned to one of these two approaches in a controlled setting.

What are the potential side effects?

While myofascial massage is generally safe, potential side effects may include temporary soreness or bruising at the massage site. Light touch therapy is very gentle with minimal risk of physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had chronic pain or trouble moving since my surgery.

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I am not planning to have any more surgeries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have open wounds or sores.

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I am not female.

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I have swelling due to lymph fluid buildup.

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I am currently getting massage treatments.

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I finished all cancer treatments over 18 months ago.

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I am under 18 years old.

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I am currently taking blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 2 months, 8 months, and 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 2 months, 8 months, and 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 2 months, 8 months, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in self reported mobility scores

Change in self reported pain scores

Secondary study objectives

Grip Strength

Pressure/Pain Threshold

Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Myofascial MassageExperimental Treatment1 Intervention

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.

Group II: Light TouchActive Control1 Intervention

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.

0 / 10Eligibility criteria met