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Myofascial Massage for Post-Mastectomy Pain and Immobility

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 2 months, 8 months, and 14 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I had breast cancer surgery between 3 to 18 months ago.
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I am female.
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I finished my breast cancer treatment within the last 18 months.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in self reported mobility scores
Change in self reported pain scores
Secondary outcome measures
Grip Strength
Pressure/Pain Threshold
Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)
+2 more

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.

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,187 Total Patients Enrolled

Media Library

Myofascial Massage Clinical Trial Eligibility Overview. Trial Name: NCT04233385 — N/A
Limited Mobility Research Study Groups: Myofascial Massage, Light Touch
Limited Mobility Clinical Trial 2023: Myofascial Massage Highlights & Side Effects. Trial Name: NCT04233385 — N/A
Myofascial Massage 2023 Treatment Timeline for Medical Study. Trial Name: NCT04233385 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation in this scientific research?

"Affirmative. According to information available on clinicaltrials.gov, this research endeavour is currently accepting participants and was initially posted in February 2020 with the last update being made in May 2022. 202 individuals are required for this experiment at a single site."

Answered by AI

What is the desired outcome of this experiment?

"This medical trial has been designed to measure a Change in self-reported mobility scores over the course of Baseline, 1 month, 2 months, 8 months and 14 months. Secondary assessments include Range of Motion (Shoulder range of motion measured by goniometer), Grip Strength (Hand grip strength evaluated via dynamometer) and Tissue Flexibility (Change in tissue flexibility observed through adherometer)."

Answered by AI

Is the opportunity still available for potential participants to join this experiment?

"Affirmative. The trial has been listed on clinicaltrials.gov since February 4th 2020 and was last modified on May 3rd 2022, signifying that it is actively recruiting patients."

Answered by AI
~0 spots leftby Apr 2024