Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome
Primary Purpose
Breast Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture Point Injection
Massage Therapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by

About this trial
This is an interventional treatment trial for Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Chronic post-mastectomy pain syndrome (>= 3 months)
- Able to perform MFR techniques and follow basic instructions
- >= 18 years old
Exclusion Criteria:
- Current chemotherapy
- Pending surgery during treatment
- Active infection
- Active debilitating disease
- Pregnant
- Other chronic pain diagnosis beside PMPS
- Untreated psychiatric diagnosis (not receptive to taking precautions and interventions by treating psychiatrist/psychologist/physician i.e. taking necessary medications)
- Morbid obesity (body mass index [BMI] > 40)
- Allergy history of bupivacaine and/or lidocaine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (trigger point injections)
Arm II (myofascial release)
Arm Description
Patients receive standard of care trigger point injections at baseline
Patients perform myofascial release for 10 minutes each day.
Outcomes
Primary Outcome Measures
Pain response
Defined by score differences (using the pain numerical rating scale). an 11-point scale (0-none to 10-worst) Pain responders will be defined as patients demonstrating an equal or lower pain score relative to baseline. The 2-week post-treatment assessment will be used to assess the primary endpoint.
Secondary Outcome Measures
Full Information
NCT ID
NCT05041751
First Posted
February 3, 2021
Last Updated
May 10, 2022
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05041751
Brief Title
Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome
Official Title
A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI Left Institution
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
March 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. This is known as post-mastectomy pain syndrome. Myofascial release is a form of physical therapy in which pressure is applied to the affected areas. Myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the change in pain score using the Numerical Rating Scale for pain on an 11-point scale (0-none to 10-worst) from implementation of myofascial release (MFR) versus trigger point injections (TPI) in the treatment of myofascial trigger points (MTP) as noninvasive therapies for post mastectomy pain syndrome (PMPS).
SECONDARY OBJECTIVES:
I. To evaluate the change in medications, particularly opiate medications in the treatment of post mastectomy pain.
II. To evaluate a patient's satisfaction with therapy or treatment throughout the course of the study at each consecutive encounter or follow up.
III. To evaluate a patient's range of motion with therapy or treatment beginning at time of screening and until the end of the study.
IV. To evaluate a patient's degree of lymphedema both subjectively and objectively in the affected extremity(ies) unilateral to the site(s) of mastectomy in response to the various forms of treatment throughout the study.
V. To evaluate quality of life measure changes with treatments used throughout the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care trigger point injections at baseline.
ARM II: Patients perform myofascial release for 10 minutes each day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (trigger point injections)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care trigger point injections at baseline
Arm Title
Arm II (myofascial release)
Arm Type
Experimental
Arm Description
Patients perform myofascial release for 10 minutes each day.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture Point Injection
Intervention Description
Receive trigger point injections
Intervention Type
Procedure
Intervention Name(s)
Massage Therapy
Other Intervention Name(s)
Massage
Intervention Description
Perform myofascial release
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Pain response
Description
Defined by score differences (using the pain numerical rating scale). an 11-point scale (0-none to 10-worst) Pain responders will be defined as patients demonstrating an equal or lower pain score relative to baseline. The 2-week post-treatment assessment will be used to assess the primary endpoint.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic post-mastectomy pain syndrome (>= 3 months)
Able to perform MFR techniques and follow basic instructions
>= 18 years old
Exclusion Criteria:
Current chemotherapy
Pending surgery during treatment
Active infection
Active debilitating disease
Pregnant
Other chronic pain diagnosis beside PMPS
Untreated psychiatric diagnosis (not receptive to taking precautions and interventions by treating psychiatrist/psychologist/physician i.e. taking necessary medications)
Morbid obesity (body mass index [BMI] > 40)
Allergy history of bupivacaine and/or lidocaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Le-Short
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome
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