Study Stopped
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Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome
A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
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Started Mar 2022
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2022
CompletedMay 17, 2022
May 1, 2022
Same day
February 3, 2021
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
through study completion, an average of 1 year
Study Arms (2)
Arm I (trigger point injections)
ACTIVE COMPARATORPatients receive standard of care trigger point injections at baseline
Arm II (myofascial release)
EXPERIMENTALPatients perform myofascial release for 10 minutes each day.
Interventions
Receive trigger point injections
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- Chronic post-mastectomy pain syndrome (\>= 3 months)
- Able to perform MFR techniques and follow basic instructions
- \>= 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Le-Short
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2021
First Posted
September 13, 2021
Study Start
March 23, 2022
Primary Completion
March 23, 2022
Study Completion
March 23, 2022
Last Updated
May 17, 2022
Record last verified: 2022-05