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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Withdrawn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
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    February 3, 2021
    Last Updated
    May 10, 2022
    Sponsor
    M.D. Anderson Cancer Center
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    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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