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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Acupuncture Point Injection; Procedure: Massage Therapy

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (trigger point injections); Patients receive standard of care trigger point injections at baseline	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Acupuncture Point Injection; Receive trigger point injections
Experimental: Arm II (myofascial release); Patients perform myofascial release for 10 minutes each day.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Massage Therapy; Perform myofascial release; Other Names: Massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Christina Le-Short, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-0498 (Other Identifier: M D Anderson Cancer Center); NCI-2020-13900 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes