Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome

Breast Carcinoma Clinical Trial

Official title:

A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05041751
• Other study ID #: 2020-0498
• Secondary ID: NCI-2020-1390020
• Status: Withdrawn
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: March 23, 2022

Study information

• Verified date: May 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Procedure:
• Acupuncture Point Injection
Receive trigger point injections
• Massage Therapy
Perform myofascial release

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center Website