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

NCT ID: NCT05041751

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2022-03-23

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (trigger point injections)

Patients receive standard of care trigger point injections at baseline

Group Type: ACTIVE_COMPARATOR

Acupuncture Point Injection

Intervention Type: PROCEDURE

Receive trigger point injections

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (myofascial release)

Patients perform myofascial release for 10 minutes each day.

Group Type: EXPERIMENTAL

Massage Therapy

Intervention Type: PROCEDURE

Perform myofascial release

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Acupuncture Point Injection

Receive trigger point injections

Intervention Type: PROCEDURE

Massage Therapy

Perform myofascial release

Intervention Type: PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Massage; Quality of Life Assessment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Le-Short

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2020-13900

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0498

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0498

Identifier Type: -

Identifier Source: org_study_id