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

M.D. Anderson Cancer Center

Status: Withdrawn

Conditions: Breast Carcinoma

Treatments: Other: Questionnaire Administration; Procedure: Massage Therapy; Other: Quality-of-Life Assessment; Procedure: Acupuncture Point Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05041751

2020-0498 (Other Identifier)

NCI-2020-13900 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm I (trigger point injections)

Active Comparator group

Description:

Patients receive standard of care trigger point injections at baseline

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Procedure: Acupuncture Point Injection

Arm II (myofascial release)

Experimental group

Description:

Patients perform myofascial release for 10 minutes each day.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Procedure: Massage Therapy