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

Not Applicable

Withdrawn

• Conditions: Breast Carcinoma
• Interventions: Procedure: Massage Therapy; Procedure: Acupuncture Point Injection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05041751
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-13
• Study Start: 2022-03-23
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic post-mastectomy pain syndrome (>= 3 months)
• Able to perform MFR techniques and follow basic instructions
• >= 18 years old

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (trigger point injections)	Questionnaire Administration	Patients receive standard of care trigger point injections at baseline
Arm II (myofascial release)	Quality-of-Life Assessment	Patients perform myofascial release for 10 minutes each day.
Arm I (trigger point injections)	Quality-of-Life Assessment	Patients receive standard of care trigger point injections at baseline
Arm II (myofascial release)	Massage Therapy	Patients perform myofascial release for 10 minutes each day.
Arm II (myofascial release)	Questionnaire Administration	Patients perform myofascial release for 10 minutes each day.
Arm I (trigger point injections)	Acupuncture Point Injection	Patients receive standard of care trigger point injections at baseline

Primary Outcome Measures

Name	Time	Method
Pain response	through study completion, an average of 1 year	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.