An interventional study of Acupuncture Point Injection and Massage Therapy in Breast Carcinoma, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Patients receive standard of care trigger point injections at baseline
Procedure: Acupuncture Point Injection · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Patients perform myofascial release for 10 minutes each day.
Procedure: Massage Therapy · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Receive trigger point injections
Perform myofascial release
Also known as: Massage
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
This study is withdrawn, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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