INTRODUCTION: Post-Mastectomy Pain Syndrome (PMPS) refers to a condition of chronic pain persisting for more than three months after a breast surgical procedure. It affects 11 to 70% of individuals with breast cancer. The pain has a mixed etiology, often with the frequent presence of associated myofascial pain. Trigger Point Injection (TPI) is a well-established procedure in the treatment of myofascial pain in the general population. However, there are no controlled studies evaluating the efficacy of TPI in the treatment of PMPS. OBJECTIVE: To evaluate the efficacy of TPI in individuals with PMPS when combined with interdisciplinary rehabilitation and pharmacological treatment. METHODS: This is the protocol for a double-blind, placebo-controlled clinical trial. Both groups will receive routine care by a Physiatrist and Rehabilitation Team blinded to the allocation. The active group will receive Trigger Point Injections with 1% lidocaine at each identified trigger point once a week for up to three consecutive weeks. The control group will receive subcutaneous infiltrations of saline at the same points and frequency. This protocol was registered at the ClinicalTrials.gov website (NCT04267315). STATISTICAL ANALYSIS: Analysis of Covariance (ANCOVA) for between-group differences at baseline, one month, and three months for pain, central sensitization, and functionality (n=120). A significance level of alpha=5% and statistical power of 80% will be employed.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT04267315
Funding StatementThis study did not receive any funding
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present study will be available upon reasonable request to the authors
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