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| Name | Class |
|---|---|
| Hospital de Câncer de Barretos | OTHER |
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Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain, an specific type of muscular pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other painful conditions. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS. The intervention objective is to assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
INTRODUCTION: Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other etiologies. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS
OBJECTIVE: Assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
METHODS: Double-blind randomized controlled trial with intention-to-treat analysis. Both groups will undergo standard of care delivered by Physiatrist blinded to group allocation. Active group will undergo TPI with 1% lidocaine in each identified trigger-point, weekly, for three consecutive weeks. Control group will undergo subcutaneous saline injection superficial to the same trigger points, with the same frequency and number of sessions. Primary outcome is the mean difference between groups for pain levels, as assessed by Visual Numeric Scale (VNS), from baseline to 3 months after the procedure.
STATISTICAL ANALYSIS: Difference between groups at baseline, one and three months after injection, using Analysis of Covariance (ANCOVA) for the following outcomes: VNS; Presence of active trigger points, Pressure pain threshold (PPT); Short-Form McGill Pain Questionnaire (SF-MPQ); Neuropathic Pain Symptom Inventory (NPSI); Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); Range of motion (ROM) of affected shoulder, for abduction and external rotation; adverse events; use of pain medication.
Total sample size is 120. Alpha=5%, power=80%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | 3 weekly sessions of TPI. Participants will undergo 1mL injections of 1% lidocaine in the muscles identified with either active or latent trigger points at the initial assessment. The same muscles will be injected at all procedures. |
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| Placebo | Sham Comparator | 3 weekly sessions of subcutaneous saline injections. Participants will undergo 0.2mL subcutaneous saline injections superficial to the trigger points identified at initial assessment. The same superficial sites will be injected in all procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigger point injection | Procedure | 1mL injections of 1% lidocaine in the muscles identified active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus). |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Numeric Scale (VNS) for pain in 3 months | Mean difference of Pain between groups from baseline to 3 months(T3m), assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity. | 3 months |
| Trigger-points | Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups. | 1 month |
| Trigger-points | Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups. | 3 months |
| Pressure Pain Threshold (PPT) | Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline | 1 month |
| Pressure Pain Threshold | Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Numeric Scale (VNS) for pain in 1 month | Mean difference of Pain between groups from baseline,assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity. | 1 month |
| Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale |
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Inclusion Criteria:
Breast cancer patients.
PMPS diagnosis, as per Wisotzky et col.
Pain Visual analog Scale (VAS) ≥4.
At least one active trigger point in the following muscles: pectoralis major, superior trapezius, serratus anterior, levator scapularis, latissimus dorsi, infraspinatus
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina May Moran de Brito, MD, PhD | Instituto do Câncer do Estado de São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Câncer de Barretos | Barretos | São Paulo | Brazil | |||
| Instituto do Câncer do Estado de São Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27912994 | Background | Wisotzky E, Hanrahan N, Lione TP, Maltser S. Deconstructing Postmastectomy Syndrome: Implications for Physiatric Management. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):153-169. doi: 10.1016/j.pmr.2016.09.003. |
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Double-blind randomized controlled trial comparing the efficacy of TPI + standard of care (ACTIVE) versus sham TPI + standard of care(PLACEBO), with an intention-to-treat analysis
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Patients will be randomized as they enter the study (T0). Only one of the researchers will have access to the randomization list. The researcher responsible for the procedure will receive an email at the day of the first injection, informing of the participant's allocation group. The outcomes assessor, patient, attending Physiatrist and the Rehabilitation team will be blinded to the patient's allocation group until the end of the study. Only the researcher the performed the TPI, and the researcher responsible for the allocation list will have access to that information.
| Subcutaneous saline injection | Procedure | 0.2mL subcutaneous saline injections superficial to the muscles identified with active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus). |
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| Comprehensive Rehabilitation program | Other | Patients in both groups will undergo standard of care rehabilitation delivered by a Physiatrist, which may include Physical Therapy, Occupational Therapy, Exercise Physiologist, Rehabilitation Nurse, Psychologist, as per Physiatrist's prescription. Both the comprehensive rehabilitation program and pain medications will continue to be managed by participant's Physiatrist, who will be blinded to patient's allocation. The researchers will be responsible for TPI and for data collection. |
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Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity |
| 1 month |
| Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale | Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity | 3 months |
| Neuropathic Pain Symptom Inventory (NPSI) | Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain. | 1 month. |
| Neuropathic Pain Symptom Inventory (NPSI) | Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain. | 3 months |
| Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) | Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality. | 1 month |
| Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) | Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality. | 3 months |
| Shoulder range of motion (ROM) | Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline. | 1 month |
| Shoulder range of motion (ROM) | Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline. | 3 months |
| Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%) | Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups. | 1 month |
| Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%) | Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups. | 3 months |
| Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%) | Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups. | 1 month |
| Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%) | Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups. | 3 months |
| Adverse events | Number of participants with adverse events. Mean difference between groups. | 1 month |
| Adverse events | Number of participants with adverse events. Mean difference between groups. | 3 months |
| Pain medication | Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups. | 1 months |
| Pain medication | Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups. | 3 months |
| São Paulo |
| Brazil |
| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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