Trigger Point Injections for Post-Mastectomy Pain Syndrome: A Double-Blind Randomized Controlled Trial With Intention-to-Treat Analysis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pressure Pain Threshold (PPT)
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients.
- •PMPS diagnosis, as per Wisotzky et col.
- •Pain > 3 months over breast, chest wall or shoulder ipsilateral to surgery.
- •Pain Visual analog Scale (VAS) ≥
- •At least one active trigger point in the following muscles: pectoralis major, superior trapezius, serratus anterior, levator scapularis, latissimus dorsi, infraspinatus
排除标准
- •Current radiation therapy or time since completion < 3months.
- •Allergy to lidocaine or other local anesthetics
- •Active infection over injection sites
- •Unavailability to be at the hospital during study intervention.
结局指标
主要结局
Pressure Pain Threshold (PPT)
时间窗: 1 month
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Visual Numeric Scale (VNS) for pain in 3 months
时间窗: 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.
Pressure Pain Threshold
时间窗: 3 months
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Trigger-points
时间窗: 3 months
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
次要结局
- Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)(3 months)
- Adverse events(3 months)
- Visual Numeric Scale (VNS) for pain in 1 month(1 month)
- Pain medication(3 months)
- Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale(3 months)
- Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)(3 months)
- Shoulder range of motion (ROM)(3 months)
- Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)(3 months)
- Neuropathic Pain Symptom Inventory (NPSI)(3 months)