A Pilot Study Assessing the Benefits of Fascial Freedom for the Win (MFR Versus TPI)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pain response
研究概览
简要总结
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.
详细描述
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.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chronic post-mastectomy pain syndrome (>= 3 months)
- •Able to perform MFR techniques and follow basic instructions
- •>= 18 years old
排除标准
- •Current chemotherapy
- •Pending surgery during treatment
- •Active infection
- •Active debilitating disease
- •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
结局指标
主要结局
Pain response
时间窗: 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.
次要结局
未报告次要终点