Effect of Yoga Therapy in Management of Post-operative Myofascial Pain in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Intensity of Pain by neumarical rating scale (NRS)
研究概览
简要总结
Pain after breastcancer surgery is a major problem and women undergoing mastectomy and breastreconstruction experience postoperative pain syndromes in approximatelyone-half of all cases.The cause of pain following breast cancersurgery can be as a result of extensive tissue damage, brachial plexus injuryfollowing axillary dissection, vascular injury, infection, axillary websyndrome, lymphedema, etc. Yogainterventions have demonstrated positive effects on behavioral symptoms relatedto fatigue, including depressed mood, pain and physical function..Variouscomponents of yoga program such as asanas, meditation, pranayama and relaxationhave been used in these studies. Yoga has also demonstrated its utility inother chronic pain syndromes such as fibromyalgia in non-cancer populations. The aim of this study is to evaluate the effect of Yoga Therapy in Managementof Post-operative Myofascial Pain in Breast Cancer Patients.Each patient who is eligible to take part will be randomly allocated to Test or control group. Both groups will receive standard care in the form of surgery, chemotherapy, radiotherapy and physiotherapy as adviced by the oncologist. Yoga group will undergo 35 min Yoga protocol along with standard care for 4 weeks. Both groups will be assessed after 4 weeks to see the improvements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients Diagnosed with any myofascial pain syndrome Those with a history of breast conservation or simple mastectomy within last six months.
- •First time primary diagnosis of breast cancer (grades I to IIIA), Neck and shoulder/axillary pain that began after the breast cancer surgery.
- •Asymmetric shoulder pain (NRS on painful side : NRS on non painful side > 2:1) Acute or Chronic myofascial pain syndrome with severe intensity i.e NRS > 4/
- •Patients with pain at least 4 days in a week.
- •Patients without neurological pain, as in DN4 score less than
- •Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study.
- •Patients who read, understood and signed the Free and Clarified Consent Term.
排除标准
- •Other medical conditions (i.e, arthritis) like periarthritis of shoulder joint,frozen shoulder, cervical disc herniation etc.
- •Recurrent cancer Previous diagnosis of fibromyalgia syndrome.
- •Patients with major depression, according to DSM-IV criteria.
- •Intermittent pain history.
- •Patients with another pain syndrome in shoulders.
- •Patients who had contraindications (for example, symptoms consistent with severe disk disease) or autoimmune disorders.
结局指标
主要结局
1. Intensity of Pain by neumarical rating scale (NRS)
时间窗: Baseline on Day 1, 1 week, on the day of suture removal, after 4 weeks
2. Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline on Day 1, 1 week, on the day of suture removal, after 4 weeks
3. Pressure Pain threshold by algometer
时间窗: Baseline on Day 1, 1 week, on the day of suture removal, after 4 weeks
次要结局
- 1. Resting Heart rate variability (HRV):(2.National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NCCN-FACT FBSI-16) Questionnaire)