Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Change in self reported pain scores
研究概览
简要总结
About 25-50% of women who undergo breast cancer surgery develop persistent chest wall pain and shoulder mobility limitations following surgery. The pain and mobility limitations adversely affect quality of life, sleep, and body image. Unfortunately, current treatments for pain and mobility limitations have variable efficacy. Based on a review of relevant pre-, intra-, and post-operative factors, investigators reasoned that myofascial massage may address contributors to pain and mobility limitations following breast cancer surgery. Investigators propose a randomized controlled trial looking at myofascial massage compared to a light touch group to look at the effects on pain and immobility following breast cancer surgery.
详细描述
Myofascial massage is a deep tissue massage that focuses on muscles as well as the connective tissue that surrounds muscles, bones, and ligaments. The study team subsequently conducted a pilot randomized controlled trial involving 21 women with persistent pain and mobility limitations many months after surgery. They found that women who received myofascial massage to the affected breast/chest/shoulder had marked reductions in pain and mobility limitations and significant improvements in quality of life compared to a control group who received relaxation massage. They also established a practice-based research network of over 50 northeast Ohio massage therapists to guide future work.
The study team now proposes a full scale randomized controlled trial involving 202 women with persistent pain and mobility limitations at 2 participating sites. To help differentiate between the specific effects of myofascial massage and non-specific effects due to prolonged touch and attention from a massage therapist, the study will include an active control group that will receive light touch. Participants in each group will receive 30 minutes of treatment twice weekly for 2 months. Primary analyses will determine the impact of myofascial massage on pain and mobility limitations. Secondary analyses will examine the impact of myofascial massage on a number of secondary outcomes, including range of motion, quality of life, sleep, and body image.
Innovative features of the proposed project include a rigorous randomized controlled trial design, inclusion of an active control group, direct targeting of the affected breast/chest/shoulder, assessment of multiple mechanistic and patient-centered outcomes, and involvement of a massage practice-based research network. Investigators anticipate that the project will lead to a new and effective approach for addressing a major source of morbidity for women with breast cancer. Furthermore, the project may serve as a model for future trials of manual therapy among individuals with chronic medical conditions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
A blinded research assistant will perform all outcomes assessments of objective functional measures. Participants will be told they are being randomized into two different types of massage, however, we will not refer to they myofascial massage as "intervention" or the light touch as "active control"
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
- •18 years or older
- •Undergone breast cancer surgery 3-18 months ago
- •Completed all treatment for breast cancer within the last 18 months (i.e. radiation, IV chemotherapy, surgery)
- •Not expected to have any additional surgery (i.e. planning for reconstruction)
- •Self reported chronic pain or immobility since surgery
排除标准
- •Under age 18
- •Not female
- •Surgery < 3 months ago
- •End all cancer treatments (surgery, radiation, chemotherapy) > 18 months ago
- •Presence of lymphedema
- •Open wounds or sores
- •Currently on anticoagulants
- •Currently receiving massage treatments
结局指标
主要结局
Change in self reported pain scores
时间窗: Baseline, 1 month, 2 months, 8 months, and 14 months
Shoulder Pain and Disability Index "SPADI", 5 pain items rated on a 10 point likert scale, where 0 is no pain at all and 10 is the worst pain imaginable
Change in self reported mobility scores
时间窗: Baseline, 1 month, 2 months, 8 months, and 14 months
Shoulder Pain and Disability Index "SPADI", 8 mobility items rated on a 10 point likert scale, where 0 means no issues with mobility and 10 means they are unable to complete the task
次要结局
- Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)(Baseline, 2 months, 14 months)
- Grip Strength(Baseline, 2 months, 14 months)
- Tissue Flexibility(Baseline, 2 months, 14 months)
- Range of Motion(Baseline, 2 months, 14 months)
- Pressure/Pain Threshold(Baseline, 2 months, 14 months)
研究者
Ash Sehgal
Co-Director Center for Reducing Health Disparities
MetroHealth Medical Center