The Combined Effect of Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome After Breast Cancer Surgery With Axillary Dissection: A Comparative, Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- digital inclinometer
研究概览
简要总结
A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program.
详细描述
Patients were randomly assigned to one of three groups: Group A, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; Group B, which received only a low-energy extracorporeal shockwave treatment; and Group C, which received only the tailored exercise program. The randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. The patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick DASH scale, and diagnostic ultrasound, respectively. The randomization process was overseen by a professional physical therapist who was not involved in the study procedures.
All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.
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 well-experienced outcome assessor and participants are blind to the assignment of groups.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •between the ages of 40 and 65 years
排除标准
- •metastases of any kind
- •lymphedema,
- •a traumatic injury to the targeted upper extremity
- •a musculoskeletal disorder
- •taking any anticoagulants
- •had undergone bilateral breast cancer surgery
- •experienced locoregional recurrence
- •had vascular problems in the affected upper extremity
研究组 & 干预措施
low-energy extracorporeal shockwave and a tailored exercise program
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
干预措施: low-energy extracorporeal shockwave and a tailored exercise program (Other)
low-energy extracorporeal shockwave and a tailored exercise program
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
干预措施: low-energy extracorporeal shockwave (Other)
low-energy extracorporeal shockwave and a tailored exercise program
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
干预措施: tailored exercise program (Other)
low-energy extracorporeal shockwave
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
干预措施: low-energy extracorporeal shockwave (Other)
tailored exercise program
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises. a combination of all these types of exercises will be used. Repeat these exercises 5 times, with 3 repetitions done each day for four consecutive weeks.
干预措施: tailored exercise program (Other)
结局指标
主要结局
digital inclinometer
时间窗: 4 weeks
digital inclinometer will be used for the assessment of the shoulder range of motion. The inclinometer is placed near the shoulder at the proximal area with the patient's feet fixed, and the patients then moves their shoulder in different directions (flexion and abduction). The examiner repeats the measurements three times and takes the mean value as the proven measurement.
次要结局
- visual analogue scale(4 weeks)
- Quick DASH score(4 weeks)
- Ultrasonography(4 weeks)
研究者
Hany Mohamed Ibrahim Elgohary
associate professor
Cairo University