Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Malaga
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Shoulder Range of Movement (ROM) in the limb with Axillary Web Syndrome
Study Overview
Brief Summary
ABSTRACT
Breast cancer is the most common malignant tumor in women, with more than a million new cases annually. One of the most frequent surgical and post-actinic sequelae and well known is postmastectomy lymphedema. The axillary web syndrome is another sequel that limits the functionality of the patient and delays the protocol times of application of treatments cancer, and in many cases this sequela is misdiagnosed. This surgical sequelusually disappears spontaneously after the third month of appearance, but this implies a long period of discomfort and limitations for the user, at the same time that it may delay the application of Radiotherapy within the indicated protocol deadlines (due to the need for a body posture with abduction and flexion of the affected upper limb for its application and with the lymphatic thrombus is impossible to get).
With the present quasi-experimental study, the investigator intend to show that the application of Kinesitherapy and stretching from the beginning of the appearance of the cord, in a controlled and scheduled way by the physiotherapist, it is possible to reduce the time in which the lymphatic thrombus is present, and therefore, recover functionality, mobility, reduce pain and be able to apply the patients´ treatments within of the established deadlines. The investigator intend to apply this therapy in the intervention group and compare thrombus evolution times with the control group.
Detailed Description
BACKGROUND AND CURRENT STATUS OF THE STUDY TOPIC
Breast Cancer is the most common tumor in women around the world, and is one of the leading causes of death among women in developed countries.
It is an important Public Health problem, since according to the World Health Organization more than a million new cases are diagnosed annually, becoming almost a quarter of malignant tumors in females. In the West, it has been shown that one in nine to twelve women will suffer from the disease in her lifetime.
Most cases occur in postmenopausal women, and the main age at diagnosis is around 60 years.
After the diagnosis of breast cancer, the patient undergoes surgical and / or cancer treatment. Chemotherapy, radiotherapy and hormonal therapy are some of the treatment alternatives, which currently are precisely adapted to the type of tumor seeking a better response and survival.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The randomization of the sample is done through the Excel program, where the "randomization" function distributes the numbers from 1 to 46 (number of research members) in the control group or intervention group.
As patients with this health problem arrive, they are distributed in order of arrival in both groups as determined by randomization
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient over 18 years old.
- •Mastectomized patients (either radical or conservative surgery).
- •Patient with lymphatic thrombus in the upper limb ipsilateral to the surgical intervention.
Exclusion Criteria
- •Significant psychological alterations that would prevent the retrieval of the information necessary for the investigation.
- •Significant neurological alterations that would prevent the retrieval of the information necessary for the investigation.
- •Patients in a situation of legal dispute that would affect their intervention in this study.
- •Metastasis not treated with chemotherapy treatment.
Outcomes
Primary Outcomes
Shoulder Range of Movement (ROM) in the limb with Axillary Web Syndrome
Time Frame: 3 Months
The investigators will use Goniometry of both shoulders. It is a continuous quantitative variable. Goniometer is the standard instrument for measuring the range of movement. The patients were asked to move thir arms in flexion, extension, abduction and external and internal rotation of the shoulder. It was considered that the maximum range of motion for the flexion and abduction was 180º, for extension it was 45º, 100º for internal rotation and 80º for external rotation. Finally, a single index was calculated as the percentage of global movement ().
Quality of life. Barthel Scale
Time Frame: 3 Months
The investigators will use the Barthel Scale. The Barthel index or Barthel scale is an instrument used by social and health professionals for the functional assessment of a patient and to monitor their evolution. In the case of Social Workers, they value the independence or dependence of the person in each of the activities of daily living (ADL), obtaining as a result the level of performance of the person and carrying out a rehabilitative / compensatory intervention and / or maintenance according to the results obtained. Promoting and / or maintaining the independence of the person. The scale measures the ability of a person to perform 10 activities of daily life, which are considered basic, in this way a quantitative estimate of their degree of independence is obtained. 100 points is the highest score and the best result in the patient's functionality. 0 points is the worst result and shows the worst functional status.
Secondary Outcomes
- Shoulder Functionality tested with DASH Scale(3 Months)
- Shoulder Pain. Visual Analogic Scale (VAS)(3 Months)
- Shoulder Functionality tested with Constant Scale(3 Months)
Investigators
Jesús Baltasar
Principal Investigator
University of Malaga