Breast Cancer Clinical Trial
Official title:
Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome
NCT number | NCT05115799 |
Other study ID # | AWS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2021 |
Est. completion date | December 4, 2024 |
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | December 4, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Jesús Baltasar González Rubiño | Algeciras | Cádiz |
Lead Sponsor | Collaborator |
---|---|
University of Malaga |
Spain,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder Range of Movement (ROM) in the limb with Axillary Web Syndrome | 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 (). | 3 Months | |
Primary | Quality of life. Barthel Scale | 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. |
3 Months | |
Secondary | Shoulder Functionality tested with DASH Scale | The investigators will use the DASH Scale.
The Disabilities of the Hand, Arm and Shoulder (DASH) questionnaire is a specific instrument for measuring the quality of life related to health problems to the upper limbs. It is validated in Spanish and it consists of 30 questions. The final score calculation is relatively complicated. In order to calculate the scores it is necessary to have answered at least 27 out of the 30 questions. The final scores is obtained by calculating the arithmetic means of the questions answered minus 1 times 25. The DASH questionnaire has excellent reproductibility and high sensitivity, being able to detect small changes. The scale ranges from 30 to 150 points. 30 points means good shoulder functionality and 150 non-functional shoulder. It has two optional subsections where sports and work functionality can be assessed. |
3 Months | |
Secondary | Shoulder Pain. Visual Analogic Scale (VAS) | The investigators will use the Visual Analog Pain Scale.
According to the National Cancer Institue ( NIH), it is a tool used to help the professional assess the intensity of certain sensations and feelings, such as pain. The Visual Analog Scale for pain is composed of a straight line on which an extreme means no pain and the other extreme means the worst pain imaginable. Extreme pain corresponds to 10 points. None pain corresponds to 0 points. The patient marks a point on the line that matches the amount of pain they feel. Also known as VAS. |
3 Months | |
Secondary | Shoulder Functionality tested with Constant Scale | The investigators wil use the Constant Scale. Constant Scale: According to the Spanish Society for Shoulder and Elbow Surgery (SECHC), the Constant Scale assesses pain, functionality for daily life activities, joint mobility and shoulder strength. Also, it considers the laterality and the time it takes the patient. The score ranges from 0 points to 100 points, being 100 the optimal condition for the shoulder. | 3 Months |
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