Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome

NCT05115799 | Recruiting

• 1 other identifier: AWS
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Mastectomy; Lymphedema; Thrombi; Thrombosis; Shoulder Syndrome; Movement Disorders

Keywords

mastectomy; breast cancer; lymphedema; kinesiology applied; thrombosis; health education; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Shoulder Functionality tested with DASH Scale

  3 Months

• Shoulder Pain. Visual Analogic Scale (VAS)

  3 Months

• Shoulder Functionality tested with Constant Scale

  3 Months

Study Arms (2)

Patients with Axilliary Web Syndrome and manual therapy and scar massage.

EXPERIMENTAL

These users will come from the first moment of the diagnosis of the thrombus in our unit, to receive manual therapy by the physical therapist. They will receive 15 sessions of manual therapy by the physiotherapist, 5 days a week, each session being approximately 40 minutes long. The session will begin with pendulum exercises of the shoulder to warm up the joint and give proprioceptive stimulation to the joint capsule. The physiotherapist will perform passive stretches looking to put tension on the cord lymphatic, never exceeding grade 6 VAS pain. Mainly the shoulder will be worked affected, and if the cord reaches the crease of the elbow or thumb, the extension-supination of the elbow, and ulnar deviation of the wrist. Scar massage will be done in the area where the lymphatic cord originates at the proximal level while maintaining the tolerable tension of the lymphatic cord (during the massage also pain grade 6 VAS will be exceeded).

Other: Manual Therapy, Physiotherapy, Kinesiology, Scar Massage

Patients with Axilliary Web Syndrome and health education and kinesiotherapy.

OTHER

These users will be instructed in hygienic-postural care and active auto-kinesitherapy assisted to perform daily for 30 minutes. The investigators will value following the instructions every 30 days

Other: Kinesiotherapy, Physiotherapy, Health Education

Interventions

Manual Therapy, Physiotherapy, Kinesiology, Scar Massage OTHER

The physiotherapist performs passive kinesitherapy on the mastectomized patient with lymphatic thrombus, and scar massage when the arm maintains its greater range of mobility. The patient will never present pain during the rehabilitation session above 5 in Pain Scale Analog Scale.

Patients with Axilliary Web Syndrome and manual therapy and scar massage.

Kinesiotherapy, Physiotherapy, Health Education OTHER

These users will be instructed in hygienic-postural care and active auto-kinesitherapy assisted to perform daily for 30 minutes. The investigators will value following the instructions every 30 days

Patients with Axilliary Web Syndrome and health education and kinesiotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Jesús Baltasar González Rubiño

Algeciras, Cádiz, 11201, Spain

RECRUITING

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Related Links

• Pain Visual Analogic Score
• Constant Score Test for Shoulder
• Calculation of the sample size

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Thrombosis; Movement Disorders; Health Education

Interventions

Musculoskeletal Manipulations; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Officials

• Rocío Martín Valero, Physiothera

  Malaga U

  STUDY DIRECTOR

• María Jesús Viñolo Gil, Physiothera

  Cádiz U

  STUDY DIRECTOR

Central Study Contacts

Jesus G Physiotherapist, Physiothera

CONTACT

651452494; jesusbaltasar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 10, 2021
• Study Start: December 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 4, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: In two years. In October 2023.
• Access Criteria: Open file

Locations

ES (1)