UnknownNot Applicable

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

Spain46 participantsStarted 2021-12-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Shoulder Range of Movement (ROM) in the limb with Axillary Web Syndrome

Timeframe: 3 Months

Quality of life. Barthel Scale

Timeframe: 3 Months

Trial details

NCT IDNCT05115799

SponsorUniversity of Malaga

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

Contact for this trial

Jesus G Physiotherapist, Physiothera

651452494 jesusbaltasar@gmail.com

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