Clinical trial NCT05115799: Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome
Official title: Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Mastectomy; Lymphedema
Thrombi
Thrombosis
Shoulder Syndrome
Movement Disorders
Keywords: mastectomy
breast cancer
lymphedema
kinesiology applied
thrombosis
health education
rehabilitation
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

Postmastectomy lymphedema is one of the best-known postsurgical and post-actinic sequelae after breast cancer, with a prevalence of around 20% of mastectomized women.

The conservative treatment of this health problem is based on Decongestive Physical Therapy and Kinesitherapy. Pneumatic Multicompartmental Pressotherapy helps reduce the feeling of heaviness and stiffness of edema.

In addition to postmastectomy lymphedema, the patient undergoing surgery for breast cancer may present Axillary Web Syndrome (AWS) or superficial lymphatic thrombosis. As described by W.M. Yeung et al. In their systematic review, it can appear in the first eight weeks after the operation and usually resolves spontaneously within three months of its appearance.

The lymphatic thrombus is clinically manifested as a cord that frequently occurs in the armpit, although it can also appear along the upper limb, elbow crease even reaching the first finger. Regarding the diagnosis through imaging tests, nuclear magnetic resonance does not manage to clearly identify the axillary network syndrome, being ultrasound the most reliable method, due to the dynamism that can be applied to the patient's arm while the diagnostic test is being carried out.

The axillary network syndrome produces pain when abducting and flexing the shoulder, with the respective loss of functionality and limitation of mobility of the affected upper limb.

According to the American Cancer Society, radiation therapy is applied 3-8 weeks after the operation if chemotherapy is not required. If chemotherapy is used, it is applied 3-4 weeks after completion. It is usually applied 5 days a week from Monday to Friday.

The limitation of mobility often leads to a delay in the application of this useful tool in the oncological therapeutic arsenal to prevent recurrences. Hence, the need and importance of this study, where the investigator intend to demonstrate that the evolution times of the lymphatic thrombus can be reduced with assisted passive kinesitherapy and stretching.

At present, there are some publications that show possible alternatives of physiotherapy treatment for lymphatic thromb. Many are interventions with a very small sample (even on a caseby-case basis). Others are observational studies or even studies older than five years. There are some studies that combine manual lymphatic drainage (Vodder method) with physical therapy (strengthening, stretching, soft tissue work) with good results.

There is ambiguity in the relationship-association between the appearance of lymphatic thrombosis and lymphedema of the ipsilateral limb. Patients who have developed AWS are 44% more likely to develop postmastectomy lymphedema. There are other studies that do not find a relationship between the two.

The frequency of the AWS is not clear from the current posts. It depends on the type of surgical intervention, age, BMI, the appearance of the postoperative seroma, and even breast reconstruction. Thus being the frequency 30% of the operated patients.

After reviewing the relevant literature, it should be noted that there are very few studies and therefore little evidence on the treatment of AWS. It is not possible to prescript of a clear treatment in a clinical practice guide for this postsurgical sequela. Most publications highlight the importance and need for more research to determine the etiopathogenesis and useful treatment for this health issue.

OBJECTIVES GENERAL OBJECTIVES

I. Determine a preliminary exploration of the magnitude of the effect of a kinesitherapy and stretching intervention for the functional recovery of the upper limb, the recovery of the surgical scar and the improvement of the quality of life in women who have suffered from breast cancer. II. Create a scale to objectively classify the axillary thrombus (based on its clinical manifestations).

SPECIFIC OBJECTIVES for general objective I:

* Check the intervention of assisted passive kinesitherapy and stretching for the improvement of the range of joint mobility of the affected limb in the shortest possible time. - Analyze the reduction of pain and increase of the degree of functionality of the ipsilateral upper limb in patients with AWS after the intervention.
* Determine the impact of the physiotherapeutic intervention on the quality of life of a mastectomized woman with lymphatic thrombus.
* Analyse the physiotherapeutic intervention reduction of the time on the evolution of the Superficial Lymphatic Thrombus and the application of Radiotherapy within the terms established in the oncological protocols.

SPECIFIC OBJECTIVES for general objective II:

- Create a scale to objectively classify the axillary thrombus (based on its clinical manifestations).

METHODOLOGY TYPE OF STUDY

Quasi-experimental, prospective study.

STUDY POPULATION

The study sample is made up of patients undergoing surgery for Breast Cancer who attend the Lymphedema Unit of the A.G.S. Campo de Gibraltar Oeste presenting Lymphatic Thrombus after the operation, the recruitment period being from December 2021 to December 2023.

DESCRIPTION OF THE INTERVENTION

15 sessions of Assisted Passive Kinesitherapy are carried out by the physiotherapist. Five days a week, for three weeks. If it is previously referred, the treatment will be finished earlier (the patient must achieve the same ranges of motion and strength as the contralateral limb, together with the remission of pain).

The stretches applied during the sessions will be gentle and maintained, never exceeding a pain grade 5 VAS (moderate pain), once the tension of the cord is reached between 20-30 seconds. A special effort will be made to recover flexion and abduction of the shoulder, bringing the cord to a tolerable tension on the part of the patient.

Friction will be made on the axillary scar to dislodge underlying planes and the subcutaneous tissue of the muscle fascia.

The patient will be trained in active kinesitherapy to prevent lymphedema and activate lymphatic circulation. Also with hygienic-postural measures for the same purpose.

CONTROL GROUP

All the variables and data for each patients are recorded in their clinical history. Goniometric study will be performed of the affected upper limb (shoulder, elbow, wrist). Constant scale, Quick-Dash, the Visual Analog Pain Scale and the International Scale of Physical Activity will also be performed. This assessment will be carried out the patient arrives at our unit and on day 30, 60, 90.

These patients will be instructed in hygienic-postural care and active assisted autokinesitherapy to perform daily for 30 minutes. It will be assessed every 30 days.

These exercises are explained to the patient to be executed at home.

INTERVENTION GROUP

As well as the control group, all the variables and data for each patient will be collected in their medical history. Goniometric study of the affected upper limb will be performed too (shouderelbow-wrist). Constan scale, Quick- DASH, Visual Scale will also be completed together with Analogue of Pain and the International Scale of Physical Activity. This exploration will also take place during the first session and on the 30th, 60th and 90th day.

These users will arrive at the first diagnosis of the thrombus in our unit,in order to receive manual therapy by the physical therapist. (see therapy pictures).

They will receive 15 sessions of manual therapy 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 tensioning the lymphatic cord, never exceeding grade 6 VAS pain chart. Mainly the affected shoulder will be treated and if the cord reaches the crease of the elbow or thumb, the extension (frase sin sentido general hay que volverla a escribir).

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 6VAS will be exceeded).

Patients with developed lymphedema will receive Decongestive Physical Therapy (PDT) on the treated limb once the 15 day treatment described for the study is finished. Therefore, PDT does not influence on obtained contaminated results. Those patients who do not suffer from lymphedema do not receive PDT.

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder Range of Movement (ROM) in the limb with Axillary Web Syndrome
timeFrame: 3 Months
measure: Quality of life. Barthel Scale
timeFrame: 3 Months
Secondary outcomes:
measure: Shoulder Functionality tested with DASH Scale
timeFrame: 3 Months
measure: Shoulder Pain. Visual Analogic Scale (VAS)
timeFrame: 3 Months
measure: Shoulder Functionality tested with Constant Scale
timeFrame: 3 Months
Other outcomes:
Locations:
city: Algeciras
country: Spain
facility: Jesús Baltasar González Rubiño
state: Cádiz
Study officials:
affiliation: Malaga U
name: Rocío Martín Valero, Physiothera
role: STUDY_DIRECTOR
affiliation: Cádiz U
name: María Jesús Viñolo Gil, Physiothera
role: STUDY_DIRECTOR
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