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Safety and tolerance in the use of Shock Wave Therapy in people with upper limb lymphedema after breast cancer treatment

Safety and tolerance of the use of Shockwave Therapy in Lymphedema secondary to the treatment of Breast Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7xpmy5
Enrollment
Unknown
Registered
2020-07-27
Start date
2020-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GATA2 Deficiency, Breast Cancer Lymphedema

Interventions

Shockwave therapy All interventions will be performed by the same physiotherapist each weekly meeting. Participants will be seen for four weeks and followed for another 30 days after the last visit (t
2. Each participant will be subjected to 4000 shock wave impulses with 0.060mJ / mm² of energy flow density, 2500 impulses in 4 distinct quadrants with a frequency of 5 Hz
3. Application of 750 impulses in the armpit and 250 impulses in the cubital region, 500 impulses in the lymphatic path from proximal to distal, 1000 impulses in fibrotic areas
4. Using a planar tip in all applications.
Other

Sponsors

Patricia Lima Ventura
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Women over 18; Women with lymphedema secondary to unilateral breast cancer surgery with an axillary approach (considered lymphedema when there is a difference in perimetry bigger or equal 2.00 cm in at least one point on the affected upper limb in relation to the contralateral one);Those who have undergone complex physical therapy (CFT) in the last year and have controlled lymphedema (with no changes in the last 30 days);Those who agree to participate in the research and sign the Informed Consent Form.

Exclusion criteria

Exclusion criteria: Those with local or remote recurrence;Women with bilateral breast cancer;Those undergoing chemotherapy or radiation therapy;Women with a postoperative period less than six months after the axillary approach; Presence of dermal changes (local signs and symptoms such as hyperemia, hyperthermia, hyperpigmentation, pustules and other skin changes); Report of autoimmune diseases (dermatomyositis, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma); Report of osteomioarticular disease in a member homolateral to the surgery; Women with amputation of a limb; Be illiterate or have difficulty reading and interpreting text;Cognitive and psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
Assess the change in skin color (redness) at the application site. Checked according to the presence of hyperemia at the place of application of Shock Wave Therapy before and after interventions. ; Assess the increase in local temperature. Checked according to the presence of hyperthermia at the application site of Shock Wave Therapy pre- and post-interventions. ; Assess the peeling of the skin at the application site. Verified with the presence of dry or wet desquamation at the site of shock wave therapy, being graded as mild, moderate and intense pre- and post-interven- tions. ; Assess the appearance of a wound at the site. Checked through the presence of continuity solution (wound) at the place of application of Shock Wave Therapy, being graded as mild, moderate and intense pre- and post-interven- tions. ; Assess the appearance of bullous lesions at the site. Verified by observing the presence of bubbles at the site of Shock Wave Therapy, being graded as mild, moderate and intense pre- and post-interventions.;Assess the degree of pain at the application site. That will be considered by the report of pain at the place of application of Shock Wave Therapy, being graded according to the Visual Analog Scale (0-10) throughout the research protocol. ; Assess the appearance of itching. That the report of itching or irritation will be observed at the place of application of Shock Wave Therapy, being graded according to the Visual Analogue Scale (0-10) throughout the research protocol. ; Assess the appearance of burning. That the report of burning in the place of application of Shock Wave Therapy will be observed, being graded according to the Visual Analogue Scale (0-10) throughout the research protocol; ;Assess discomfort at the application site. Which will be considered by the report of discomfort (discomfort) in the application sites, being graded according to the Visual Analogue Scale (0-10) throughout the research protocol. ;Assess the oc

Secondary

MeasureTime frame
Evaluate the Percentage of volume change before and after the use of OCD. Through perimetry it will be done in all segments. The patient will be seated, with the upper limbs hanging by the side of the trunk, with the chest bare. The measurement will be made at 14 and 07 cm above and 07, 14 and 21 cm below the interarticular line of the elbow. The limb volume will be estimated from the circumference measurements, treating each segment of the limb as a pair of circumferences (truncated cone). The volume of the segment will be given by: V = h (C² + Cc + c²) / (X12), where V is the volume of the segment of the member, C and c are respectively the circumferences between the points, and the distance between the circumferences (C ,ç). The sum of the difference between each point will correspond to the final estimated volume in each segment. The evaluation of the volume change between the beginning and the end, will be obtained by the formula (VI (initial volume) - VF (final volume)) / (initial volume)) * 100 that will be carried out in the initial, final and follow-up evaluations.;Evaluate the Range of motion (ROM): shoulder ROM evaluation will be carried out by a CARCI goniometer, for flexion, adduction, abduction, internal rotation and external rotation movements. The movements will be carried out actively. The patient will be positioned on the stretcher in sedation, with hips and knees flexed 90º and feet supported. To assess flexion, the upper limb will be in a neutral position and elbow extension, with the thumb up. The patient will be asked to lift the arm forward, without moving it away from the body. In assessing the extension, the arm will be positioned with 90º elbow flexion and you will be asked to take the arm back. For adduction, the patient will begin with a 90º flexion of the shoulder, with the palm down and the patient will be asked to dislodge the arm medially, without bending the elbow. For the study of abduction of the upper limb, it will be supinated an

Countries

Brazil

Contacts

Public ContactPatricia Ventura

UNIVERSIDADE FEDERAL DE SÃO PAULO

vlpatricia@hotmail.com+55-011-984073055

Outcome results

None listed

Source: REBEC (via WHO ICTRP)