Breast Cancer Surgery, Transcutaneous Electric Nerve Stimulation
Conditions
Keywords
pain, lymphedema, Mastectomy, Mobility Limitation, Quality of Life
Brief summary
The aim of this randomized controlled trial was to evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on postoperative pain, lymphedema development, shoulder range of motion, and quality of life in women undergoing breast cancer surgery after neoadjuvant chemotherapy. The main questions it aims to answer are: Does TENS reduce postoperative pain? Does TENS prevent postoperative lymphedema? Does TENS increase postoperative shoulder range of motion? Does TENS improve postoperative quality of life? The researchers will compare the effects of TENS after breast surgery with a control group. Participants will be assessed for pain, lymphedema development, and shoulder range of motion before surgery, on the first day after surgery, at the first month after surgery, and at the third month after surgery. Quality of life will be assessed before surgery, at the first month after surgery, and at the third month after surgery.
Interventions
DEVICETENS
After the surgery, 2 TENS electrodes will be placed on the inner part of the upper arm of the patient's arm on the side where surgery was performed, and the frequency will be 100 Hz, the pulse duration will be 100 µs and the amplitude will be adjusted so as not to cause muscle contraction, and a 20-minute TENS application will be performed.
Sponsors
The Scientific and Technological Research Council of Turkey
Seda Akutay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Intervention model description
TENS group and control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Those whose primary cancer tissue is breast * ASA classification is between I and III * Having unilateral breast surgery
Exclusion criteria
* Those with cardiac problems and those using a pacemaker * Pregnant * Cognitively impaired * Disruption of skin integrity in the TENS application area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Until the end of 3 month | The Visual Analog Scale (VAS) scale will be used to assess pain intensity. It is a 10 cm line with connecting expressions on the left (no pain) and on the right (extreme pain). The patient is asked to mark the current pain level on the line. It means that the pain intensity increases as you move from left to right. |
| Lymphedema severity | Until the end of 3 month | A tape measure will be used to assess the severity of lymphedema. Measurements will be made bilaterally at 6 different points (Hand circumference, wrist, 15 cm below the elbow, 7,5 cm below the elbow, 7,5 cm above the elbow, 15 cm above the elbow )on the arm. |
| Shoulder and arm mobility | Until the end of 3 month | Shoulder range of motion (flexion, extension, abduction, internal rotation and external rotation angles of the arm) was measured with a goniometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity functions | Preoperative period, postoperative 1 month and postoperative 3 month | The Quick Disability of the Arm, Shoulder and Hand (QuickDASH) Questionnaire and hand dynamometer will be used. In QuickDASH, a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. |
| Cancer Related Quality of Life | Preoperative period, postoperative 1 month and postoperative 3 month | European Organization for Cancer Research and Treatment Quality of Life Questionnaire-30- EORTC QLQ-C30 will be used. |
Countries
Turkey (Türkiye)
Outcome results
None listed