Breast Cancer SurgeryNCT06973265
Effects of Transcutaneous Electrical Nerve Stimulation on Breast Surgery
A study testing TENS in people with Breast Cancer Surgery and Transcutaneous Electric Nerve Stimulation, run by Seda Akutay at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Surgery, Transcutaneous Electric Nerve Stimulation
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those whose primary cancer tissue is breast
- ASA classification is between I and III
- Having unilateral breast surgery
Who cannot join
- Those with cardiac problems and those using a pacemaker
- Pregnant
- Cognitively impaired
- Disruption of skin integrity in the TENS application area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Lymphedema, Upper Extremity Functions, and Quality of Life in Patients Undergoing Breast Surgery After Neoadjuvant Chemotherapy
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.
- Being tested
- TENS
- Keywords
- pain, lymphedema, Mastectomy, Mobility Limitation, Quality of Life
- Medical subject headings
- Pain, Lymphedema, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | Patients in this group will receive TENS treatment for 1 month after surgery. Receives: Device: TENS |
| Control group | No intervention | Patients in this group do not receive TENS application after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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.
Measured: Until the end of 3 month
Lymphedema severity
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.
Measured: Until the end of 3 month
Shoulder and arm mobility
Shoulder range of motion (flexion, extension, abduction, internal rotation and external rotation angles of the arm) was measured with a goniometer.
Measured: Until the end of 3 month
Secondary outcomes (2)
Upper extremity functions
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.
Measured: Preoperative period, postoperative 1 month and postoperative 3 month
Cancer Related Quality of Life
European Organization for Cancer Research and Treatment Quality of Life Questionnaire-30- EORTC QLQ-C30 will be used.
Measured: Preoperative period, postoperative 1 month and postoperative 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Sep 2024
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TENS group and control group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seda Akutay
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Seda Akutay, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973265
- Sponsor's protocol ID
- EUniversity
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akutay S, Yuceler Kacmaz H, Ceyhan O. The healing power of transcutaneous electrical nerve stimulation: a systematic review on its effects after breast surgery. Support Care Cancer. 2025 Jan 13;33(2):90. doi: 10.1007/s00520-024-09129-3.
PubMed 39804405
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Lymphedema, Upper Extremity Functions, and Quality of Life in Patients Undergoing Breast Surgery After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06973265
- Acronym / sponsor ID
- EUniversity
- Keywords
- pain, lymphedema, Mastectomy, Mobility Limitation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seda AkutayUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- TENS group and control group
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: TENSPatients in this group will receive TENS treatment for 1 month after surgery. |
| Control group | No intervention | –Patients in this group do not receive TENS application after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those whose primary cancer tissue is breast
- ASA classification is between I and III
- Having unilateral breast surgery
Key exclusion criteria (4 listed)
- Those with cardiac problems and those using a pacemaker
- Pregnant
- Cognitively impaired
- Disruption of skin integrity in the TENS application area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSAfter 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. | Device | TENS group |
Primary outcome
Pain intensity
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Upper extremity functions
Time frame: Preoperative period, postoperative 1 month and postoperative 3 month
Cancer Related Quality of Life
Time frame: Preoperative period, postoperative 1 month and postoperative 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 39804405Akutay S, Yuceler Kacmaz H, Ceyhan O. The healing power of transcutaneous electrical nerve stimulation: a systematic review on its effects after breast surgery. Support Care Cancer. 2025 Jan 13;33(2):90. doi: 10.1007/s00520-024-09129-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Breast Cancer Surgery and Transcutaneous Electric Nerve Stimulation, run by Seda Akutay at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Until the end of 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.