Quality of LifeNCT06069908
Transcutaneous Auricular Vagus Nerve Stimulation in Upper Extremity Lymphedema
A study testing Complex Decongestive Treatment, Transcutaneous Auricular Vagus Nerve Stimulation and Exercise in people with Quality of Life and Lymphedema, run by Seda Saka at 2 sites in Turkey (Türkiye).
Trial summary
Lymphedema is an inflammatory disease characterized by abnormal accumulation of excess water, plasma proteins, and extravascular blood and parenchymal cells in the affected upper and lower arms, chest and/or trunk due to inadequate lymphatic transport capacity, and is associated with high-severity, recurrent soft… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life, Lymphedema, Hand Grasp
- What is being tested?
- Complex Decongestive Treatment, Transcutaneous Auricular Vagus Nerve Stimulation and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Sep 2023to 11 Dec 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65
- Diagnosed with secondary lymphedema disease by the physician
- Minimum of three months after surgery
- Stage 2 and 3 patients
- Native speaker Turkish
- Individuals who agreed to participate in the study
Who cannot join
- Individuals with any neurological or orthopedic problems in the upper extremity
- Individuals undergoing upper extremity surgery
- Presence of cardiac edema
- Presence of arterial disease
- Presence of acute venous disease
- Those with sensory impairment
- Those with cardiac rhythm disorders
- Individuals with cooperation problems
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gaziosmanpaşa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 34255
Halic University
Istanbul
About this study
Official title: The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Edema, Grip Strength, Dexterity and Quality of Life in Upper Extremity Lymphedema
Lymphedema is an inflammatory disease characterized by abnormal accumulation of excess water, plasma proteins, and extravascular blood and parenchymal cells in the affected upper and lower arms, chest and/or trunk due to inadequate lymphatic transport capacity, and is associated with high-severity, recurrent soft tissue infections that can lead to sepsis and even death. Although there is no definitive treatment for lymphedema, a Complex Decongestive Treatment approach that includes manual lymph drainage, skin care, special exercises, compression and personal care has been described to slow down the progression of the disease and prevent secondary complications. In addition, parasympathetic nerve activation has been described, similar to vagus nerve activation with manual lymphatic drainage. system activation can be increased. The aim of our study was to investigate the effect of transcutaneous auricular vagus nerve stimulation on quality of life, grip strength and manual dexterity in patients with unilateral upper extremity lymphedema. It was planned as a randomized controlled experimental study. The universe of the study will consist of lymphedema patients hospitalized in Gaziosmanpaşa Physical Therapy Rehabilitation Education and Research Hospital, and the sample will consist of 27 volunteer patients who meet the inclusion and exclusion criteria. The study was planned as a single-center (Gaziosmanpaşa Education and Research Hospital). Participants will be randomly divided into three groups. The groups will be determined by simple randomization method. Only Complex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach will be applied to the first group, Complex Decongestive Treatment and sham transcutaneous vagus nerve stimulation will be applied to the second group, and transcutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Treatment to the third group. Data collected from the patients will be entered into SPSS 21.0 package program to create a data set and statistical analyses will be performed.
Read the detailed description
Demographic data related to the patient will be questioned with the Demographic Data and Anamnesis form prepared by the researchers. Circumference measurement was determined as the primary outcome measure, and gross grip strength, dexterity and quality of life were determined as the secondary outcome measures. To this end; Patients' upper extremity circumference was measured with a tape measure, their gross grip strength was measured with the Jamar Dynanometer, manual skills were measured with the 9-Hole Peg Test, upper extremity problems were measured with the Arm, Shoulder and Hand Problems Quick Questionnaire (Quick DASH), items related to people's quality of life and specific arm symptoms were measured. Lymphedema Functionality will be evaluated with the Disability and Health Questionnaire (LFOSA) and the quality of life will be evaluated with the Quality of Life Questionnaire in Upper Extremity Lymphedema Patients (ULL-27).Upper Extremity Circumference Measurement will be evaluated for both upper extremities. Assuming the wrist pivot point, markings will be made every 4 cm up to the axilla. At the marked points, the circumference will be measured with a tape measure and the difference between the affected and healthy sides will be determined.The Jamar handheld dynamometer is the most reliable and most commonly used measuring tool for measuring static grip strength. Static and dynamic measurement dynamometers are used when evaluating grip strength. These devices are hydraulic, pneumatic, mechanical and resistive devices. Measurements are generally based on the principle of compressing two bars parallel to each other. Patients are positioned and evaluated according to the holding and grip strength of the dynamometer to be used. The needle of the Jamar Hand Dynamometer shows measurements up to a maximum of 90 kg. The person will be measured in a chair without arm support, with the arm in adduction and neutral rotation, the elbow in 90 degrees of flexion, and the forearm in a neutral position. Each measurement will be repeated three times, the average will be calculated and data will be created and recorded.The Nine-Hole Peg Test, which provides information about the functional status of the hand, consists of a board with nine holes and nine nails. While the test is applied to both hands, the application begins with the dominant hand. Before proceeding with the application part, the test procedure is read to the individuals who will perform the test. In the application part, individuals are asked to place the nails into the holes as soon as possible and to remove them without wasting time and place the nails in the empty chamber on the side. Meanwhile, the application time is measured using a stopwatch and recorded in seconds.The DASH scale is a criterion developed for the evaluation of disability related to the entire upper extremity and is used to monitor the level of disability and benefit from treatment. With the DASH scale, the difficulty encountered in performing 30 different activities related to the upper extremity in daily life is evaluated. The Quick-DASH survey used in this study is a survey created by selecting and organizing the 11 most used of these activities. Each question is evaluated at 5 levels and 1 point is given if the patient can do the activity without difficulty, and 5 points are given if the patient cannot do it at all. The results are calculated with the test's own formula. It is a questionnaire with proven validity and reliability in Turkish that measures physical functions and symptoms in patients with upper extremity problems.Lymphedema Functionality, Disability, and Health Questionnaire Devooogdt et al. It was developed by Kostanoğlu et al. in 2011, and its Turkish validity and reliability study was conducted by Kostanoğlu et al. in 2016. The survey consists of 29 questions. Each question is answered using a visual analog scale ranging from 0 - 100 mm. The questionnaire has five subdomains: physical function, mental function, home activities, mobility activities and social activities. The survey takes approximately 5 minutes to complete. The Lymphedema Functionality, Disability and Health Questionnaire will be administered to patients twice, before and after treatment.The reliability and validity of the ULL-27 questionnaire in upper extremity lymphedema due to breast cancer was conducted by Ayşe Kayalı in 2017. ULL-27 is a quality of life questionnaire consisting of 27 questions that considers upper extremity lymphedema as three components (physical, psychological and social components). The first 15 questions evaluate the physical component, questions between 16-22 evaluate the psychological component, and questions between 23-27 evaluate the social component. It is a 5-point Likert type scale (1 = strongly disagree, 5 = strongly agree). The lowest score is 27 and the highest score is 135. A high score from the scale indicates that lymphedema negatively affects the quality of life. The physical score consists of a total of fifteen questions and the person's score is between at least 15 and 75. The psychological score consists of seven questions with a minimum of 7 and a maximum of 35 points. There are five questions for the social score, with a minimum score of 5 and a maximum score of 25. For a total score of 27 questions, 1 of all questions will receive at least 27 points, and the person who chooses 5 of all questions will receive a maximum of 135 points.
- Conditions
- Quality of Life, Lymphedema, Hand Grasp, Grip, Strength, Edema
- Being tested
- Complex Decongestive Treatment, Sham transcutaneous vagus nerve stimulation, Transcutaneous Auricular Vagus Nerve Stimulation, Exercise
- Keywords
- Lymphedema, Hand Grip, Grip Strength, Quality of Life
- Medical subject headings
- Lymphedema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive TreatmentOther
Complex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach. It will be applied 5 days a week for 3 weeks
Sham transcutaneous vagus nerve stimulationOther
In sham transcutaneous vagus nerve stimulation application, the device electrode will be placed in the superior scapha region of the outer ear, where the vagus nerve has no innervation, and no current will be given.Complex Decongestive Therapy and sham transcutaneous vagus nerve stimulation.It will be applied 5 days a week for 3 weeks.
Transcutaneous Auricular Vagus Nerve StimulationOther
Transcutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Therapy.It will be applied 5 days a week for 3 weeks.
ExerciseOther
Patients will undergo lymphedema-specific exercises 5 days a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Complex Decongestive Treatment | Placebo comparator | Complex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach. It will be applied 5 days a week for 3 weeks. Receives: Other: Complex Decongestive Treatment; Other: Exercise |
| Sham transcutaneous vagus nerve stimulation | Sham comparator | In sham transcutaneous vagus nerve stimulation application, the device electrode will be placed in the superior scapha region of the outer ear, where the vagus nerve has no innervation, and no current will be given.Complex Decongestive Therapy and sham transcutaneous vagus nerve stimulation.It will be applied 5 days a week for 3 weeks. Receives: Other: Complex Decongestive Treatment; Other: Sham transcutaneous vagus nerve stimulation; Other: Exercise |
| Transcutaneous vagus nerve stimulation | Active comparator | Transcutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Therapy.It will be applied 5 days a week for 3 weeks. Receives: Other: Complex Decongestive Treatment; Other: Transcutaneous Auricular Vagus Nerve Stimulation; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extremity circumference measurement as the primary outcome measure
Upper Extremity Circumference Measurement will be evaluated for both upper extremities. Assuming the wrist pivot point, markings will be made every 4 cm up to the axilla. The difference between the affected and healthy sides will be determined by measuring the circumference with a tape measure at the marked points.
Measured: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Secondary outcomes (3)
Gross grip strength
Jamar hand dynamometer is the reliable and most commonly used measurement tool that measures static grip strength. Static and dynamic measurement dynamometers are used when evaluating grip strength. These devices are hydraulic, pneumatic, mechanical and resistive devices. Measurements are generally It is based on the principle of compressing two bars parallel to each other. Patients are positioned and evaluated according to the holding and grip strength of the dynamometer to be used. The needle of the Jamar Hand Dynamometer shows measurements up to a maximum of 90 kg.
The person will be measured in a chair without arm support, with the arm in adduction and neutral rotation, the elbow in 90 flexion, and the forearm in neutral position. Each measurement will be repeated three times, the average will be calculated and data will be created and recorded.
Measured: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Manual Dexterity
The Nine-Hole Peg Test, which provides information about the functional status of the hand, consists of a board with nine holes and nine nails. While the test is applied to both hands, the application begins with the dominant hand. Before proceeding with the application part, the test procedure is read to the individuals who will perform the test. In the application part, individuals are asked to place the nails into the holes as soon as possible and to remove them without wasting time and place the nails in the empty chamber located on the side. Meanwhile, the application time is measured using a stopwatch and recorded in seconds.
Measured: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Life Quality
The Lymphedema Functioning, Disability and Health Questionnaire consists of 29 questions. Each question is answered using a visual analog scale ranging from 0 - 100 mm. The questionnaire has five subdomains: physical function, mental function, home activities, mobility activities and social activities. The survey takes approximately 5 minutes to complete. The Lymphedema Functioning, Disability and Health Survey will be administered to patients twice, before and after treatment. It is a quality of life survey consisting of 27 questions. It is a 5-point Likert type scale (1=strongly disagree, 5=strongly agree). The lowest score is 27 and the highest score is 135. A high score from the scale indicates that lymphedema negatively affects the quality of life.
Measured: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start11 Sep 2023
- Primary completion11 Sep 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Demographic data related to the patient will be questioned with the Demographic Data and Anamnesis form prepared by the researchers. Circumference measurement was determined as the primary outcome measure, and gross grip strength, dexterity and quality of life were determined as the secondary outcome measures. To this end; Patients' upper extremity circumference was measured with a tape measure, gross grip strength was measured with Jamar Dynanometer, manual dexterity was measured with 9-Hole Peg Test, upper extremity problems were measured with Arm, Shoulder and Hand Problems Quick Questionnaire (Quick DASH), items related to people's quality of life and specific arm symptoms were measured. Lymphedema Functionality will be evaluated with the Disability and Health Survey (LFÖSA) and quality of life will be evaluated with the Quality of Life Questionnaire in Upper Extremity Lymphedema Patients (ULL-27).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seda Saka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda Saka, Halic University
- Investigators
- Kevser Gümüşsu, MD, Study director, Gaziosmanpaşa Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069908
- Sponsor's protocol ID
- OzgeO
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capilupi MJ, Kerath SM, Becker LB. Vagus Nerve Stimulation and the Cardiovascular System. Cold Spring Harb Perspect Med. 2020 Feb 3;10(2):a034173. doi: 10.1101/cshperspect.a034173.
PubMed 31109966Cerritelli F, Frasch MG, Antonelli MC, Viglione C, Vecchi S, Chiera M, Manzotti A. A Review on the Vagus Nerve and Autonomic Nervous System During Fetal Development: Searching for Critical Windows. Front Neurosci. 2021 Sep 20;15:721605. doi: 10.3389/fnins.2021.721605. eCollection 2021.
PubMed 34616274de Sire A, Losco L, Lippi L, Spadoni D, Kaciulyte J, Sert G, Ciamarra P, Marcasciano M, Cuomo R, Bolletta A, Invernizzi M, Cigna E. Surgical Treatment and Rehabilitation Strategies for Upper and Lower Extremity Lymphedema: A Comprehensive Review. Medicina (Kaunas). 2022 Jul 19;58(7):954. doi: 10.3390/medicina58070954.
PubMed 35888673Drouin JS, Pfalzer L, Shim JM, Kim SJ. Comparisons between Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation on Functional Constipation Outcomes: A Randomized, Controlled Trial. Int J Environ Res Public Health. 2020 Jun 1;17(11):3924. doi: 10.3390/ijerph17113924.
PubMed 32492920Farmer AD, Strzelczyk A, Finisguerra A, Gourine AV, Gharabaghi A, Hasan A, Burger AM, Jaramillo AM, Mertens A, Majid A, Verkuil B, Badran BW, Ventura-Bort C, Gaul C, Beste C, Warren CM, Quintana DS, Hammerer D, Freri E, Frangos E, Tobaldini E, Kaniusas E, Rosenow F, Capone F, Panetsos F, Ackland GL, Kaithwas G, O'Leary GH, Genheimer H, Jacobs HIL, Van Diest I, Schoenen J, Redgrave J, Fang J, Deuchars J, Szeles JC, Thayer JF, More K, Vonck K, Steenbergen L, Vianna LC, McTeague LM, Ludwig M, Veldhuizen MG, De Couck M, Casazza M, Keute M, Bikson M, Andreatta M, D'Agostini M, Weymar M, Betts M, Prigge M, Kaess M, Roden M, Thai M, Schuster NM, Montano N, Hansen N, Kroemer NB, Rong P, Fischer R, Howland RH, Sclocco R, Sellaro R, Garcia RG, Bauer S, Gancheva S, Stavrakis S, Kampusch S, Deuchars SA, Wehner S, Laborde S, Usichenko T, Polak T, Zaehle T, Borges U, Teckentrup V, Jandackova VK, Napadow V, Koenig J. International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020). Front Hum Neurosci. 2021 Mar 23;14:568051. doi: 10.3389/fnhum.2020.568051. eCollection 2020.
PubMed 33854421Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.
PubMed 24175606Garcia Nores GD, Ly CL, Savetsky IL, Kataru RP, Ghanta S, Hespe GE, Rockson SG, Mehrara BJ. Regulatory T Cells Mediate Local Immunosuppression in Lymphedema. J Invest Dermatol. 2018 Feb;138(2):325-335. doi: 10.1016/j.jid.2017.09.011. Epub 2017 Sep 20.
PubMed 28942366Hilz MJ. Transcutaneous vagus nerve stimulation - A brief introduction and overview. Auton Neurosci. 2022 Dec;243:103038. doi: 10.1016/j.autneu.2022.103038. Epub 2022 Sep 27.
PubMed 36201901Ahmed U, Chang YC, Zafeiropoulos S, Nassrallah Z, Miller L, Zanos S. Strategies for precision vagus neuromodulation. Bioelectron Med. 2022 May 30;8(1):9. doi: 10.1186/s42234-022-00091-1.
PubMed 35637543
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Edema, Grip Strength, Dexterity and Quality of Life in Upper Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT06069908
- Acronym / sponsor ID
- OzgeO
- Conditions
- Quality of Life, Lymphedema, Hand Grasp, Grip, Strength, Edema
- Keywords
- Lymphedema, Hand Grip, Grip Strength, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Seda SakaUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 6 Oct 2023 (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.
Lymphedema is an inflammatory disease characterized by abnormal accumulation of excess water, plasma proteins, and extravascular blood and parenchymal cells in the affected upper and lower arms, chest and/or trunk due to inadequate lymphatic transport capacity, and is associated with high-severity, recurrent soft tissue infections that can lead to sepsis and even death. Although there is no definitive treatment for lymphedema, a Complex Decongestive Treatment approach that includes manual lymph drainage, skin care, special exercises, compression and personal care has been described to slow down the progression of the disease and prevent secondary complications. In addition, parasympathetic nerve activation has been described, similar to vagus nerve activation with manual lymphatic drainage. system activation can be increased. The aim of our study was to investigate the effect of transcutaneous auricular vagus nerve stimulation on quality of life, grip strength and manual dexterity in patients with unilateral upper extremity lymphedema. It was planned as a randomized controlled experimental study. The universe of the study will consist of lymphedema patients hospitalized in Gaziosmanpaşa Physical Therapy Rehabilitation Education and Research Hospital, and the sample will consist of 27 volunteer patients who meet the inclusion and exclusion criteria. The study was planned as a single-center (Gaziosmanpaşa Education and Research Hospital). Participants will be randomly divided into three groups. The groups will be determined by simple randomization method. Only Complex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach will be applied to the first group, Complex Decongestive Treatment and sham transcutaneous vagus nerve stimulation will be applied to the second group, and transcutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Treatment to the third group. Data collected from the patients will be entered into SPSS 21.0 package program to create a data set and statistical analyses will be performed.
Detailed description
Demographic data related to the patient will be questioned with the Demographic Data and Anamnesis form prepared by the researchers. Circumference measurement was determined as the primary outcome measure, and gross grip strength, dexterity and quality of life were determined as the secondary outcome measures. To this end; Patients' upper extremity circumference was measured with a tape measure, their gross grip strength was measured with the Jamar Dynanometer, manual skills were measured with the 9-Hole Peg Test, upper extremity problems were measured with the Arm, Shoulder and Hand Problems Quick Questionnaire (Quick DASH), items related to people's quality of life and specific arm symptoms were measured. Lymphedema Functionality will be evaluated with the Disability and Health Questionnaire (LFOSA) and the quality of life will be evaluated with the Quality of Life Questionnaire in Upper Extremity Lymphedema Patients (ULL-27).Upper Extremity Circumference Measurement will be evaluated for both upper extremities. Assuming the wrist pivot point, markings will be made every 4 cm up to the axilla. At the marked points, the circumference will be measured with a tape measure and the difference between the affected and healthy sides will be determined.The Jamar handheld dynamometer is the most reliable and most commonly used measuring tool for measuring static grip strength. Static and dynamic measurement dynamometers are used when evaluating grip strength. These devices are hydraulic, pneumatic, mechanical and resistive devices. Measurements are generally based on the principle of compressing two bars parallel to each other. Patients are positioned and evaluated according to the holding and grip strength of the dynamometer to be used. The needle of the Jamar Hand Dynamometer shows measurements up to a maximum of 90 kg. The person will be measured in a chair without arm support, with the arm in adduction and neutral rotation, the elbow in 90 degrees of flexion, and the forearm in a neutral position. Each measurement will be repeated three times, the average will be calculated and data will be created and recorded.The Nine-Hole Peg Test, which provides information about the functional status of the hand, consists of a board with nine holes and nine nails. While the test is applied to both hands, the application begins with the dominant hand. Before proceeding with the application part, the test procedure is read to the individuals who will perform the test. In the application part, individuals are asked to place the nails into the holes as soon as possible and to remove them without wasting time and place the nails in the empty chamber on the side. Meanwhile, the application time is measured using a stopwatch and recorded in seconds.The DASH scale is a criterion developed for the evaluation of disability related to the entire upper extremity and is used to monitor the level of disability and benefit from treatment. With the DASH scale, the difficulty encountered in performing 30 different activities related to the upper extremity in daily life is evaluated. The Quick-DASH survey used in this study is a survey created by selecting and organizing the 11 most used of these activities. Each question is evaluated at 5 levels and 1 point is given if the patient can do the activity without difficulty, and 5 points are given if the patient cannot do it at all. The results are calculated with the test's own formula. It is a questionnaire with proven validity and reliability in Turkish that measures physical functions and symptoms in patients with upper extremity problems.Lymphedema Functionality, Disability, and Health Questionnaire Devooogdt et al. It was developed by Kostanoğlu et al. in 2011, and its Turkish validity and reliability study was conducted by Kostanoğlu et al. in 2016. The survey consists of 29 questions. Each question is answered using a visual analog scale ranging from 0 - 100 mm. The questionnaire has five subdomains: physical function, mental function, home activities, mobility activities and social activities. The survey takes approximately 5 minutes to complete. The Lymphedema Functionality, Disability and Health Questionnaire will be administered to patients twice, before and after treatment.The reliability and validity of the ULL-27 questionnaire in upper extremity lymphedema due to breast cancer was conducted by Ayşe Kayalı in 2017. ULL-27 is a quality of life questionnaire consisting of 27 questions that considers upper extremity lymphedema as three components (physical, psychological and social components). The first 15 questions evaluate the physical component, questions between 16-22 evaluate the psychological component, and questions between 23-27 evaluate the social component. It is a 5-point Likert type scale (1 = strongly disagree, 5 = strongly agree). The lowest score is 27 and the highest score is 135. A high score from the scale indicates that lymphedema negatively affects the quality of life. The physical score consists of a total of fifteen questions and the person's score is between at least 15 and 75. The psychological score consists of seven questions with a minimum of 7 and a maximum of 35 points. There are five questions for the social score, with a minimum score of 5 and a maximum score of 25. For a total score of 27 questions, 1 of all questions will receive at least 27 points, and the person who chooses 5 of all questions will receive a maximum of 135 points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Demographic data related to the patient will be questioned with the Demographic Data and Anamnesis form prepared by the researchers. Circumference measurement was determined as the primary outcome measure, and gross grip strength, dexterity and quality of life were determined as the secondary outcome measures. To this end; Patients' upper extremity circumference was measured with a tape measure, gross grip strength was measured with Jamar Dynanometer, manual dexterity was measured with 9-Hole Peg Test, upper extremity problems were measured with Arm, Shoulder and Hand Problems Quick Questionnaire (Quick DASH), items related to people's quality of life and specific arm symptoms were measured. Lymphedema Functionality will be evaluated with the Disability and Health Survey (LFÖSA) and quality of life will be evaluated with the Quality of Life Questionnaire in Upper Extremity Lymphedema Patients (ULL-27).
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive Treatment | Placebo comparator | Other: Complex Decongestive Treatment, Other: ExerciseComplex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach. It will be applied 5 days a week for 3 weeks. |
| Sham transcutaneous vagus nerve stimulation | Sham comparator | Other: Complex Decongestive Treatment, Other: Sham transcutaneous vagus nerve stimulation, Other: ExerciseIn sham transcutaneous vagus nerve stimulation application, the device electrode will be placed in the superior scapha region of the outer ear, where the vagus nerve has no innervation, and no current will be given.Complex Decongestive Therapy and sham transcutaneous vagus nerve stimulation.It will be applied 5 days a week for 3 weeks. |
| Transcutaneous vagus nerve stimulation | Active comparator | Other: Complex Decongestive Treatment, Other: Transcutaneous Auricular Vagus Nerve Stimulation, Other: ExerciseTranscutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Therapy.It will be applied 5 days a week for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 18-65
- Diagnosed with secondary lymphedema disease by the physician
- Minimum of three months after surgery
- Stage 2 and 3 patients
- Native speaker Turkish
Key exclusion criteria (8 listed)
- Individuals with any neurological or orthopedic problems in the upper extremity
- Individuals undergoing upper extremity surgery
- Presence of cardiac edema
- Presence of arterial disease
- Presence of acute venous disease
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 |
|---|---|---|
| Complex Decongestive TreatmentComplex Decongestive Treatment (manual lymph drainage, skin care, special exercises, compression) approach. It will be applied 5 days a week for 3 weeks | Other | Complex Decongestive Treatment, Sham transcutaneous vagus nerve stimulation, Transcutaneous vagus nerve stimulation |
| Sham transcutaneous vagus nerve stimulationIn sham transcutaneous vagus nerve stimulation application, the device electrode will be placed in the superior scapha region of the outer ear, where the vagus nerve has no innervation, and no current will be given.Complex Decongestive Therapy and sham transcutaneous vagus nerve stimulation.It will be applied 5 days a week for 3 weeks. | Other | Sham transcutaneous vagus nerve stimulation |
| Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous vagus nerve stimulation will be applied in addition to Complex Decongestive Therapy.It will be applied 5 days a week for 3 weeks. | Other | Transcutaneous vagus nerve stimulation |
| ExercisePatients will undergo lymphedema-specific exercises 5 days a week for 3 weeks. | Other | Complex Decongestive Treatment, Sham transcutaneous vagus nerve stimulation, Transcutaneous vagus nerve stimulation |
Primary outcome
Extremity circumference measurement as the primary outcome measure
Time frame: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Upper Extremity Circumference Measurement will be evaluated for both upper extremities. Assuming the wrist pivot point, markings will be made every 4 cm up to the axilla. The difference between the affected and healthy sides will be determined by measuring the circumference with a tape measure at the marked points.
3 secondary outcomes
Gross grip strength
Time frame: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Manual Dexterity
Time frame: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
Life Quality
Time frame: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.
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 5 Aug 2025.
- Background: PubMed 31109966Capilupi MJ, Kerath SM, Becker LB. Vagus Nerve Stimulation and the Cardiovascular System. Cold Spring Harb Perspect Med. 2020 Feb 3;10(2):a034173. doi: 10.1101/cshperspect.a034173.
- Background: PubMed 34616274Cerritelli F, Frasch MG, Antonelli MC, Viglione C, Vecchi S, Chiera M, Manzotti A. A Review on the Vagus Nerve and Autonomic Nervous System During Fetal Development: Searching for Critical Windows. Front Neurosci. 2021 Sep 20;15:721605. doi: 10.3389/fnins.2021.721605. eCollection 2021.
- Background: PubMed 35888673de Sire A, Losco L, Lippi L, Spadoni D, Kaciulyte J, Sert G, Ciamarra P, Marcasciano M, Cuomo R, Bolletta A, Invernizzi M, Cigna E. Surgical Treatment and Rehabilitation Strategies for Upper and Lower Extremity Lymphedema: A Comprehensive Review. Medicina (Kaunas). 2022 Jul 19;58(7):954. doi: 10.3390/medicina58070954.
- Background: PubMed 32492920Drouin JS, Pfalzer L, Shim JM, Kim SJ. Comparisons between Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation on Functional Constipation Outcomes: A Randomized, Controlled Trial. Int J Environ Res Public Health. 2020 Jun 1;17(11):3924. doi: 10.3390/ijerph17113924.
- Background: PubMed 33854421Farmer AD, Strzelczyk A, Finisguerra A, Gourine AV, Gharabaghi A, Hasan A, Burger AM, Jaramillo AM, Mertens A, Majid A, Verkuil B, Badran BW, Ventura-Bort C, Gaul C, Beste C, Warren CM, Quintana DS, Hammerer D, Freri E, Frangos E, Tobaldini E, Kaniusas E, Rosenow F, Capone F, Panetsos F, Ackland GL, Kaithwas G, O'Leary GH, Genheimer H, Jacobs HIL, Van Diest I, Schoenen J, Redgrave J, Fang J, Deuchars J, Szeles JC, Thayer JF, More K, Vonck K, Steenbergen L, Vianna LC, McTeague LM, Ludwig M, Veldhuizen MG, De Couck M, Casazza M, Keute M, Bikson M, Andreatta M, D'Agostini M, Weymar M, Betts M, Prigge M, Kaess M, Roden M, Thai M, Schuster NM, Montano N, Hansen N, Kroemer NB, Rong P, Fischer R, Howland RH, Sclocco R, Sellaro R, Garcia RG, Bauer S, Gancheva S, Stavrakis S, Kampusch S, Deuchars SA, Wehner S, Laborde S, Usichenko T, Polak T, Zaehle T, Borges U, Teckentrup V, Jandackova VK, Napadow V, Koenig J. International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020). Front Hum Neurosci. 2021 Mar 23;14:568051. doi: 10.3389/fnhum.2020.568051. eCollection 2020.
- Background: PubMed 24175606Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.
- Background: PubMed 28942366Garcia Nores GD, Ly CL, Savetsky IL, Kataru RP, Ghanta S, Hespe GE, Rockson SG, Mehrara BJ. Regulatory T Cells Mediate Local Immunosuppression in Lymphedema. J Invest Dermatol. 2018 Feb;138(2):325-335. doi: 10.1016/j.jid.2017.09.011. Epub 2017 Sep 20.
- Background: PubMed 36201901Hilz MJ. Transcutaneous vagus nerve stimulation - A brief introduction and overview. Auton Neurosci. 2022 Dec;243:103038. doi: 10.1016/j.autneu.2022.103038. Epub 2022 Sep 27.
- Results publication: PubMed 35637543Ahmed U, Chang YC, Zafeiropoulos S, Nassrallah Z, Miller L, Zanos S. Strategies for precision vagus neuromodulation. Bioelectron Med. 2022 May 30;8(1):9. doi: 10.1186/s42234-022-00091-1.
- Individual participant dataSharing planned: No
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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.
Kevser Gümüşsu, MD study director
Gaziosmanpaşa Eğitim ve Araştırma Hastanesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Treatment, Transcutaneous Auricular Vagus Nerve Stimulation and Exercise in people with Quality of Life and Lymphedema, run by Seda Saka at 2 sites 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 6 inclusion and 8 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 5 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 2 sites 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. Some participants in this study may receive a placebo. 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?
Extremity circumference measurement as the primary outcome measure (time frame: It will be evaluated before starting and at the end of treatment. It will take 3 weeks.). 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 NCT06069908, which also lists 9 linked publications.
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 5 Aug 2025.