Being in the 18-50 Age PopulationNCT05586412
Efficacy of Auricular Vagus Nerve Stimulation
A study testing vagus nerve stimulation in people with Being in the 18-50 Age Population and Being Diagnosed With Frozen Shoulder by a Specialist Physician, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Auricular Vagus Nerve Stimulation, a non-invasive method, will be used in the study. Studies have shown that vagus nerve stimulation combined with a large vagal nerve network can have a neuromodulatory effect that will activate some natural protective pathways to improve health. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Being in the 18-50 Age Population, Being Diagnosed With Frozen Shoulder by a Specialist Physician, Volunteer to Participate in the Study
- What is being tested?
- vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2022to 20 Dec 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be in the 18-50 age population, to be diagnosed with Frozen Shoulder by a specialist physician
Who cannot join
- Patients with neurological deficits, neuropathic disorders, chronic inflammation, other musculoskeletal disorders in the upper extremities, pregnant women, and patients who had additional changes in their current treatment other than vagus nerve stimulation were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Malatya Sevgi Hospital
Malatya, Battalgazi̇, 44960
BURAK BUĞDAY, (0422) 325 55 55 ext. +90
About this study
Official title: Evaluation of Auricular Vagus Nerve Stimulation and the Effectiveness of Home Exercise Program in Frozen Shoulder Patients
Auricular Vagus Nerve Stimulation, a non-invasive method, will be used in the study. Studies have shown that vagus nerve stimulation combined with a large vagal nerve network can have a neuromodulatory effect that will activate some natural protective pathways to improve health. Clinically, vagus nerve stimulation is FDA-approved for epilepsy, treatment-resistant depression, and morbid obesity. Since OSS dysfunction is also involved in the etiology of DO and there is no study on the effectiveness of vagus nerve stimulation in this disease, this study is planned to reveal the effectiveness of auricular vagus nerve stimulation and home exercise program in DO patients.
Read the detailed description
The shoulder junction is a very dynamic structure that has a wide arc of motion and can move in sagittal, vertical and transverse planes, and provides the connection between the trunk and the upper extremity. Due to this dynamic structure, the shoulder junction is a joint where soft tissue pathologies are common. One of the most common of these pathologies is adhesive capsulitis or frozen shoulder (DO). DO has been defined by different names and with some minor differences in the literature for over 100 years. It has been defined by various names such as adherent obliterative bursitis, adhesive bursitis, periarticular fibrositis, scapulohumeral periarthritis, Duplay periarthritis, adhesive capsulitis. DO was first defined as "scapulohumeral periarthritis" in 1896 by Duplay. In 1934, Codman used the term "frozen shoulder" and suggested that it is seen together with rotator cuff tendinitis. The most widely accepted is the definition made by Neviaser in 1945. It is a disease picture characterized by pain and limitation of movement in the shoulder joint, which is defined as inflammation in the capsule and synovium first, followed by adhesion formations, especially in the axillary fold and the attachment of the capsule to the anatomical neck of the humerus.
Although the exact mechanism of action of vagus nerve stimulation is not known, studies on humans have shown that it affects many areas of the brain at the subcortical and cortical level. A high peripheral sympathetic tone causes regional ischemia, which causes widespread pain. Therapeutic interventions that result in vasodilation (eg, exercise) and appropriate autonomic changes have proven to be effective on pain. The vagus nerve, the "great perfect protector" of the body, encompasses a complex neuro-endocrine-immune network that maintains homeostasis. With reciprocal neural connections to multiple areas of the brain, the vagus nerve serves as a control center that integrates sensitive information and provides appropriate feedback responses. Recent studies show that the vagus nerve is involved in inflammation, mood and pain regulation. All of these can be modulated with vagus nerve stimulation. Vagus nerve stimulation, together with an extensive vagal nerve network, can exert a neuromodulatory effect that will activate some natural protective pathways for health restoration.
Recent preclinical studies show that vagus nerve stimulation is very potent and effective in modulating pain in humans. A medical device allowed the auricular branch of the vagus nerve to be stimulated without any surgery. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. As a result of the studies, there is a possibility that Frozen Shoulder is a disease that occurs with OSS disorder. Vagus nerve stimulation can be used as an adjunct therapy to correct OSS disorder. Since there is no study in the literature on vagus nerve stimulation in Frozen Shoulder, such a study was considered.
- Conditions
- Being in the 18-50 Age Population, Being Diagnosed With Frozen Shoulder by a Specialist Physician, Volunteer to Participate in the Study
- Being tested
- vagus nerve stimulation
- Keywords
- frozen shoulder, valgus nerve stimulation, transcutaneous, auricular, home exercises program
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagus nerve stimulationDevice
Also called exercise therapy group, exercise-vagus stimulation group
Vagus stimulation, TENS device with specially designed and shaped surfaces that can be shaped according to the magnifying ear will be performed. The electrodes will be placed in such a way that the tragus is facing the inner and outer world. The wave formula is biphasic asymmetrical, pulses less than 500 microseconds and 10 hertz for 30 minutes. will be custom-made and the amplitude will be set as the sensory threshold.
| Study group | Role | What they receive |
|---|---|---|
| exercise therapy group | Experimental | Exercise therapy group; joint range of motion exercises including the upper extremity, strengthening, stretching, isometric and posture exercise program will be given. These exercises are in the form of a home program and will be asked to do 2 sets a day, 5 days a week, and 10 repetitions of each movement for 4 weeks. Receives: Device: vagus nerve stimulation |
| vagus stimulation group | Experimental | To the patients in the vagus stimulation treatment group; Auricular vagus nerve stimulation in the physical therapy and rehabilitation unit, 20 sessions in total, 5 days a week, and 30 minutes each session. will be applied. Patients will be treated in the form of daily arrival and departure. Vagus nerve stimulation will be performed using a TENS device with specially designed ear-shaped surface electrodes, the size of which can be selected according to any size ear. The electrodes will be placed on the inner and outer surface of the tragus and the concha. Waveform biphasic asymmetrical, pulse duration less than 500 microseconds and frequency of 10 hertz for 30 minutes. been applied continuously throughout and the amplitude will be adjusted according to the sensory threshold level. Receives: Device: vagus nerve stimulation |
| exercise-vagus stimulation group | Experimental | Exercise and vagus stimulation treatment group; Both the applications made to the patients in the vagus stimulation group and the same exercises given to the patients in the exercise therapy group will be given as a home program. Patients in all groups will be evaluated with different parameters twice, before and after the treatment. Receives: Device: vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinesiophobia assessment
Tampa Kinesiophobia Scale were used. The Tampa Kinesiophobia Scale (TKS) is one of them, and it's commonly used in the literature to assess kinesiophobia. It has 17 questions designed to assess fear of moving.
Measured: 6 months
Pain Assessment
Pain Assessment Visual Analogue Scale (VAS) was used. On a 10-centimeter (cm) horizontal line, start 0 (no pain) and finish 10 (unbearable pain) are marked and the subjects were asked to place a mark on this horizontal line according to the degree of pain they felt. The point marked on the line was then measured with the help of a ruler and recorded as the VAS value in cm.
Measured: 6 months
Depression Assessment
Depression Severity Assessment, The Beck Depression Inventory (BDI) was employed, which consists of 21 questions. The scale has a range of 0 to 84 points.
Measured: 6 months
joint range of motion assessment
ROM will be evaluated with the goniometric measurement. This measurement method is an objective method used in the clinical evaluation of joint range of motion. Shoulder flexion, extension, abduction, adduction, external and internal rotation movements of the patients will be measured 3 times passively and actively with a universal goniometer.
Measured: 6 months
functional limitation and disability status assessment
In our study, the Arm, Shoulder and Hand Problems Questionnaire (DASH), which is more preferred in the clinic, was used to evaluate upper extremity functional limitation and disability, which consists of 3 parts. The questionnaire consists of 30 questions that determine the function score in the first part; 21 questions about difficulty in activities of daily living, 5 questions about symptoms (pain, tingling, stiffness, activity-related pain), each of the remaining questions evaluates the patient's social function, work, sleep and self-confidence. The second part of the questionnaire is answered optionally and is a business model consisting of 4 questions. In the third part of the questionnaire, there is a section consisting of 4 elective questions that determine the disability level of patients who are sports-musician models, who want high performance, who are involved in sports or music.
Measured: 6 months
Quality of Life assessment
In our study, the widely preferred SF-36 form, consisting of 36 items, was used to evaluate the quality of life in patients with musculoskeletal disorders, whose reliability and validity have been demonstrated by studies. The 36 items in this form cover 8 different health-related dimensions: physical, emotional and social function, physical role, mental health, general health, pain and vitality. For these dimensions, the scores of the items are coded and converted into a scale between 0-100 points. The scale that evaluates the scores of each subgroup between 0-100; 0 indicates "worst health" status, 100 indicates "best health" status.
Measured: 6 months
Shoulder Pain and Disability Assessment
The Shoulder Pain and Disability Index, developed by Roach et al. in 1911, was used to assess the level of disability by questioning the level of limitation experienced by the participants during personal carrying, care and dressing activities, and to measure current shoulder pain and disability. The Spadi scale consists of 2 subscales of pain (5 questions) and disability (8 questions) and 13 subheadings. Pain and disability subscales are calculated between 0 (no pain) - 100 (worst pain imaginable). As a result of the survey, 3 different scores are obtained as Obstacle, Pain and Total score, each of which is scored separately. The answers given to the questions in the scale are calculated as the last percentile. The higher the total score on the scale, the higher the person's level of pain or disability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start7 Jul 2022
- Primary completion3 Nov 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Being in the 18-50 Age PopulationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomization will be made by drawing lots. 30 patients will be included in the exercise group, 30 patients in the vagus stimulation group, and 30 patients in the exercise and vagus stimulation group.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Buğday, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586412
- Sponsor's protocol ID
- 2021/126
- Status last verified
- Oct 2022
- First submitted
- 16 Aug 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Auricular Vagus Nerve Stimulation and the Effectiveness of Home Exercise Program in Frozen Shoulder Patients
- ClinicalTrials.gov ID
- NCT05586412
- Acronym / sponsor ID
- 2021/126
- Conditions
- Being in the 18-50 Age Population, Being Diagnosed With Frozen Shoulder by a Specialist Physician, Volunteer to Participate in the Study
- Keywords
- frozen shoulder, valgus nerve stimulation, transcutaneous, auricular, home exercises program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 3 Nov 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 19 Oct 2022 (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.
Auricular Vagus Nerve Stimulation, a non-invasive method, will be used in the study. Studies have shown that vagus nerve stimulation combined with a large vagal nerve network can have a neuromodulatory effect that will activate some natural protective pathways to improve health. Clinically, vagus nerve stimulation is FDA-approved for epilepsy, treatment-resistant depression, and morbid obesity. Since OSS dysfunction is also involved in the etiology of DO and there is no study on the effectiveness of vagus nerve stimulation in this disease, this study is planned to reveal the effectiveness of auricular vagus nerve stimulation and home exercise program in DO patients.
Detailed description
The shoulder junction is a very dynamic structure that has a wide arc of motion and can move in sagittal, vertical and transverse planes, and provides the connection between the trunk and the upper extremity. Due to this dynamic structure, the shoulder junction is a joint where soft tissue pathologies are common. One of the most common of these pathologies is adhesive capsulitis or frozen shoulder (DO). DO has been defined by different names and with some minor differences in the literature for over 100 years. It has been defined by various names such as adherent obliterative bursitis, adhesive bursitis, periarticular fibrositis, scapulohumeral periarthritis, Duplay periarthritis, adhesive capsulitis. DO was first defined as "scapulohumeral periarthritis" in 1896 by Duplay. In 1934, Codman used the term "frozen shoulder" and suggested that it is seen together with rotator cuff tendinitis. The most widely accepted is the definition made by Neviaser in 1945. It is a disease picture characterized by pain and limitation of movement in the shoulder joint, which is defined as inflammation in the capsule and synovium first, followed by adhesion formations, especially in the axillary fold and the attachment of the capsule to the anatomical neck of the humerus.
Although the exact mechanism of action of vagus nerve stimulation is not known, studies on humans have shown that it affects many areas of the brain at the subcortical and cortical level. A high peripheral sympathetic tone causes regional ischemia, which causes widespread pain. Therapeutic interventions that result in vasodilation (eg, exercise) and appropriate autonomic changes have proven to be effective on pain. The vagus nerve, the "great perfect protector" of the body, encompasses a complex neuro-endocrine-immune network that maintains homeostasis. With reciprocal neural connections to multiple areas of the brain, the vagus nerve serves as a control center that integrates sensitive information and provides appropriate feedback responses. Recent studies show that the vagus nerve is involved in inflammation, mood and pain regulation. All of these can be modulated with vagus nerve stimulation. Vagus nerve stimulation, together with an extensive vagal nerve network, can exert a neuromodulatory effect that will activate some natural protective pathways for health restoration.
Recent preclinical studies show that vagus nerve stimulation is very potent and effective in modulating pain in humans. A medical device allowed the auricular branch of the vagus nerve to be stimulated without any surgery. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. As a result of the studies, there is a possibility that Frozen Shoulder is a disease that occurs with OSS disorder. Vagus nerve stimulation can be used as an adjunct therapy to correct OSS disorder. Since there is no study in the literature on vagus nerve stimulation in Frozen Shoulder, such a study was considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomization will be made by drawing lots. 30 patients will be included in the exercise group, 30 patients in the vagus stimulation group, and 30 patients in the exercise and vagus stimulation group.
| Arm | Type | Receives |
|---|---|---|
| exercise therapy group | Experimental | Device: vagus nerve stimulationExercise therapy group; joint range of motion exercises including the upper extremity, strengthening, stretching, isometric and posture exercise program will be given. These exercises are in the form of a home program and will be asked to do 2 sets a day, 5 days a week, and 10 repetitions of each movement for 4 weeks. |
| vagus stimulation group | Experimental | Device: vagus nerve stimulationTo the patients in the vagus stimulation treatment group; Auricular vagus nerve stimulation in the physical therapy and rehabilitation unit, 20 sessions in total, 5 days a week, and 30 minutes each session. will be applied. Patients will be treated in the form of daily arrival and departure. Vagus nerve stimulation will be performed using a TENS device with specially designed ear-shaped surface electrodes, the size of which can be selected according to any size ear. The electrodes will be placed on the inner and outer surface of the tragus and the concha. Waveform biphasic asymmetrical, pulse duration less than 500 microseconds and frequency of 10 hertz for 30 minutes. been applied continuously throughout and the amplitude will be adjusted according to the sensory threshold level. |
| exercise-vagus stimulation group | Experimental | Device: vagus nerve stimulationExercise and vagus stimulation treatment group; Both the applications made to the patients in the vagus stimulation group and the same exercises given to the patients in the exercise therapy group will be given as a home program. Patients in all groups will be evaluated with different parameters twice, before and after the treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be in the 18-50 age population, to be diagnosed with Frozen Shoulder by a specialist physician
Key exclusion criteria (1 listed)
- Patients with neurological deficits, neuropathic disorders, chronic inflammation, other musculoskeletal disorders in the upper extremities, pregnant women, and patients who had additional changes in their current treatment other than vagus nerve stimulation were excluded from the study.
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 |
|---|---|---|
| vagus nerve stimulationAlso: exercise therapy group, exercise-vagus stimulation groupVagus stimulation, TENS device with specially designed and shaped surfaces that can be shaped according to the magnifying ear will be performed. The electrodes will be placed in such a way that the tragus is facing the inner and outer world. The wave formula is biphasic asymmetrical, pulses less than 500 microseconds and 10 hertz for 30 minutes. will be custom-made and the amplitude will be set as the sensory threshold. | Device | exercise therapy group, exercise-vagus stimulation group, vagus stimulation group |
Primary outcome
kinesiophobia assessment
Time frame: 6 months
Tampa Kinesiophobia Scale were used. The Tampa Kinesiophobia Scale (TKS) is one of them, and it's commonly used in the literature to assess kinesiophobia. It has 17 questions designed to assess fear of moving.
Pain Assessment
Time frame: 6 months
Pain Assessment Visual Analogue Scale (VAS) was used. On a 10-centimeter (cm) horizontal line, start 0 (no pain) and finish 10 (unbearable pain) are marked and the subjects were asked to place a mark on this horizontal line according to the degree of pain they felt. The point marked on the line was then measured with the help of a ruler and recorded as the VAS value in cm.
Depression Assessment
Time frame: 6 months
Depression Severity Assessment, The Beck Depression Inventory (BDI) was employed, which consists of 21 questions. The scale has a range of 0 to 84 points.
joint range of motion assessment
Time frame: 6 months
ROM will be evaluated with the goniometric measurement. This measurement method is an objective method used in the clinical evaluation of joint range of motion. Shoulder flexion, extension, abduction, adduction, external and internal rotation movements of the patients will be measured 3 times passively and actively with a universal goniometer.
functional limitation and disability status assessment
Time frame: 6 months
In our study, the Arm, Shoulder and Hand Problems Questionnaire (DASH), which is more preferred in the clinic, was used to evaluate upper extremity functional limitation and disability, which consists of 3 parts. The questionnaire consists of 30 questions that determine the function score in the first part; 21 questions about difficulty in activities of daily living, 5 questions about symptoms (pain, tingling, stiffness, activity-related pain), each of the remaining questions evaluates the patient's social function, work, sleep and self-confidence. The second part of the questionnaire is answered optionally and is a business model consisting of 4 questions. In the third part of the questionnaire, there is a section consisting of 4 elective questions that determine the disability level of patients who are sports-musician models, who want high performance, who are involved in sports or music.
Quality of Life assessment
Time frame: 6 months
In our study, the widely preferred SF-36 form, consisting of 36 items, was used to evaluate the quality of life in patients with musculoskeletal disorders, whose reliability and validity have been demonstrated by studies. The 36 items in this form cover 8 different health-related dimensions: physical, emotional and social function, physical role, mental health, general health, pain and vitality. For these dimensions, the scores of the items are coded and converted into a scale between 0-100 points. The scale that evaluates the scores of each subgroup between 0-100; 0 indicates "worst health" status, 100 indicates "best health" status.
Shoulder Pain and Disability Assessment
Time frame: 6 months
The Shoulder Pain and Disability Index, developed by Roach et al. in 1911, was used to assess the level of disability by questioning the level of limitation experienced by the participants during personal carrying, care and dressing activities, and to measure current shoulder pain and disability. The Spadi scale consists of 2 subscales of pain (5 questions) and disability (8 questions) and 13 subheadings. Pain and disability subscales are calculated between 0 (no pain) - 100 (worst pain imaginable). As a result of the survey, 3 different scores are obtained as Obstacle, Pain and Total score, each of which is scored separately. The answers given to the questions in the scale are calculated as the last percentile. The higher the total score on the scale, the higher the person's level of pain or disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagus nerve stimulation in people with Being in the 18-50 Age Population and Being Diagnosed With Frozen Shoulder by a Specialist Physician, run by Inonu University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact burak buğday, 1. (05357306877 ext. +90, burak.bugday@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kinesiophobia assessment (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022.