Adhesive Capsulitis of the ShouldertaVNS-ACNCT07711353
Transcutaneous Auricular Vagus Nerve Stimulation Added to Physiotherapy for Adhesive Capsulitis
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Conventional Physiotherapy in people with Adhesive Capsulitis of the Shoulder, run by Muhsin Doran at 1 site in Turkey (Türkiye).
Trial summary
This randomized, sham-controlled study will evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), when added to standard physiotherapy, improves pain, shoulder function, range of motion, and quality of life in adults with adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- What is being tested?
- Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 65 years.
- Clinical diagnosis of adhesive capsulitis confirmed by physical examination and, when clinically indicated, imaging.
- Shoulder pain and limitation of shoulder range of motion for at least 3 months.
- Provision of written informed consent.
- General health status sufficient to participate in standard physiotherapy and active or sham transcutaneous auricular vagus nerve stimulation.
- Ability to comply with the planned treatment sessions and outcome assessments.
Who cannot join
- Shoulder stiffness secondary to trauma, surgery, infection, or tumor.
- Rotator cuff tear, advanced glenohumeral osteoarthritis, or inflammatory rheumatic disease.
- Glucocorticoid injection into the affected shoulder within the previous 3 months.
- Surgical intervention involving the affected shoulder within the previous 6 months.
- Active infection or skin lesion in the shoulder region.
- Cervical radiculopathy, brachial plexopathy, stroke, or another neurological disorder affecting the upper extremity.
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- Presence of a cardiac pacemaker or another implanted electronic device.
- Pregnancy or breastfeeding.
- Serious systemic disease or cognitive impairment that may prevent compliance with the study protocol.
- Known intolerance or previous adverse reaction to transcutaneous electrical stimulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Liv hospital Vadistanbul
Istanbul, Istanbul, 34381
Muhsin Doran, MD, 05340807940, muhsin-doran@hotmail.com
About this study
Official title: Effect of Transcutaneous Auricular Vagus Nerve Stimulation Added to Standard Physiotherapy on Pain, Function, and Quality of Life in Patients With Shoulder Adhesive Capsulitis: A Randomized Controlled Trial
This randomized, sham-controlled study will evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), when added to standard physiotherapy, improves pain, shoulder function, range of motion, and quality of life in adults with adhesive capsulitis.
A total of 40 participants aged 18 to 65 years will be randomly assigned to one of two groups. Both groups will receive 15 sessions of standard physiotherapy over 3 weeks. In addition, one group will receive active taVNS for 30 minutes per day, while the other group will receive sham stimulation for the same duration and frequency. Assessments will be performed before treatment and after the 15th treatment session using pain, shoulder disability, quality-of-life, and shoulder range-of-motion measurements.
Read the detailed description
Adhesive capsulitis is a musculoskeletal condition characterized by shoulder pain and progressive restriction of active and passive range of motion. Although physiotherapy, therapeutic exercise, and manual therapy are commonly used, pain relief and functional recovery may be incomplete in some patients. Therefore, additional non-invasive treatment approaches that may enhance the effects of rehabilitation are clinically relevant.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that stimulates the auricular branch of the vagus nerve. It may influence pain modulation, autonomic nervous system regulation, and inflammatory pathways. Previous studies have reported potential benefits of auricular vagus nerve stimulation in several chronic pain conditions; however, evidence regarding its use in adhesive capsulitis remains limited.
The objective of this study is to determine whether active taVNS added to standard physiotherapy provides greater clinical improvement than sham taVNS added to the same physiotherapy program. The main hypothesis is that participants receiving active taVNS will demonstrate greater reductions in pain and shoulder-related disability after treatment. Secondary objectives are to evaluate changes in shoulder range of motion and health-related quality of life and to assess the tolerability of the intervention.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Being tested
- Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Conventional Physiotherapy, Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
Active transcutaneous auricular vagus nerve stimulation will be administered for 30 minutes per session during each of 15 treatment sessions over 3 weeks, in addition to standard physiotherapy. Electrical stimulation will be delivered transcutaneously through an auricular electrode to a vagally innervated region of the external ear. The physiotherapist administering the stimulation will be aware of group allocation, while participants and the outcomes assessor will remain blinded.
Conventional PhysiotherapyOther
Participants will receive 15 standard physiotherapy sessions over 3 weeks, with five sessions per week. The program will include pain-relieving physical therapy modalities, glenohumeral and scapulothoracic joint mobilization, passive and active-assisted range-of-motion exercises, capsular stretching, and progressive strengthening exercises for the rotator cuff and scapular stabilizing muscles. Treatment intensity and exercise progression will be individualized according to pain severity, irritability, and range-of-motion limitations. The same physiotherapy protocol will be administered to both study arms.
Sham Transcutaneous Auricular Vagus Nerve StimulationDevice
Sham transcutaneous auricular vagus nerve stimulation will be administered for 30 minutes per session during each of 15 treatment sessions over 3 weeks, in addition to standard physiotherapy. The sham procedure will follow the same session frequency and duration as the active intervention but will be applied according to a prespecified sham protocol that is not expected to produce therapeutic vagal stimulation. The physiotherapist administering the intervention will be aware of group allocation, while participants and the outcomes assessor will remain blinded.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physiotherapy Plus Active taVNS | Experimental | Participants receive 15 sessions of standard physiotherapy over 3 weeks. Active transcutaneous auricular vagus nerve stimulation is administered for 30 minutes during each treatment session in addition to the physiotherapy program. Receives: Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Conventional Physiotherapy |
| Standard Physiotherapy Plus Sham taVNS | Sham comparator | Participants receive 15 sessions of standard physiotherapy over 3 weeks. In addition, sham transcutaneous auricular vagus nerve stimulation is administered for 30 minutes with the same frequency and treatment schedule as the active stimulation. Receives: Other: Conventional Physiotherapy; Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI) Total Score
The Shoulder Pain and Disability Index (SPADI) is a 13-item patient-reported questionnaire consisting of a 5-item pain subscale and an 8-item disability subscale. The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. The primary outcome will be the change in the SPADI total score from baseline to the assessment performed after completion of the 15th treatment session.
Measured: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Secondary outcomes (3)
Change in Shoulder Pain Intensity Assessed With the Visual Analog Scale (VAS)
Shoulder pain intensity will be assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. The outcome will be calculated as the change in VAS score from baseline to the assessment performed after completion of the 15th treatment session.
Measured: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Change in Shoulder Flexion Range of Motion
Change in Shoulder Flexion Range of Motion Change in Shoulder Abduction Range of Motion Change in Shoulder Extension Range of Motion Change in Shoulder Internal Rotation Range of Motion Change in Shoulder External Rotation Range of Motion Change in Shoulder Horizontal External Rotation Range of Motion Change in Shoulder Horizontal Abduction Range of Motion Change in Shoulder Horizontal Adduction Range of Motion
Measured: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Change in Health-Related Quality of Life Assessed With the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. Changes in domain scores from baseline to the post-treatment assessment will be evaluated.
Measured: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start10 Jun 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies 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
- Participants are randomly assigned in a 1:1 ratio to two parallel groups: standard physiotherapy plus active transcutaneous auricular vagus nerve stimulation or standard physiotherapy plus sham stimulation. Participants remain in their assigned group throughout the 3-week intervention period, with no crossover between groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhsin Doran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhsin Doran, Liv Hospital Vadistanbul
- Investigators
- Muhsin Doran, Principal investigator, Liv Hospital Vadistanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711353
- Sponsor's protocol ID
- LIV-FTR-taVNS-AC-2026-01
- Acronym
- taVNS-AC
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant confidentiality, and no external IPD-sharing procedure has been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation Added to Standard Physiotherapy on Pain, Function, and Quality of Life in Patients With Shoulder Adhesive Capsulitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07711353
- Acronym / sponsor ID
- taVNS-AC / LIV-FTR-taVNS-AC-2026-01
- Conditions
- Adhesive Capsulitis of the Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Muhsin DoranUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 17 Jul 2026 (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.
This randomized, sham-controlled study will evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), when added to standard physiotherapy, improves pain, shoulder function, range of motion, and quality of life in adults with adhesive capsulitis.
A total of 40 participants aged 18 to 65 years will be randomly assigned to one of two groups. Both groups will receive 15 sessions of standard physiotherapy over 3 weeks. In addition, one group will receive active taVNS for 30 minutes per day, while the other group will receive sham stimulation for the same duration and frequency. Assessments will be performed before treatment and after the 15th treatment session using pain, shoulder disability, quality-of-life, and shoulder range-of-motion measurements.
Detailed description
Adhesive capsulitis is a musculoskeletal condition characterized by shoulder pain and progressive restriction of active and passive range of motion. Although physiotherapy, therapeutic exercise, and manual therapy are commonly used, pain relief and functional recovery may be incomplete in some patients. Therefore, additional non-invasive treatment approaches that may enhance the effects of rehabilitation are clinically relevant.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that stimulates the auricular branch of the vagus nerve. It may influence pain modulation, autonomic nervous system regulation, and inflammatory pathways. Previous studies have reported potential benefits of auricular vagus nerve stimulation in several chronic pain conditions; however, evidence regarding its use in adhesive capsulitis remains limited.
The objective of this study is to determine whether active taVNS added to standard physiotherapy provides greater clinical improvement than sham taVNS added to the same physiotherapy program. The main hypothesis is that participants receiving active taVNS will demonstrate greater reductions in pain and shoulder-related disability after treatment. Secondary objectives are to evaluate changes in shoulder range of motion and health-related quality of life and to assess the tolerability of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to two parallel groups: standard physiotherapy plus active transcutaneous auricular vagus nerve stimulation or standard physiotherapy plus sham stimulation. Participants remain in their assigned group throughout the 3-week intervention period, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Physiotherapy Plus Active taVNS | Experimental | Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Other: Conventional PhysiotherapyParticipants receive 15 sessions of standard physiotherapy over 3 weeks. Active transcutaneous auricular vagus nerve stimulation is administered for 30 minutes during each treatment session in addition to the physiotherapy program. |
| Standard Physiotherapy Plus Sham taVNS | Sham comparator | Other: Conventional Physiotherapy, Device: Sham Transcutaneous Auricular Vagus Nerve StimulationParticipants receive 15 sessions of standard physiotherapy over 3 weeks. In addition, sham transcutaneous auricular vagus nerve stimulation is administered for 30 minutes with the same frequency and treatment schedule as the active stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years.
- Clinical diagnosis of adhesive capsulitis confirmed by physical examination and, when clinically indicated, imaging.
- Shoulder pain and limitation of shoulder range of motion for at least 3 months.
- Provision of written informed consent.
- General health status sufficient to participate in standard physiotherapy and active or sham transcutaneous auricular vagus nerve stimulation.
Key exclusion criteria (10 listed)
- Shoulder stiffness secondary to trauma, surgery, infection, or tumor.
- Rotator cuff tear, advanced glenohumeral osteoarthritis, or inflammatory rheumatic disease.
- Glucocorticoid injection into the affected shoulder within the previous 3 months.
- Surgical intervention involving the affected shoulder within the previous 6 months.
- Active infection or skin lesion in the shoulder region.
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 |
|---|---|---|
| Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Active transcutaneous auricular vagus nerve stimulation will be administered for 30 minutes per session during each of 15 treatment sessions over 3 weeks, in addition to standard physiotherapy. Electrical stimulation will be delivered transcutaneously through an auricular electrode to a vagally innervated region of the external ear. The physiotherapist administering the stimulation will be aware of group allocation, while participants and the outcomes assessor will remain blinded. | Device | Standard Physiotherapy Plus Active taVNS |
| Conventional PhysiotherapyParticipants will receive 15 standard physiotherapy sessions over 3 weeks, with five sessions per week. The program will include pain-relieving physical therapy modalities, glenohumeral and scapulothoracic joint mobilization, passive and active-assisted range-of-motion exercises, capsular stretching, and progressive strengthening exercises for the rotator cuff and scapular stabilizing muscles. Treatment intensity and exercise progression will be individualized according to pain severity, irritability, and range-of-motion limitations. The same physiotherapy protocol will be administered to both study arms. | Other | Standard Physiotherapy Plus Active taVNS, Standard Physiotherapy Plus Sham taVNS |
| Sham Transcutaneous Auricular Vagus Nerve StimulationSham transcutaneous auricular vagus nerve stimulation will be administered for 30 minutes per session during each of 15 treatment sessions over 3 weeks, in addition to standard physiotherapy. The sham procedure will follow the same session frequency and duration as the active intervention but will be applied according to a prespecified sham protocol that is not expected to produce therapeutic vagal stimulation. The physiotherapist administering the intervention will be aware of group allocation, while participants and the outcomes assessor will remain blinded. | Device | Standard Physiotherapy Plus Sham taVNS |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI) Total Score
Time frame: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
The Shoulder Pain and Disability Index (SPADI) is a 13-item patient-reported questionnaire consisting of a 5-item pain subscale and an 8-item disability subscale. The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. The primary outcome will be the change in the SPADI total score from baseline to the assessment performed after completion of the 15th treatment session.
3 secondary outcomes
Change in Shoulder Pain Intensity Assessed With the Visual Analog Scale (VAS)
Time frame: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Change in Shoulder Flexion Range of Motion
Time frame: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Change in Health-Related Quality of Life Assessed With the 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant confidentiality, and no external IPD-sharing procedure has been established for this study.
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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.
Muhsin Doran principal investigator
Liv Hospital Vadistanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Conventional Physiotherapy in people with Adhesive Capsulitis of the Shoulder, run by Muhsin Doran 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhsin Doran, MD (05340807940, muhsin-doran@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Pain and Disability Index (SPADI) Total Score (time frame: Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks). 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 17 Jul 2026.