Frozen ShoulderNCT07368751
Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
A study testing Active tVNS plus exercises in people with Frozen Shoulder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Active tVNS plus exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 1 Mar 2027
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years.
- Less than 50% range of motion compared with the contralateral shoulder in at least one movement (external rotation, abduction, flexion, or internal rotation).
- More than 25% loss of range of motion in at least two movement planes compared with the unaffected shoulder.
- Increasing limitation of glenohumeral external and internal rotation during abduction from 45° to 90°.
- Shoulder pain lasting at least 3 months during activities of daily living.
Who cannot join
- Passive joint range of motion within normal limits
- External rotation range of motion <30°
- Radiographic evidence of glenohumeral arthritis
- Presence of inflammatory joint disease
- Previous treatment related to the current shoulder complaint (physiotherapy and rehabilitation, intra-articular injection, or surgery)
- Pain intensity <3 according to the Numerical Pain Rating Scale (NPRS)
- Presence of neurological deficits, cardiac disease, neuropathic disorders, or pregnancy
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
Istanbul University-Cerrahpaşa
Istanbul
Salam Alruz, Msc, +90 5510805265, salamalruz@gmail.com
Derya Çelik
About this study
Official title: Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder.
The main questions this study aims to answer are:
Read more
Does adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and shoulder range of motion? Does adding tVNS to exercise improve psychological factors ? Does adding tVNS to exercise improve patient satisfaction?
Researchers will compare the effect of active tVNS added to exercise with sham-controlled tVNS added to exercise to determine whether adding tVNS provides additional benefits in the management of frozen shoulder.
Participants will:
Receive active tVNS plus exercise therapy or sham-controlled tVNS plus exercise therapy.
Attend supervised rehabilitation sessions 3 times per week for 6 weeks. Perform a home exercise program as instructed by the study physiotherapist.
Read the detailed description
This is a randomized, double-blind (participants and outcome assessors), sham-controlled study. Participants will be recruited from a university hospital. Volunteers diagnosed with frozen shoulder who meet the inclusion criteria and are referred by an orthopedics and traumatology specialist will be included.
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Participants who provide written informed consent and meet the inclusion criteria will be randomized in a 1:1 ratio to either exercise therapy combined with active transcutaneous Vagus Nerve Stimulation (tVNS) or exercise therapy combined with sham-controlled tVNS.
- Conditions
- Frozen Shoulder
- Being tested
- Active tVNS plus exercises, Sham controlled tVNS plus exercises
- Keywords
- Frozen Shoulder, Vagus Nerve Stimulation, Exercise
- Medical subject headings
- Bursitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tVNS plus exercisesOther
This program will be performed 3 times per week for 6 weeks. Each session will include 30 minutes of tVNS. Stimulation will be delivered to the auricular branch of the vagus nerve using a non-invasive transcutaneous device. Electrodes will be placed on the tragus and concha regions of the ear. in addition to traditional exercises including mobilization, ROM exercises, stretching and strengthening exercises.
Sham controlled tVNS plus exercisesOther
This program will be performed three times per week for six weeks. In each session, 30 minutes of sham tVNS will be applied, during which the device will remain inactive, in addition to traditional exercise therapy including joint mobilization, range of motion exercises, stretching, and strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises | Experimental | the interventional group will receive active tVNS plus exercise therapy including traditional exercises and home exercises. Receives: Other: Active tVNS plus exercises |
| Sham controlled tVNS plus exercises | Sham comparator | the control group will receive Sham-controlled tVNS plus exercise therapy including traditional exercises and home exercises. Receives: Other: Sham controlled tVNS plus exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12.
The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability levels in patients. SPADI consists of 13 items and includes two subscales: pain and disability. The pain subscale consists of 5 items while the disability subscale consists of 8 items. Both subscale scores and the total score are calculated on a 0-100 scale, with higher scores indicating greater pain and disability.
Measured: Change from baseline in SPADI score at weeks 6 and 12
Change from baseline of Numerical Rating Pain Scale (NPRS) at week 6 and week 12
Pain intensity will be assessed using the Numerical Rating Pain Scale (NPRS). Participants will be asked to rate the intensity of their shoulder pain on a scale from 0 to 10, with higher scores indicating greater pain.
Measured: Change from baseline in NPRS score at week 6 and week 12
Secondary outcomes (5)
Change from baseline in Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) score at week 6 and week 12
QuickDASH is a patient-reported outcome measure and will be used to assess upper extremity function and symptoms. The total score ranges from 0 to 100, with higher scores indicating greater functional disability.
Measured: Change from baseline in QuickDASH score at weeks 6 and 12
Change from baseline in Pain Catastrophizing Scale (PCS) score at week 6 and week 12
The Pain Catastrophizing Scale (PCS) will be used to assess rumination, magnification, and helplessness related to pain. The scale yields a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Measured: Change from baseline in PCS score at weeks 6 and 12
change from baseline in the Glenohumeral Joint Range of Motion at week 6 and week 12
Glenohumeral joint range of motion will be assessed using a universal goniometer, a widely used and reliable method for measuring shoulder joint mobility.
Measured: Change from baseline in range of motion at weeks 6 and 12
Change from baseline in Pain Self-Efficacy Questionnaire (PSEQ) score at week 6 and week 12
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report questionnaire designed to assess an individual's confidence in performing activities despite pain. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.
Measured: Change from baseline in PSEQ score at weeks 6 and 12
Treatment satisfaction assessed with the Global Rating of Change (GRC) Scale at weeks 6 and 12
GRC scale is designed to measure a patient's perceived improvement or deterioration over time to determine the effect of an intervention. A 5-point scale ranging from -2 to +2 will be used (-2 = much worse, -1 = worse, 0 = no change, +1 = better, +2 = much better).
Measured: At weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start2 Feb 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salam Alruz, Istanbul University - Cerrahpasa
- Investigators
- Salam Alruz, Msc, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368751
- Sponsor's protocol ID
- IUC-FTR-SA-01
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07368751
- Acronym / sponsor ID
- IUC-FTR-SA-01
- Conditions
- Frozen Shoulder
- Keywords
- Frozen Shoulder, Vagus Nerve Stimulation, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Jan 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.
The goal of this clinical trial is to learn if the addition of transcutaneous vagus nerve stimulation (tVNS) to exercise is effective in improving pain, shoulder function, shoulder range of motion, and psychological factors in adults with frozen shoulder.
The main questions this study aims to answer are:
Does adding tVNS to exercise reduce shoulder pain ? Does adding tVNS to exercise improve shoulder function and shoulder range of motion? Does adding tVNS to exercise improve psychological factors ? Does adding tVNS to exercise improve patient satisfaction?
Researchers will compare the effect of active tVNS added to exercise with sham-controlled tVNS added to exercise to determine whether adding tVNS provides additional benefits in the management of frozen shoulder.
Participants will:
Receive active tVNS plus exercise therapy or sham-controlled tVNS plus exercise therapy.
Attend supervised rehabilitation sessions 3 times per week for 6 weeks. Perform a home exercise program as instructed by the study physiotherapist.
Detailed description
This is a randomized, double-blind (participants and outcome assessors), sham-controlled study. Participants will be recruited from a university hospital. Volunteers diagnosed with frozen shoulder who meet the inclusion criteria and are referred by an orthopedics and traumatology specialist will be included.
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Participants who provide written informed consent and meet the inclusion criteria will be randomized in a 1:1 ratio to either exercise therapy combined with active transcutaneous Vagus Nerve Stimulation (tVNS) or exercise therapy combined with sham-controlled tVNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises | Experimental | Other: Active tVNS plus exercisesthe interventional group will receive active tVNS plus exercise therapy including traditional exercises and home exercises. |
| Sham controlled tVNS plus exercises | Sham comparator | Other: Sham controlled tVNS plus exercisesthe control group will receive Sham-controlled tVNS plus exercise therapy including traditional exercises and home exercises. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 65 years.
- Less than 50% range of motion compared with the contralateral shoulder in at least one movement (external rotation, abduction, flexion, or internal rotation).
- More than 25% loss of range of motion in at least two movement planes compared with the unaffected shoulder.
- Increasing limitation of glenohumeral external and internal rotation during abduction from 45° to 90°.
- Shoulder pain lasting at least 3 months during activities of daily living.
Key exclusion criteria (7 listed)
- Passive joint range of motion within normal limits
- External rotation range of motion <30°
- Radiographic evidence of glenohumeral arthritis
- Presence of inflammatory joint disease
- Previous treatment related to the current shoulder complaint (physiotherapy and rehabilitation, intra-articular injection, or surgery)
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 tVNS plus exercisesThis program will be performed 3 times per week for 6 weeks. Each session will include 30 minutes of tVNS. Stimulation will be delivered to the auricular branch of the vagus nerve using a non-invasive transcutaneous device. Electrodes will be placed on the tragus and concha regions of the ear. in addition to traditional exercises including mobilization, ROM exercises, stretching and strengthening exercises. | Other | transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises |
| Sham controlled tVNS plus exercisesThis program will be performed three times per week for six weeks. In each session, 30 minutes of sham tVNS will be applied, during which the device will remain inactive, in addition to traditional exercise therapy including joint mobilization, range of motion exercises, stretching, and strengthening exercises. | Other | Sham controlled tVNS plus exercises |
Primary outcome
Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12.
Time frame: Change from baseline in SPADI score at weeks 6 and 12
The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability levels in patients. SPADI consists of 13 items and includes two subscales: pain and disability. The pain subscale consists of 5 items while the disability subscale consists of 8 items. Both subscale scores and the total score are calculated on a 0-100 scale, with higher scores indicating greater pain and disability.
Change from baseline of Numerical Rating Pain Scale (NPRS) at week 6 and week 12
Time frame: Change from baseline in NPRS score at week 6 and week 12
Pain intensity will be assessed using the Numerical Rating Pain Scale (NPRS). Participants will be asked to rate the intensity of their shoulder pain on a scale from 0 to 10, with higher scores indicating greater pain.
5 secondary outcomes
Change from baseline in Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) score at week 6 and week 12
Time frame: Change from baseline in QuickDASH score at weeks 6 and 12
Change from baseline in Pain Catastrophizing Scale (PCS) score at week 6 and week 12
Time frame: Change from baseline in PCS score at weeks 6 and 12
change from baseline in the Glenohumeral Joint Range of Motion at week 6 and week 12
Time frame: Change from baseline in range of motion at weeks 6 and 12
Change from baseline in Pain Self-Efficacy Questionnaire (PSEQ) score at week 6 and week 12
Time frame: Change from baseline in PSEQ score at weeks 6 and 12
Treatment satisfaction assessed with the Global Rating of Change (GRC) Scale at weeks 6 and 12
Time frame: At weeks 6 and 12
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 4 Feb 2026.
- 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.
Salam Alruz, Msc principal investigator
Istanbul University - Cerrahpasa
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 tVNS plus exercises in people with Frozen Shoulder, run by Istanbul University - Cerrahpasa 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 5 inclusion and 7 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 4 Feb 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 Salam Alruz, MSc (+90 5510805265, salamalruz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Shoulder Pain and Disability Index (SPADI) at weeks 6 and 12. (time frame: Change from baseline in SPADI score at weeks 6 and 12). The study lists 2 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 4 Feb 2026.