Transcutaneous Auricular Vagus Nerve Stimulation Added to Physiotherapy for Adhesive Capsulitis

NCT07711353 | Recruiting

• 1 other identifier: LIV-FTR-taVNS-AC-2026-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adhesive Capsulitis of the Shoulder

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks

• Change in Shoulder Flexion Range of Motion

  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)

  Baseline and immediately after completion of the 15th treatment session, approximately 3 weeks

Study Arms (2)

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.

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.

Other: Conventional Physiotherapy; Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

Conventional Physiotherapy OTHER

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.

Standard Physiotherapy Plus Active taVNS; Standard Physiotherapy Plus Sham taVNS

Sham Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

Standard Physiotherapy Plus Sham taVNS

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.

Standard Physiotherapy Plus Active taVNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Muhsin Doran: lead

Study Sites (1)

Liv hospital Vadistanbul

Istanbul, Istanbul, 34381, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Muhsin Doran

  Liv Hospital Vadistanbul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhsin Doran, MD

CONTACT

05340807940; muhsin-doran@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the outcomes assessor are blinded to group allocation. The physiotherapist administering active or sham transcutaneous auricular vagus nerve stimulation is aware of the assigned intervention and is not involved in outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)