Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

NCT07368751 | Recruiting

• 1 other identifier: IUC-FTR-SA-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Frozen Shoulder

Keywords

Frozen Shoulder; Vagus Nerve Stimulation; Exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  At weeks 6 and 12

Study Arms (2)

transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises

EXPERIMENTAL

the interventional group will receive active tVNS plus exercise therapy including traditional exercises and home exercises.

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.

Other: Sham controlled tVNS plus exercises

Interventions

Active tVNS plus exercises OTHER

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.

transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises

Sham controlled tVNS plus exercises OTHER

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.

Sham controlled tVNS plus exercises

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Salam Alruz, Msc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salam Alruz, MSc

CONTACT

+90 5510805265; salamalruz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 27, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)