Actively Recruiting
Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
Led by Istanbul University - Cerrahpasa · Updated on 2026-02-04
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 65 years
- Less than 50% range of motion compared with the opposite 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
- Increased limitation of shoulder external and internal rotation during abduction from 45° to 90°
- Shoulder pain lasting at least 3 months during daily activities
You will not qualify if you...
- Passive shoulder joint range of motion within normal limits
- External rotation range of motion less than 30°
- Radiographic evidence of glenohumeral arthritis
- Presence of inflammatory joint disease
- Previous treatment for the current shoulder complaint, including physiotherapy, intra-articular injections, or surgery
- Pain intensity less than 3 on the Numerical Pain Rating Scale
- Presence of neurological deficits, cardiac disease, neuropathic disorders, or pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Salam Alruz, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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