Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

Istanbul University - Cerrahpasa

Status: Enrolling

Conditions: Frozen Shoulder

Treatments: Other: Active tVNS plus exercises; Other: Sham controlled tVNS plus exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07368751

IUC-FTR-SA-01

Details and patient eligibility

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

transcutaneous Vagus Nerve Stimulation (tVNS) plus exercises

Experimental group

Description:

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

Treatment:

Other: Active tVNS plus exercises

Sham controlled tVNS plus exercises

Sham Comparator group

Description:

the control group will receive Sham-controlled tVNS plus exercise therapy including traditional exercises and home exercises.

Treatment:

Other: Sham controlled tVNS plus exercises