Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

Official title

Clinical Effects of Transcutaneous Vagus Nerve Stimulation in the Treatment of Frozen Shoulder: A Randomized Controlled Trial

Overview

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.

Interventions

• Other Active tVNS plus exercises
  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.
• Other Sham controlled tVNS plus exercises
  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.

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul University-Cerrahpaşa — Istanbul

Identifiers

NCT: NCT07368751 · IUC-FTR-SA-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗