Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment
ConditionFrozen Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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°.
Disqualifiers
Passive joint range of motion within normal limits
External rotation range of motion <30°
Radiographic evidence of glenohumeral arthritis
Presence of inflammatory joint disease
Trial design
Design model
Parallel
Treatments tested in this trial
Active tVNS plus exercises
Other interventionThis 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.
Sham controlled tVNS plus exercises
Other interventionThis 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: transcutaneous Vagus Nerve Stimulation (tVNS) plus exercisesExperimental treatment 1 intervention
Group B: Sham controlled tVNS plus exercisesSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline in SPADI score at weeks 6 and 122
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.
Time frame
Change from baseline in NPRS score at week 6 and week 12Secondary outcomes
1
Change from baseline in Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) score at week 6 and week 12
QuickDASH is a patient-reported outcome measure and will be used to assess upper extremity function and symptoms. The total score ranges from 0 to 100, with higher scores indicating greater functional disability.
Time frame
Change from baseline in QuickDASH score at weeks 6 and 122
Change from baseline in Pain Catastrophizing Scale (PCS) score at week 6 and week 12
The Pain Catastrophizing Scale (PCS) will be used to assess rumination, magnification, and helplessness related to pain. The scale yields a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Time frame
Change from baseline in PCS score at weeks 6 and 123
change from baseline in the Glenohumeral Joint Range of Motion at week 6 and week 12
Glenohumeral joint range of motion will be assessed using a universal goniometer, a widely used and reliable method for measuring shoulder joint mobility.
Time frame
Change from baseline in range of motion at weeks 6 and 124
Change from baseline in Pain Self-Efficacy Questionnaire (PSEQ) score at week 6 and week 12
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report questionnaire designed to assess an individual's confidence in performing activities despite pain. Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.
Time frame
Change from baseline in PSEQ score at weeks 6 and 12Sponsors and contacts
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Source ClinicalTrials.gov