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Effectiveness of Focal Vibration in Shoulder Pathology

Focal Vibration Therapy Effectiveness in the Treatment of Patients With Adhesive Capsulitis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05214547
Acronym
FVinAC
Enrollment
20
Registered
2022-01-28
Start date
2022-02-25
Completion date
2024-06-25
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis, Shoulder

Keywords

Pain, Shoulder, Vibration

Brief summary

We hypothesize that focal vibration therapy will reduce pain, increase the mobilization of the glenohumeral joint, and will improve functionality in patients with adhesive capsulitis.

Detailed description

The underlying mechanism of focal vibration therapy in individuals with adhesive capsulitis still remains unclear. Considering the physiological mechanism of focal vibration therapy, the effect of focal vibration therapy on pain, function, and resting muscle tone in patients with adhesive capsulitis will be evaluated. There are no studies examining the effect of focal vibration therapy on shoulder muscle tone in individuals with adhesive capsulitis.

Interventions

DEVICEFocal VibrationTherapy

Myovolt delivers oscillatory mechanical vibration of focussed frequency and low amplitude to stimulate physiological benefits in soft tissues. Myovolt is non-aggressive and gentle to the body so can be safely targeted. Digitally tuned to transmit a discrete vibration frequency range between 30 - 100Hz for effective neuromuscular stimulation.

Sponsors

Bitlis Eren University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged \> 18 years * Unilateral adhesive capsulitis of the shoulder * The symptom duration \> 3 months * Shoulder pain * The limited glenohumeral joint active range of motion of greater than 50% in at least three specific movements among abduction, flexion, internal rotation, and external rotation

Exclusion criteria

* Previous shoulder surgeries * Massive, minor, and major rotator cuff tears * Pain and muscle strength loss due to neurological causes * History or presence of malignancy * Osteoporosis * Diabetes

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Shoulder Pain at 4 weeksAt 4 weekEvaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the no pain on the far left and the most intense pain imaginable on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.
Change from 4 weeks Shoulder Pain at 6 weeksAt 6 weekEvaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the no pain on the far left and the most intense pain imaginable on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.

Secondary

MeasureTime frameDescription
Change from Baseline Shoulder Function at 4 weeksAt 4 weeksFunction was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, higher score indicating greater impairment or disability.
Change from Baseline Range of Motion of Shoulder Joint at 4 weeksAt 4 weeksThe joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.
Change from 4 weeks Shoulder Function at 6 weeksAt 6 weeksFunction was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item sub-scale that measures pain and an 8-item sub-scale that measures disability. Each sub-scale is summed and transformed to a score out of 100. A mean is taken of the two sub-scales to give a total score out of 100, higher score indicating greater impairment or disability.
Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeksAt 6 weeksThe joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.

Other

MeasureTime frameDescription
Change from baseline Shoulder Muscle Tone at 6 weeksAt 6 weeksThe muscle tone which is a biomechanical property of the shoulder muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.

Countries

Turkey (Türkiye)

Contacts

Primary ContactTülay Çevik Saldıran, Ph.D.
tlyfztcvk@gmail.com5057367863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026