Effectiveness of Focal Vibration in Shoulder Pathology

Adhesive Capsulitis Clinical Trial

— FVinAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214547
• Other study ID #: BEU_FV
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: June 25, 2024

Study information

• Verified date: June 2024
• Source: Bitlis Eren University
• Contact: Tülay Çevik Saldiran, Ph.D.
• Phone: 5057367863
• Email: tlyfztcvk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 25, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Shoulder

Intervention

Device:
• Focal 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.

Locations

Country	Name	City	State
Turkey	Bitlis Eren University	Bitlis

Sponsors (1)

Lead Sponsor	Collaborator
Bitlis Eren University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Shoulder Muscle Tone at 6 weeks	The 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.	At 6 weeks
Primary	Change from Baseline Shoulder Pain at 4 weeks	Evaluation 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.	At 4 week
Primary	Change from 4 weeks Shoulder Pain at 6 weeks	Evaluation 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.	At 6 week
Secondary	Change from Baseline Range of Motion of Shoulder Joint at 4 weeks	The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.	At 4 weeks
Secondary	Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks	The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.	At 6 weeks
Secondary	Change from Baseline Shoulder Function at 4 weeks	Function 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.	At 4 weeks
Secondary	Change from 4 weeks Shoulder Function at 6 weeks	Function 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.	At 6 weeks