Effectiveness of Focal Vibration in Shoulder Pathology (FVinAC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis; Shoulder
• Intervention / Treatment: Device: Focal VibrationTherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tülay Çevik Saldıran, Ph.D.; Phone Number: +90 5057367863; Email: tlyfztcvk@gmail.com

Study Locations

• Turkey
  • Bitlis, Turkey, 13100
    • Recruiting
    • Bitlis Eren University
    • Contact: Tülay Çevik Saldıran, Ph.D; Phone Number: +90 05057367863; Email: tlyfztcvk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Focal Vibration Group Training with Focal Vibration on the deltoid, trapezius, and biceps muscles with an amplitude of 1.2 mm. Time of training 20-25 min. The configuration of the vibration program will be in an automatic mode of 10 seconds of vibration and 3 seconds of rest to avoid the coupling of the mechanoreceptors. Patients will be treated with FV for three consecutive days: each session consisted of three sessions of 10 minutes each, interspersed with one minute of rest. A vibration frequency of 40 Hz to 100 Hz has been applied, according to the literature. The group also received the Traditional Training.	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.
Active Comparator: Control Group; Traditional Training Warm up, grade 1 and 2 mobilization and stretching exercises, strength training, range of motion exercises, and coordination training. The home exercises program is programmed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bitlis Eren University
• Collaborators: Okan University; Medipol University
• Investigators: Study Director: Tülay Çevik Saldıran, Ph.D., Bitlis Eren University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 25, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Vibration; Pain, Shoulder
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: BEU_FV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No