Effectiveness of Focal Vibration in Shoulder Pathology

NCT ID: NCT05214547

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2024-06-25

Brief Summary

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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

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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.

Conditions

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Adhesive Capsulitis Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Focal VibrationTherapy

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Focal VibrationTherapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Tülay Çevik Saldıran

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tülay Çevik Saldıran, Ph.D.

Role: STUDY_DIRECTOR

Bitlis Eren University

Locations

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Bitlis Eren University

Bitlis, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tülay Çevik Saldıran, Ph.D.

Role: CONTACT

5057367863 ext. +90

Facility Contacts

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Tülay Çevik Saldıran, Ph.D

Role: primary

05057367863 ext. +90

Other Identifiers

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BEU_FV

Identifier Type: -

Identifier Source: org_study_id

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