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Clinical Trials/NCT05214547
NCT05214547
Recruiting
Not Applicable

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

Bitlis Eren University1 site in 1 country20 target enrollmentFebruary 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adhesive Capsulitis
Sponsor
Bitlis Eren University
Enrollment
20
Locations
1
Primary Endpoint
Change from Baseline Shoulder Pain at 4 weeks
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2022
End Date
June 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bitlis Eren University
Responsible Party
Principal Investigator
Principal Investigator

Tülay Çevik Saldıran

Associate Professor

Bitlis Eren University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from Baseline Shoulder Pain at 4 weeks

Time Frame: At 4 week

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.

Change from 4 weeks Shoulder Pain at 6 weeks

Time Frame: At 6 week

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.

Secondary Outcomes

  • Change from Baseline Range of Motion of Shoulder Joint at 4 weeks(At 4 weeks)
  • Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks(At 6 weeks)
  • Change from 4 weeks Shoulder Function at 6 weeks(At 6 weeks)
  • Change from Baseline Shoulder Function at 4 weeks(At 4 weeks)

Study Sites (1)

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