Effectiveness of Focal Vibration in Shoulder Pathology

Not Applicable

Recruiting

• Conditions: Adhesive Capsulitis; Shoulder
• Interventions: Device: Focal VibrationTherapy

• Registration Number: NCT05214547
• Lead Sponsor: Bitlis Eren University

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.

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-02-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Focal VibrationTherapy	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.
Experimental Group	Focal VibrationTherapy	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Shoulder Pain at 4 weeks	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	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 Outcome Measures

Name	Time	Method
Change from Baseline Range of Motion of Shoulder Joint at 4 weeks	At 4 weeks	The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.
Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks	At 6 weeks	The 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 weeks	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.
Change from Baseline Shoulder Function at 4 weeks	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.

Trial Locations

Locations (1)

Bitlis Eren University; 🇹🇷 Bitlis, Turkey