Effectiveness of Focal Vibration in Shoulder Pathology

NCT05214547 | Recruiting

• 1 other identifier: BEU_FV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis; Shoulder

Keywords

Pain, Shoulder; Vibration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 Baseline Shoulder Function at 4 weeks

  At 4 weeks

• Change from 4 weeks Shoulder Function at 6 weeks

  At 6 weeks

Other Outcomes (1)

• Change from baseline Shoulder Muscle Tone at 6 weeks

  At 6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Focal VibrationTherapy 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; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Eren University

Bitlis, 13100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tülay Çevik Saldıran, Ph.D.

  Bitlis Eren University

  STUDY DIRECTOR

Central Study Contacts

Tülay Çevik Saldıran, Ph.D.

CONTACT

5057367863; tlyfztcvk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 28, 2022
• Study Start: February 25, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 25, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)