Effect of Vibrotactile Stimulation in Lateral Epicondylitis

NCT06674668 | Recruiting

• 1 other identifier: İK-2023-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

It is aimed to investigate the immediate effect of vibrotactile stimulation on pain, sense and functionality in patients with lateral epicondylitis.

Conditions

Lateral Epicondylitis; Vibration Therapy; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• Pain Severity

  A 10 cm visual analog scale (VAS) was used to assess pain intensity. A horizontal 10 cm ruler was used (0 = no pain and 10 = worst pain).

  from pre-interventional time to post-interventional about 1st hour

• Pressure pain threshold

  The J tech brand algometer device will be used for the pressure pain threshold measurement. The trigger points will be found by palpation. The person will be told that the device will apply pressure to the trigger point and that they will give the command "stop" when they first feel the pain.

  from pre-interventional time to post-interventional about 1st hour

• Joint position sense

  Elbow joint position sense will be measured with an inclinometer for 45 and 60 degree flexion target angle. The elbow will be brought to the target angle and they will be asked to memorize the movement by holding it for 10 seconds. Then, they will be asked to bring the target force they learned themselves. The absolute value of the difference between the target value and the last measurements will be taken as the error score.

  from pre-interventional time to post-interventional about 1st hour

Secondary Outcomes (3)

• Hand grip sensitivity level

  from pre-interventional time to post-interventional about 1st hour

• Grip Strength

  from pre-interventional time to post-interventional about 1st hour

• Functional assessment

  2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention includes traditional physiotherapy and vibrotactile device use.

Other: Vibrotactile stimulation

Control group

ACTIVE COMPARATOR

For traditional physiotherapy, passive stretching exercises, radial head mobilization and deep friction massage will be applied to the affected extremity.

Other: Traditional physiotherapy

Interventions

Vibrotactile stimulation OTHER

The intervention includes traditional physiotherapy and 20 minutes of vibrotactile device use. As traditional physiotherapy, 30 seconds of 8 repetitions of passive wrist stretching exercises, radial head mobilization and deep friction massage will be applied to the affected extremity. Afterwards, the Intellinetix Elbow Wearable Vibration Device providing vibration will be worn on the affected tissue. The patient will remain in a comfortable position on the treatment table with the affected extremity for 20 minutes (10 minutes × 2).

Intervention group

Traditional physiotherapy OTHER

For traditional physiotherapy, passive stretching exercises, radial head mobilization and deep friction massage will be applied to the affected extremity. Stretching exercises will be performed on the wrist flexor and extensor muscles for 30 seconds and 8 repetitions. Mill's manipulation, described by James Cyriax, will be applied once for radial head mobilization. The treatment will be completed with a 5-minute deep friction massage, affecting the wrist extensor muscle tendons and their ending points.

Control group

Eligibility Criteria

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

You may qualify if:

• Being between 18-65 years of age
• Patients diagnosed with lateral epicondylitis

You may not qualify if:

• Having had elbow surgery
• Having a history of congenital or acquired orthopedic, neurological, or rheumatological conditions affecting the upper limb
• Having received any conservative treatment for the diagnosis of lateral epicondylitis

Sponsors & Collaborators

• Medipol University: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• Istanbul Kültür University: collaborator

Study Sites (1)

Istanbul Kultur University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Central Study Contacts

Imge NAS

CONTACT

+902124984141; i.nas@iku.edu.tr

Study Design

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

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 5, 2024
• Study Start: June 14, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)