Effect of Vibrotactile Stimulation in Lateral Epicondylitis

Immediate Effect of Wearable Vibrotactile Stimulation on Pain and Sense in Patients with Lateral Epicondylitis

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

Study Overview

• Status: Recruiting
• Conditions: Lateral Epicondylitis; Physiotherapy; Vibration Therapy
• Intervention / Treatment: Other: Vibrotactile stimulation; Other: Traditional physiotherapy

Detailed Description

Lateral epicondylitis (LE) is a chronic degenerative disease of the attachment site of the extensor tendons to the lateral epicondyle of the humerus. The annual incidence is 1-3% of the world population and is most common between the ages of 30 and 60. Although LE is often called "tennis elbow," a small percentage of patients play tennis. The etiology of the disease is multifactorial, and it is generally thought to be caused by repetitive wrist activities that include gripping, wrist extension, and supination. Most patients recover spontaneously within 1-2 years. However, loss of work capacity is quite common in jobs that require the use of the upper extremity.

The pathophysiology of the disease is currently explained by degenerative mechanisms instead of the idea of inflammatory infiltration. Microtears and tendinosis caused by increased force on the tendon are supported by ultrasonographic examinations. However, currently, pain and functional disability in daily life are explained by sensory changes such as pain pressure threshold, impaired vibration perception and joint position sense rather than tendon structure changes. Clinically, lateral elbow pain results in decreased grip strength and proprioception, and consequently loss of function.

In LE management, the aim is to relieve pain, minimize excessive loads on the arm and restore the patient to optimal daily life activities and former functionality.

While there is insufficient evidence on the effectiveness of surgical interventions in treatment, nonoperative methods are frequently preferred. Patient education, use of splints, medical treatments, biological treatments, physical agents, taping, and manual therapy approaches are frequently used. While conservative treatments remain up-to-date for pain and disability, the most appropriate treatment strategy is controversial.

The use of technology in physiotherapy has been increasing in recent years. In addition to motor movement, the development of sensory skills is also emphasized. On the other hand, vibrotactile stimulation has been reported to contribute to the sensory processing mechanism by causing different activity levels in the brain. There are no studies in the literature investigating the effects of wearable vibration technology on sensory parameters in LE patients. The aim of this study is to investigate the effects of wearable vibrotactile application on pain, sensation and upper extremity function compared to traditional physiotherapy in patients with LE.

Patients diagnosed with LE will be included in the study. Participants will be randomized into two groups. Patients in both groups will receive one session of conventional physiotherapy on the affected extremity. In addition to the intervention group, the use of a wearable vibrotactile device will be provided. Immediate effects will be evaluated before and after the application in both groups.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imge NAS; Phone Number: +902124984141; Email: i.nas@iku.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul Kultur University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention includes traditional physiotherapy and vibrotactile device use.	Other: Vibrotactile stimulation; 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).
Active Comparator: Control group; For traditional physiotherapy, passive stretching exercises, radial head mobilization and deep friction massage will be applied to the affected extremity.	Other: Traditional physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip sensitivity level	Pneumatic dynamometer will be used for measurement. The individual's maximum grip strength will be measured and half will be taken to determine the target strength. First, the target strength measurement will be made, then the target measurement will be asked to repeat it without seeing the target measurement value. The absolute value of the difference between the targeted value and the measurements will be calculated and recorded as an error score.	from pre-interventional time to post-interventional about 1st hour
Grip Strength	Takei Hand Grip Dynamometer will be used to assess painless grip strength. Subjects will be instructed to increase their grip strength and stop if they feel pain or discomfort. Painless grip strength will be measured 3 times with 30 seconds between measurements and an average score will be obtained.	from pre-interventional time to post-interventional about 1st hour
Functional assessment	The Turkish version of the Disability Score for the Arm, Shoulder and Hand (DASH) will be used to assess upper extremity physical function. The questionnaire consists of 30 questions. Scores range from 0 to 100. Higher scores indicate lower functionality.	2 weeks

Collaborators and Investigators

• Sponsor: Medipol University
• Collaborators: Istanbul Kültür University; Scientific and Technological Research Council of Turkey (TÜBİTAK)

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: İK-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No