Clinical trial NCT06674668: Effect of Vibrotactile Stimulation in Lateral Epicondylitis
Official title: Immediate Effect of Wearable Vibrotactile Stimulation on Pain and Sense in Patients with Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Vibration Therapy
Physiotherapy
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Istanbul Kültür University
First posted: 2024-11-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity
timeFrame: from pre-interventional time to post-interventional about 1st hour
measure: Pressure pain threshold
timeFrame: from pre-interventional time to post-interventional about 1st hour
measure: Joint position sense
timeFrame: from pre-interventional time to post-interventional about 1st hour
Secondary outcomes:
measure: Hand grip sensitivity level
timeFrame: from pre-interventional time to post-interventional about 1st hour
measure: Grip Strength
timeFrame: from pre-interventional time to post-interventional about 1st hour
measure: Functional assessment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kultur University
Study officials:
References: