Effect of Vibrotactile Stimulation in Lateral Epicondylitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being between 18-65 years of age

Patients diagnosed with lateral epicondylitis

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibrotactile stimulation

    Other intervention

    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).

  • Traditional physiotherapy

    Other intervention

    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.

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
from pre-interventional time to post-interventional about 1st hour
2

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.

Time frame
from pre-interventional time to post-interventional about 1st hour
3

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.

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

Secondary outcomes

1

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.

Time frame
from pre-interventional time to post-interventional about 1st hour
2

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.

Time frame
from pre-interventional time to post-interventional about 1st hour
3

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.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Istanbul Kültür University

Sponsor institution

The Scientific and Technological Research Council of Turkey

Collaborator

Istanbul Kültür University

Collaborator