Lateral EpicondylitisNCT06674668
Effect of Vibrotactile Stimulation in Lateral Epicondylitis
A study testing Vibrotactile stimulation and Traditional physiotherapy in people with Lateral Epicondylitis and Vibration Therapy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to investigate the immediate effect of vibrotactile stimulation on pain, sense and functionality in patients with lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Vibration Therapy, Physiotherapy
- What is being tested?
- Vibrotactile stimulation and Traditional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18-65 years of age
- Patients diagnosed with lateral epicondylitis
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Kultur University
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Lateral Epicondylitis, Vibration Therapy, Physiotherapy
- Being tested
- Vibrotactile stimulation, Traditional physiotherapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile stimulationOther
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 physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention includes traditional physiotherapy and vibrotactile device use. Receives: 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. Receives: Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: from pre-interventional time to post-interventional about 1st hour
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start14 Jun 2023
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Istanbul Kültür University
- Responsible party
- Principal investigator, Imge NAS, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674668
- Sponsor's protocol ID
- İK-2023-01
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Wearable Vibrotactile Stimulation on Pain and Sense in Patients with Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06674668
- Acronym / sponsor ID
- İK-2023-01
- Conditions
- Lateral Epicondylitis, Vibration Therapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, Istanbul Kültür University
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Vibrotactile stimulationThe intervention includes traditional physiotherapy and vibrotactile device use. |
| Control group | Active comparator | Other: Traditional physiotherapyFor traditional physiotherapy, passive stretching exercises, radial head mobilization and deep friction massage will be applied to the affected extremity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being between 18-65 years of age
- Patients diagnosed with lateral epicondylitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile stimulationThe 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). | Other | Intervention group |
| Traditional physiotherapyFor 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. | Other | Control group |
Primary outcome
Pain Severity
Time frame: from pre-interventional time to post-interventional about 1st hour
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).
Pressure pain threshold
Time frame: from pre-interventional time to post-interventional about 1st hour
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.
Joint position sense
Time frame: from pre-interventional time to post-interventional about 1st hour
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.
3 secondary outcomes
Hand grip sensitivity level
Time frame: from pre-interventional time to post-interventional about 1st hour
Grip Strength
Time frame: from pre-interventional time to post-interventional about 1st hour
Functional assessment
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile stimulation and Traditional physiotherapy in people with Lateral Epicondylitis and Vibration Therapy, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imge NAS (+902124984141, i.nas@iku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: from pre-interventional time to post-interventional about 1st hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.