Tennis ElbowNCT06382805
Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis
A study testing Physiotherapy program, Kinesio Tape and High Intensity Laser therapy in people with Tennis Elbow and Physical Therapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tennis Elbow, Physical Therapy, Kinesiotaping
- What is being tested?
- Physiotherapy program, Kinesio Tape and High Intensity Laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 25 Nov 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients over 18 years of age.
- Those who have pain with palpation applied to the lateral epicondyle
- Patients with pain in resisted extension of the wrist and/or middle finger
- Pain during static stretching applied to the wrist while the elbow is extended
- The complaints must last at least three months
- Not having received treatment in the last three months.
Who cannot join
- Pregnant and breastfeeding women
- History of fracture or surgery in the elbow area
- Detection of calcific tendinitis on plain radiograph of the elbow
- History of neurological disease
- History of osteoporosis, malignancy, hemophilia
- Rheumatoid arthritis and other inflammatory diseases
- Cognitive problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman training and research hospital
Adıyaman, 02000
About this study
Official title: Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy on Pain, Grip Strength and Functional Level in Patients with Lateral Epicondylitis: a Randomized Controlled Study.
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis.
Read the detailed description
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. It is usually a non-inflammatory tendinopathy of the extensor carpi radialis and extensor digitorum comminis. Calcific tendinitis and/or partial tears in the wrist extensor muscles may accompany this condition. It is most common between the ages of 30-60 and its prevalence has been reported as 1-1.7% Although the underlying cause is mostly unknown, activities that involve excessive use of wrist extensors and supinators are thought to be the most important cause of lateral epicondylitis .The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. Non-surgical treatment approaches such as patient education physiotherapy applications, manual therapy, laser therapy, splinting, taping, exercises, massage and local injection, as well as oral or topical nonsteroidal anti-inflammatory drugs are frequently applied. Kinesio tape, which is frequently used in musculoskeletal system injuries, is flexible, mimics skin and has a water-resistant structure. Kinesio tape creates a pumping system by pulling the skin up in the area where it is applied, thus increasing the skin space, increasing blood and lymph circulation, and creating analgesia and proprioceptive sensory input by reducing the pressure on pain receptors . There are scientific studies showing that kinesio tape application reduces pain and increases functionality and grip strength in patients with lateral apicondylitis. It is stated that high-intensity laser treatment can quickly create photochemical and photothermic effects in deep tissue. For this reason, collagen production in tendons is stimulated and can increase blood flow, vascular permeability and cell metabolism. As a result of all these events, tissue healing begins and painful stimuli disappear. It has been shown that high-intensity laser reduces pain and increases functionality and grip strength in patients with lateral epicondylitis. In the literature review, no randomized controlled studies were found comparing high-intensity laser and kinesio tape applications in patients with lateral epicondylitis
- Conditions
- Tennis Elbow, Physical Therapy, Kinesiotaping, Laser
- Being tested
- Physiotherapy program, Kinesio Tape, High Intensity Laser therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy programOther
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. Cold-pack will be applied for 15 minutes. Continuous ultrasound will be applied on lateral epicondylitis with a 5-cm ultrasound head at a dose of 1.5W/cm2 for 5 minutes and a frequency of 1-MHZ. TENS application will be performed with the BTL 4000 combination device. TENS will be applied for 20 minutes, increasing the intensity of the current until the patient feels it. The treatment program will last for a total of two weeks, 5 days a week.
Kinesio TapeOther
The longitudinal muscle technique will be applied from the origin to the insertion of the forearm extensor muscles by a researcher with a Kinesio tape application certificate. In addition, transverse kinesio tape will be applied on the elbow using the fascia correction technique. The treatment program will last for a total of two weeks, 5 days a week.
High Intensity Laser therapyOther
High intensity laser applications will be performed using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area for 75 seconds at a dose of 4W 6 J/cm2 (analgesic effect) by making circular movements from the center to the outside. The remaining 5 sessions will be applied to the painful area with linear movements for 12 minutes and 30 seconds at a dose of 6W 100-150 J/cm2 (biostimulation effect). The treatment program will last for a total of two weeks, 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. Receives: Other: Physiotherapy program |
| kinesiotaping group | Active comparator | Kinesio tape application will be applied to the kinesio tape group in addition to physiotherapy.
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. Receives: Other: Physiotherapy program; Other: Kinesio Tape |
| high intensity laser therapy group | Active comparator | High-intensity laser application will be applied to the high-intensity laser group in addition to physiotherapy. The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. Receives: Other: Physiotherapy program; Other: High Intensity Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measurement
Patients' lateral epicondylitis pain intensity will be evaluated with a visual analog scale (VAS). On the visual analog scale, the left end of a 10 cm straight line represents no pain, and the right end represents excruciating pain. The patient will be asked to mark the pain he feels on the VAS scale during the test, and then this value will be measured and recorded with the help of a ruler.
Measured: Pain will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Hand grip strength
A standard hand dynamometer (Jamar® Plus + Digital Hand Dynamometer from Patterson Medical, Sammons Preston, Bolingbrook, USA) will be used to measure grip strength. The Jamar dynamometer has high reliability and validity; therefore the device has been considered the gold standard for assessing grip strength. Grip strength evaluation will be performed with patients in a sitting position from a chair. During the test, patients will be asked to position their elbows in 90° flexion and their forearms and wrists in neutral position. The test will be repeated 3 times with one minute intervals and the average of the obtained values will be recorded.
Measured: Hand grip strength will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Patient-Rated Tennis Elbow Evaluation
Functional levels of the patients will be assessed with a Patient-Rated Tennis Elbow Evaluation questionnaire. The questionnaire consists of a total of 15 questions evaluating the functional level of patients with lateral epicondylitis in the last week. 5 questions evaluate pain and the other 10 questions evaluate functional level in various tasks. The score for each question is between 0 (best) and 10 (worst). The best score that can be obtained in the section that evaluates functionality is 0, while the worst score is 100.
Measured: Patient-Rated Tennis Elbow Evaluation will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Secondary outcomes (1)
Pain Sensitivity Measurement
Pain sensitivity will be measured with a pressure pain meter (JTECH Medical, Midvale, UT, USA). Measurements will be made by the same researcher under the same conditions. The researcher will press a 1 cm2 probe perpendicularly to the affected lateral epicondyle and the first point where the patient feels pain will be recorded. Measurements will be repeated 3 times and the average of these values will be taken.
Measured: Pain Sensitivity Measurement will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start2 May 2024
- Primary completion11 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abuzer akbaş, Hasan Kalyoncu University
- Investigators
- abuzer akbas, Principal investigator, hasan kalyoncu university faculty of health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382805
- Sponsor's protocol ID
- HasanKU_FTR_AA_02
- Status last verified
- Nov 2024
- First submitted
- 20 Apr 2024
- Last updated
- 27 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy on Pain, Grip Strength and Functional Level in Patients with Lateral Epicondylitis: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06382805
- Acronym / sponsor ID
- HasanKU_FTR_AA_02
- Conditions
- Tennis Elbow, Physical Therapy, Kinesiotaping, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 24 Apr 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.
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis.
Detailed description
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. It is usually a non-inflammatory tendinopathy of the extensor carpi radialis and extensor digitorum comminis. Calcific tendinitis and/or partial tears in the wrist extensor muscles may accompany this condition. It is most common between the ages of 30-60 and its prevalence has been reported as 1-1.7% Although the underlying cause is mostly unknown, activities that involve excessive use of wrist extensors and supinators are thought to be the most important cause of lateral epicondylitis .The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. Non-surgical treatment approaches such as patient education physiotherapy applications, manual therapy, laser therapy, splinting, taping, exercises, massage and local injection, as well as oral or topical nonsteroidal anti-inflammatory drugs are frequently applied. Kinesio tape, which is frequently used in musculoskeletal system injuries, is flexible, mimics skin and has a water-resistant structure. Kinesio tape creates a pumping system by pulling the skin up in the area where it is applied, thus increasing the skin space, increasing blood and lymph circulation, and creating analgesia and proprioceptive sensory input by reducing the pressure on pain receptors . There are scientific studies showing that kinesio tape application reduces pain and increases functionality and grip strength in patients with lateral apicondylitis. It is stated that high-intensity laser treatment can quickly create photochemical and photothermic effects in deep tissue. For this reason, collagen production in tendons is stimulated and can increase blood flow, vascular permeability and cell metabolism. As a result of all these events, tissue healing begins and painful stimuli disappear. It has been shown that high-intensity laser reduces pain and increases functionality and grip strength in patients with lateral epicondylitis. In the literature review, no randomized controlled studies were found comparing high-intensity laser and kinesio tape applications in patients with lateral epicondylitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Physiotherapy programThe physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. |
| kinesiotaping group | Active comparator | Other: Physiotherapy program, Other: Kinesio TapeKinesio tape application will be applied to the kinesio tape group in addition to physiotherapy. The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. |
| high intensity laser therapy group | Active comparator | Other: Physiotherapy program, Other: High Intensity Laser therapyHigh-intensity laser application will be applied to the high-intensity laser group in addition to physiotherapy. The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- Those who have pain with palpation applied to the lateral epicondyle
- Patients with pain in resisted extension of the wrist and/or middle finger
- Pain during static stretching applied to the wrist while the elbow is extended
- The complaints must last at least three months
Key exclusion criteria (7 listed)
- Pregnant and breastfeeding women
- History of fracture or surgery in the elbow area
- Detection of calcific tendinitis on plain radiograph of the elbow
- History of neurological disease
- History of osteoporosis, malignancy, hemophilia
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 |
|---|---|---|
| Physiotherapy programThe physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. Cold-pack will be applied for 15 minutes. Continuous ultrasound will be applied on lateral epicondylitis with a 5-cm ultrasound head at a dose of 1.5W/cm2 for 5 minutes and a frequency of 1-MHZ. TENS application will be performed with the BTL 4000 combination device. TENS will be applied for 20 minutes, increasing the intensity of the current until the patient feels it. The treatment program will last for a total of two weeks, 5 days a week. | Other | Control group, high intensity laser therapy group, kinesiotaping group |
| Kinesio TapeThe longitudinal muscle technique will be applied from the origin to the insertion of the forearm extensor muscles by a researcher with a Kinesio tape application certificate. In addition, transverse kinesio tape will be applied on the elbow using the fascia correction technique. The treatment program will last for a total of two weeks, 5 days a week. | Other | kinesiotaping group |
| High Intensity Laser therapyHigh intensity laser applications will be performed using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area for 75 seconds at a dose of 4W 6 J/cm2 (analgesic effect) by making circular movements from the center to the outside. The remaining 5 sessions will be applied to the painful area with linear movements for 12 minutes and 30 seconds at a dose of 6W 100-150 J/cm2 (biostimulation effect). The treatment program will last for a total of two weeks, 5 days a week. | Other | high intensity laser therapy group |
Primary outcome
Pain Measurement
Time frame: Pain will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Patients' lateral epicondylitis pain intensity will be evaluated with a visual analog scale (VAS). On the visual analog scale, the left end of a 10 cm straight line represents no pain, and the right end represents excruciating pain. The patient will be asked to mark the pain he feels on the VAS scale during the test, and then this value will be measured and recorded with the help of a ruler.
Hand grip strength
Time frame: Hand grip strength will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
A standard hand dynamometer (Jamar® Plus + Digital Hand Dynamometer from Patterson Medical, Sammons Preston, Bolingbrook, USA) will be used to measure grip strength. The Jamar dynamometer has high reliability and validity; therefore the device has been considered the gold standard for assessing grip strength. Grip strength evaluation will be performed with patients in a sitting position from a chair. During the test, patients will be asked to position their elbows in 90° flexion and their forearms and wrists in neutral position. The test will be repeated 3 times with one minute intervals and the average of the obtained values will be recorded.
Patient-Rated Tennis Elbow Evaluation
Time frame: Patient-Rated Tennis Elbow Evaluation will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Functional levels of the patients will be assessed with a Patient-Rated Tennis Elbow Evaluation questionnaire. The questionnaire consists of a total of 15 questions evaluating the functional level of patients with lateral epicondylitis in the last week. 5 questions evaluate pain and the other 10 questions evaluate functional level in various tasks. The score for each question is between 0 (best) and 10 (worst). The best score that can be obtained in the section that evaluates functionality is 0, while the worst score is 100.
1 secondary outcome
Pain Sensitivity Measurement
Time frame: Pain Sensitivity Measurement will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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.
abuzer akbas principal investigator
hasan kalyoncu university faculty of health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy program, Kinesio Tape and High Intensity Laser therapy in people with Tennis Elbow and Physical Therapy, run by Hasan Kalyoncu 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Measurement (time frame: Pain will be evaluated before treatment, immediately after treatment and 6 weeks after treatment). 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 27 Nov 2024.