Lateral EpicondylitisNCT03794219
Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?
A study testing Kinesio Tape and oral naproxen in people with Lateral Epicondylitis, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is characterized by a pain in the lateral epicondyle of the humerus and the common extensor tendon. The incidence of LE is approximately one to three percent of general population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Kinesio Tape and oral naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2019to 1 Aug 2019
- 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
- the presence of pain in the lateral elbow region at least for three months
- tenderness around the lateral humeral epicondyle following at least one of these provocation tests: resisted wrist extension, resisted middle finger extension or passive stretch of wrist extensors.
Who cannot join
- bilateral LE
- presence of trigger point in the extensor muscles of the forearm
- history of proximal upper extremity or neck symptoms
- cervical pathology
- central or peripheral neurologic disease
- nerve entrapment syndromes
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- surgical treatments for LE
- presence of condition that may prevent the patient using NSAIDs (i.e. gastrointestinal disorders, using anticoagulant)
- trauma history of upper extremity
- previous steroid injection around the lateral epicondyle
- physical therapy targeted for LE in the past 6 months
- presence of structures like fibrous bands, arc or recurrent radial artery around the radial nerve that may cause the entrapment of nerve
- pregnancy and having any systemic disease that may cause swelling at nerves such as diabetes mellitus, renal insufficiency, thyroid disease or rheumatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study.
Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is characterized by a pain in the lateral epicondyle of the humerus and the common extensor tendon. The incidence of LE is approximately one to three percent of general population. LE is mostly the result of the overuse and repetitive movements of wrists and hands because of occupational or recreational activities. Diagnosis depends on clinical symptoms, history and physical examination including manual provocation tests. Magnetic resonance imaging, ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not response to conservative treatments. It is known that the radial nerve cross sectional-areas (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal. There is insufficient evidence to prove the superiority of any of conservative treatments to the others in patients with LE. The literature indicates that Kinesio taping decreases pain intensity, recovers grip strength, and improves functional status in patients with LE. The investigators design a randomized, single-blind, controlled trail to evaluate the effects of Kinesio taping both clinical and using ultrasonography.
Read the detailed description
After obtaining written informed consent, patients of clinically diagnosed with LE are randomized into intervention and control group. To all patients, activity modification is suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6 sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs. The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the treatment.
- Conditions
- Lateral Epicondylitis
- Being tested
- Kinesio Tape, oral naproxen
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeOther
To all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions.
oral naproxenDrug
750 mg/day oral naproxen is administered for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape plus NSAID | Experimental | Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen. Receives: Other: Kinesio Tape; Drug: oral naproxen |
| NSAID | Active comparator | 750 mg/day oral naproxen is administered for 10 days. Receives: Drug: oral naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 2nd and 6th weeks
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).
Measured: Pre-treatment, 2nd and 6th weeks after treatment
Secondary outcomes (3)
Change from baseline of functional status on 2nd and 6th weeks
Using Patient-Rated Forearm Evaluation Questionnare (PRTEQ) to evaluate functional status. The PRTEQ is a 15-item questionnaire which has two subscale: pain subscale and function subscale.. It is shown to be a reliable and valid tool for measuring pain and function in patients with LE. Pain subscale is comprised of 5 questions, and function subscale is comprised of 10 questions. The total score is calculated by the sum of these two subscales.
Measured: Pre-treatment, 2nd and 6th weeks after treatment
Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks
Using the musculoskeletal ultrasonography to measure CET thickness.
Measured: Pre-treatment, 2nd and 6th weeks after treatment.
Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks
Using the musculoskeletal ultrasonography to measure radial nerve cross-sectional area. Measurements of radial nerve CSA is taken from three different levels: spiral grove, just before bifurcation and between the two heads of supinator muscle (CSA)
Measured: Pre-treatment, 2nd and 6th 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 posted4 Jan 2019
- Study start7 Jan 2019
- Primary completion7 Jul 2019
- Study completion1 Aug 2019
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.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Basak Mansiz-Kaplan, Ankara Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794219
- Sponsor's protocol ID
- E10654
- Status last verified
- Sep 2019
- First submitted
- 3 Jan 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study.
- ClinicalTrials.gov ID
- NCT03794219
- Acronym / sponsor ID
- E10654
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 4 Jan 2019 (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 (LE) is the most frequent painful musculoskeletal condition, which is characterized by a pain in the lateral epicondyle of the humerus and the common extensor tendon. The incidence of LE is approximately one to three percent of general population. LE is mostly the result of the overuse and repetitive movements of wrists and hands because of occupational or recreational activities. Diagnosis depends on clinical symptoms, history and physical examination including manual provocation tests. Magnetic resonance imaging, ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not response to conservative treatments. It is known that the radial nerve cross sectional-areas (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal. There is insufficient evidence to prove the superiority of any of conservative treatments to the others in patients with LE. The literature indicates that Kinesio taping decreases pain intensity, recovers grip strength, and improves functional status in patients with LE. The investigators design a randomized, single-blind, controlled trail to evaluate the effects of Kinesio taping both clinical and using ultrasonography.
Detailed description
After obtaining written informed consent, patients of clinically diagnosed with LE are randomized into intervention and control group. To all patients, activity modification is suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6 sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs. The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape plus NSAID | Experimental | Other: Kinesio Tape, Drug: oral naproxenKinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen. |
| NSAID | Active comparator | Drug: oral naproxen750 mg/day oral naproxen is administered for 10 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of pain in the lateral elbow region at least for three months
- tenderness around the lateral humeral epicondyle following at least one of these provocation tests: resisted wrist extension, resisted middle finger extension or passive stretch of wrist extensors.
Key exclusion criteria (13 listed)
- bilateral LE
- presence of trigger point in the extensor muscles of the forearm
- history of proximal upper extremity or neck symptoms
- cervical pathology
- central or peripheral neurologic disease
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 |
|---|---|---|
| Kinesio TapeTo all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions. | Other | Kinesio tape plus NSAID |
| oral naproxen750 mg/day oral naproxen is administered for 10 days. | Drug | Kinesio tape plus NSAID, NSAID |
Primary outcome
Change from baseline of pain on 2nd and 6th weeks
Time frame: Pre-treatment, 2nd and 6th weeks after treatment
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).
3 secondary outcomes
Change from baseline of functional status on 2nd and 6th weeks
Time frame: Pre-treatment, 2nd and 6th weeks after treatment
Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks
Time frame: Pre-treatment, 2nd and 6th weeks after treatment.
Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks
Time frame: Pre-treatment, 2nd and 6th 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 20 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tape and oral naproxen in people with Lateral Epicondylitis, run by Ankara Education and Research Hospital 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 13 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 20 Sep 2019. 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?
Change from baseline of pain on 2nd and 6th weeks (time frame: Pre-treatment, 2nd and 6th weeks after treatment). 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 20 Sep 2019.