Lateral EpicondylitisNCT06730789
Conservative Treatment in Lateral Epicondylitis
A study testing Epicondylitis bandage, Wrist dorsiflexion splint and Kinesio tape in people with Lateral Epicondylitis, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Conservative treatments follow the vast majority of treatments in lateral epicondylitis. In this research, we aimed to elucidate the treatment outcomes of patients via epicondylitis bandage, wrist dorsiflexion splint, and kinesio tape groups by sequential randomization and to compare treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Epicondylitis bandage, Wrist dorsiflexion splint and Kinesio tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 15 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were ≥18 years of age, and had no history of elbow surgery.
- Participants should have pain and sensitivity, with symptom duration less than 12 weeks.
- Patients with a positive result in one of the provocation tests (Maudsley's Test-resisted middle finger extension extensor carpi radialis test), resisted wrist extension, or passive stretching of the wrist extensors (Mill's Test) were included.
Who cannot join
- Patients under 18 years of age,
- patients who did not consent to participate in the study,
- those who had previous surgery on the elbow,
- presence of cervical spondylosis and radiculopathy,
- presence of endocrine disease,
- presence of autoimmune disease,
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- presence of concomitant entrapment neuropathy or polyneuropathy,
- pregnancy,
- presence of systemic inflammatory disease,
- presence of acute trauma,
- presence of deformity in the upper extremity,
- presence of metabolic disease,
- presence of elbow arthritis,
- presence of allergy to kinesio tape and orthoses,
- having received treatment for lateral epicondylitis in the past (exercise, injection, NSAIDs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison of Conservative Treatment Methods in Patients With Lateral Epicondylitis
Conservative treatments follow the vast majority of treatments in lateral epicondylitis. In this research, we aimed to elucidate the treatment outcomes of patients via epicondylitis bandage, wrist dorsiflexion splint, and kinesio tape groups by sequential randomization and to compare treatment outcomes.
- Conditions
- Lateral Epicondylitis
- Being tested
- Epicondylitis bandage, Wrist dorsiflexion splint, Kinesio tape
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicondylitis bandageDevice
A conservative treatment method of lateral epicondylitis.
Wrist dorsiflexion splintDevice
A conservative treatment method of lateral epicondylitis.
Kinesio tapeDevice
A conservative treatment method of lateral epicondylitis
| Study group | Role | What they receive |
|---|---|---|
| Lateral Epicondylitis (treatment with epicondylitis bandage) | Experimental | Patients with diagnosis of lateral epicondylitis. Receives: Device: Epicondylitis bandage |
| Lateral Epicondylitis (treatment with wrist dorsiflexion orthesis) | Experimental | Patients with diagnosis of lateral epicondylitis. Receives: Device: Wrist dorsiflexion splint |
| Lateral Epicondylitis (treatment with kinesio tape) | Experimental | Patients with diagnosis of lateral epicondylitis. Receives: Device: Kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog score
Minimum value: 0 Maximum value: 10 Minimum is better.
Measured: Baseline
Visual analog score
Minimum value: 0 Maximum value:10 Minimum is better.
Measured: At sixth weeks.
Secondary outcomes (2)
Disabilities of the Arm, Shoulder Score
Minimum value:0 Maximum value:100 Minimum is better
Measured: Baseline
Disabilities of the Arm, Shoulder Score
Minimum value:0 Maximum value:100 Minimum is better
Measured: At sixth weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start15 Dec 2020
- Primary completion15 Dec 2021
- Study completion15 May 2022
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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yücel Bilgin, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730789
- Sponsor's protocol ID
- IEAH-YB-2020-01
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Conservative Treatment Methods in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06730789
- Acronym / sponsor ID
- IEAH-YB-2020-01
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 12 Dec 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.
Conservative treatments follow the vast majority of treatments in lateral epicondylitis. In this research, we aimed to elucidate the treatment outcomes of patients via epicondylitis bandage, wrist dorsiflexion splint, and kinesio tape groups by sequential randomization and to compare treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lateral Epicondylitis (treatment with epicondylitis bandage) | Experimental | Device: Epicondylitis bandagePatients with diagnosis of lateral epicondylitis. |
| Lateral Epicondylitis (treatment with wrist dorsiflexion orthesis) | Experimental | Device: Wrist dorsiflexion splintPatients with diagnosis of lateral epicondylitis. |
| Lateral Epicondylitis (treatment with kinesio tape) | Experimental | Device: Kinesio tapePatients with diagnosis of lateral epicondylitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who were ≥18 years of age, and had no history of elbow surgery.
- Participants should have pain and sensitivity, with symptom duration less than 12 weeks.
- Patients with a positive result in one of the provocation tests (Maudsley's Test-resisted middle finger extension extensor carpi radialis test), resisted wrist extension, or passive stretching of the wrist extensors (Mill's Test) were included.
Key exclusion criteria (15 listed)
- Patients under 18 years of age,
- patients who did not consent to participate in the study,
- those who had previous surgery on the elbow,
- presence of cervical spondylosis and radiculopathy,
- presence of endocrine 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 |
|---|---|---|
| Epicondylitis bandageA conservative treatment method of lateral epicondylitis. | Device | Lateral Epicondylitis (treatment with epicondylitis bandage) |
| Wrist dorsiflexion splintA conservative treatment method of lateral epicondylitis. | Device | Lateral Epicondylitis (treatment with wrist dorsiflexion orthesis) |
| Kinesio tapeA conservative treatment method of lateral epicondylitis | Device | Lateral Epicondylitis (treatment with kinesio tape) |
Primary outcome
Visual analog score
Time frame: Baseline
Minimum value: 0 Maximum value: 10 Minimum is better.
Visual analog score
Time frame: At sixth weeks.
Minimum value: 0 Maximum value:10 Minimum is better.
2 secondary outcomes
Disabilities of the Arm, Shoulder Score
Time frame: Baseline
Disabilities of the Arm, Shoulder Score
Time frame: At sixth weeks.
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 12 Dec 2024.
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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 Epicondylitis bandage, Wrist dorsiflexion splint and Kinesio tape in people with Lateral Epicondylitis, run by Uludag 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 3 inclusion and 15 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 12 Dec 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?
Visual analog score (time frame: Baseline). The study lists 2 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 12 Dec 2024.