Lateral Epicondylitis (tennis Elbow)NCT06611709
Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis
A study testing Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold and exercises in people with Lateral Epicondylitis (tennis Elbow) and Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis significantly impacts daily activities and productivity at work, making it a condition of substantial clinical and socioeconomic importance.Despite its high prevalence, clinical significance, and impact on daily life, the optimal management of LE remains a topic of ongoing debate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis (tennis Elbow), Pain
- What is being tested?
- Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold and exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Sep 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
- Adults aged 18 to 65 years
- A pain severity of 4 or higher on the visual analog scale (VAS) during daily activities
- A history of lateral epicondylitis symptoms lasting at least three months
Who cannot join
- Communication difficulties
- Significant psychiatric disorders
- A history of trauma within the past six months
- Neuromuscular conditions
- Abnormalities of the upper limb
- Prior upper limb surgery
Show all 9Show fewer
- A history of rheumatic diseases
- Cervical disc pathology, polyneuropathy, or hand disorders (such as carpal or cubital tunnel syndrome, de Quervain tenosynovitis, osteoarthritis)
- Receipt of any treatment for lateral epicondylitis (e.g., local injections, physical therapy, splints) within the last six month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Research and Training Hospital, Physical Medicine and Rehabilitation clinics
Konya, Selçuklu, 42060
About this study
Official title: Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis: a Randomized, Sham-controlled, Single-blind Study
Lateral epicondylitis significantly impacts daily activities and productivity at work, making it a condition of substantial clinical and socioeconomic importance.Despite its high prevalence, clinical significance, and impact on daily life, the optimal management of LE remains a topic of ongoing debate.
This study aims to investigate the efficacy of kinesiotaping (KT) on pain intensity, functional status, and quality of life in patients with chronic lateral epicondylitis (LE).
The study was conducted in the outpatient clinic for level 3 physical medicine and rehabilitation. Patients were randomized into two groups: the real kinesiotaping + home exercise group and the sham taping + home exercise group (randomized by a medical secretary outside the study). A set of widely accepted, literature-consistent primer and seconder outcomes were statistically compared to determine whether one treatment was superior to the other.
Read the detailed description
Between February 1, 2024, and August 31, 2024, a total of 42 patients (17 females, 25 males) with chronic LE were included. Patients were randomized into either the KT or sham-controlled group. Patients were blinded to which group they were assigned to. The taping was performed by the same physician, who was trained and experienced in kinesiotaping.
Kinesiotaping and sham-taping were applied six times over three weeks. Both groups received recommendations for activity modification and a home-based stretching and strengthening exercise program. The exercise program was designed by an author who has a national book chapter on exercise for the treatment of lateral epicondylitis, taking into account patient specificity and adherence, and in accordance with the literaturExercise adherence was monitored through weekly outpatient controls (while taping) and by phone check-ins two weeks after the taping was completed.
Outcome measures were visual analog scale (VAS) pain score, Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), grip strength, Disabilities of Arm, Shoulder, and Hand (DASH), quality of life in Short Form-36 (SF-36), and The Roles and Maudsley patient satisfaction score. The subjects were assessed before treatment, at the end of treatment (week three), and four weeks after the end of treatment (week seven).The assessment parameters were also conducted by the same researcher to ensure consistency.
- Conditions
- Lateral Epicondylitis (tennis Elbow), Pain
- Being tested
- sham taping (non-elastic medical cloth tape), Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold, exercises
- Keywords
- kinesiotaping, lateral epicondylitis, pain, exercises
- Medical subject headings
- Tennis Elbow, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham taping (non-elastic medical cloth tape)Device
sham taping
Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex GoldDevice
A standard 5-cm wide KinesioⓇ Tex Gold
exercisesOther
home-based exercises
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping | Experimental | Kinesiotaping (real) + exercises Receives: Device: Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold; Other: exercises |
| Sham-taping | Sham comparator | Sham-taping (non-elastic medical cloth tape) + exercises Receives: Device: sham taping (non-elastic medical cloth tape); Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
0 (best) to 100 (worst)
Measured: baseline, week 3, and week 7
VAS pain (0-10)
0 no pain; 10 unbearable/max. pain.
Measured: baseline, week 3, and week 7
Secondary outcomes (4)
The Disabilities of the Arm, Shoulder, and Hand (DASH)
0 (best condition) to 100 (worst condition)
Measured: baseline, week 3, and week 7
grip strength
using a Jamar® dynamometer (in kilograms)
Measured: baseline, week 3, and week 7
The Short Form-36 (SF-36) quality of life index
0, indicating the worst health status, to 100, representing the best possible health
Measured: baseline, week 3, and week 7
Patient satisfaction/benefit scale (The Roles and Maudsley score)
The Roles and Maudsley score was utilized to evaluate pain and activity limitations in the assessment of treatment efficacy, categorized into four levels: 1 point indicating excellent, 2 points indicating good, 3 points indicating fair, and 4 points indicating poor.
Measured: baseline, week 3, and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Feb 2024
- Primary completion31 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral Epicondylitis (tennis Elbow)Studies 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
- Kinesiotaping vs sham-taping
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Yılmaz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611709
- Sponsor's protocol ID
- KonyaBeyhekimTRH2024
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akkurt HE, Yilmaz R, Suna FS, Karpuz S, Yilmaz H. The effectiveness of kinesiotaping in treating chronic lateral epicondylitis: a randomized, sham-controlled, single-blind study. J Orthop Surg Res. 2025 Mar 14;20(1):274. doi: 10.1186/s13018-025-05658-7.
PubMed 40082899
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis: a Randomized, Sham-controlled, Single-blind Study
- ClinicalTrials.gov ID
- NCT06611709
- Acronym / sponsor ID
- KonyaBeyhekimTRH2024
- Conditions
- Lateral Epicondylitis (tennis Elbow), Pain
- Keywords
- kinesiotaping, lateral epicondylitis, pain, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 25 Sep 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 significantly impacts daily activities and productivity at work, making it a condition of substantial clinical and socioeconomic importance.Despite its high prevalence, clinical significance, and impact on daily life, the optimal management of LE remains a topic of ongoing debate.
This study aims to investigate the efficacy of kinesiotaping (KT) on pain intensity, functional status, and quality of life in patients with chronic lateral epicondylitis (LE).
The study was conducted in the outpatient clinic for level 3 physical medicine and rehabilitation. Patients were randomized into two groups: the real kinesiotaping + home exercise group and the sham taping + home exercise group (randomized by a medical secretary outside the study). A set of widely accepted, literature-consistent primer and seconder outcomes were statistically compared to determine whether one treatment was superior to the other.
Detailed description
Between February 1, 2024, and August 31, 2024, a total of 42 patients (17 females, 25 males) with chronic LE were included. Patients were randomized into either the KT or sham-controlled group. Patients were blinded to which group they were assigned to. The taping was performed by the same physician, who was trained and experienced in kinesiotaping.
Kinesiotaping and sham-taping were applied six times over three weeks. Both groups received recommendations for activity modification and a home-based stretching and strengthening exercise program. The exercise program was designed by an author who has a national book chapter on exercise for the treatment of lateral epicondylitis, taking into account patient specificity and adherence, and in accordance with the literaturExercise adherence was monitored through weekly outpatient controls (while taping) and by phone check-ins two weeks after the taping was completed.
Outcome measures were visual analog scale (VAS) pain score, Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), grip strength, Disabilities of Arm, Shoulder, and Hand (DASH), quality of life in Short Form-36 (SF-36), and The Roles and Maudsley patient satisfaction score. The subjects were assessed before treatment, at the end of treatment (week three), and four weeks after the end of treatment (week seven).The assessment parameters were also conducted by the same researcher to ensure consistency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Kinesiotaping vs sham-taping
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping | Experimental | Device: Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold, Other: exercisesKinesiotaping (real) + exercises |
| Sham-taping | Sham comparator | Device: sham taping (non-elastic medical cloth tape), Other: exercisesSham-taping (non-elastic medical cloth tape) + exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 65 years
- A pain severity of 4 or higher on the visual analog scale (VAS) during daily activities
- A history of lateral epicondylitis symptoms lasting at least three months
Key exclusion criteria (9 listed)
- Communication difficulties
- Significant psychiatric disorders
- A history of trauma within the past six months
- Neuromuscular conditions
- Abnormalities of the upper limb
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 |
|---|---|---|
| sham taping (non-elastic medical cloth tape)sham taping | Device | Sham-taping |
| Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex GoldA standard 5-cm wide KinesioⓇ Tex Gold | Device | Kinesiotaping |
| exerciseshome-based exercises | Other | Kinesiotaping, Sham-taping |
Primary outcome
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
Time frame: baseline, week 3, and week 7
0 (best) to 100 (worst)
VAS pain (0-10)
Time frame: baseline, week 3, and week 7
0 no pain; 10 unbearable/max. pain.
4 secondary outcomes
The Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: baseline, week 3, and week 7
grip strength
Time frame: baseline, week 3, and week 7
The Short Form-36 (SF-36) quality of life index
Time frame: baseline, week 3, and week 7
Patient satisfaction/benefit scale (The Roles and Maudsley score)
Time frame: baseline, week 3, and week 7
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 25 Sep 2024.
- Derived from this study: PubMed 40082899Akkurt HE, Yilmaz R, Suna FS, Karpuz S, Yilmaz H. The effectiveness of kinesiotaping in treating chronic lateral epicondylitis: a randomized, sham-controlled, single-blind study. J Orthop Surg Res. 2025 Mar 14;20(1):274. doi: 10.1186/s13018-025-05658-7.
- Individual participant dataSharing planned: Undecided
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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 Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold and exercises in people with Lateral Epicondylitis (tennis Elbow) and Pain, run by Konya Beyhekim Training 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 3 inclusion and 9 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 25 Sep 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. Some participants in this study may receive a placebo. 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?
Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE) (time frame: baseline, week 3, and week 7). 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?
On the ClinicalTrials.gov record for NCT06611709, which also lists 1 linked publication.
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 25 Sep 2024.