Tendinopathy, ElbowNCT04518527
Efficiency of Kinesio Taping in Chronic Lateral Epicondylitis
A study testing Tape in people with Tendinopathy, Elbow, run by Elif Balevi Batur at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis is a degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Tendinopathy, Elbow
- What is being tested?
- Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Jul 2017
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
- Unilateral elbow pain at least 12 weeks,
- Not received injection therapy to the elbow in the last six weeks,
- Not received a physical therapy program in the last three months,
- Presence of normal elbow radiographic findings,
- Normal elbow joint range of motion,
- Having no neurological deficits
Who cannot join
- Patients with degenerative joint disease,
- Radial tunnel syndrome,
- Cervical nerve root compression,
- Pain reflected from the neck, shoulders,
- Wrist, radiohumeral joint osteochondritis dissecans,
- Tendon rupture,
Show all 10Show fewer
- Osteoporosis, Infection,
- Malignancy,
- Inflammatory disease,
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Short-term and Residual Effects of Kinesio Taping in Chronic Lateral Epicondylitis: A Randomized, Double-blinded, Controlled Trial
Lateral epicondylitis is a degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow. This randomized, double-blinded, controlled study aimed to evaluate the short term and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life, and functionality.
Read the detailed description
Fifty patients diagnosed with chronic unilateral lateral epicondylitis with a symptom duration of at least 12 weeks. The study group received a true inhibitor Kinesio taping while the control group received sham taping for the first four weeks. In both groups, progressive stretching and strengthening exercises were given as a home program for 6 weeks. Patients were assessed with the numerical rating scale (NRS), Cyriax resistive muscle test evaluation, maximal grip strength, PRTEE (Patient- Rated Tennis Elbow Evaluation), and SF-36 (Short Form-36) by the first assessor who was blinded to taping types.
- Conditions
- Tendinopathy, Elbow
- Being tested
- Tape
- Keywords
- Kinesio taping, lateral epicondylitis, residual effect
- Medical subject headings
- Elbow Tendinopathy, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapeDevice
The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
| Study group | Role | What they receive |
|---|---|---|
| true taping+ exercise | Active comparator | The true taping method was applied to the first group according to the method determined by Kase. According to this method, a 2-inch (5 cm) wide beige-colored Kinesio tape (Kinesio® Tex Gold FP) was measured from the second-third metacarpal base to the lateral epicondyle while the elbow was extended and the wrist was in the neutral position and the tape was applied in the shape of a 'Y'. In a position where the wrist-ankle extensors were most tense (wrist-ankle extension - forearm pronation), the anchor point of the tape was applied to the insertion of the muscle without creating any tension. Then, the tape was applied to the medial and lateral edges of the wrist extensors by applying a 15-25% tension towards the origin of the muscle. Both ends of the Y-shaped tape were terminated without tension on the lateral epicondyle. Receives: Device: Tape |
| sham taping+exercise | Placebo comparator | In the placebo group, the 10 cm I-shaped tape was placed 5 cm inferior to the lateral epicondyle using the same Kinesio tape in the study group. It was applied transversely, starting from the painless side of the midline on the forearm extensor face directing towards the lateral side of the forearm without a tension. Receives: Device: Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale
The numerical rating scale (NRS) was used to evaluate the pain level of the patients included in the study. It is a one-dimensional scale consisting of 11 items that measure pain intensity in adults and is a segmented - intermittent numerical version of the visual analogue scale (VAS).
Measured: 1 year
Secondary outcomes (4)
resisted muscle test evaluation
According to the Cyriax method, each joint tested was kept in the mid- range of motion, without allowing movement. Resistance was applied to the forearm distal to avoid muscle involvement other than that tested in pronation and supination, thus the wrist was prevented to be involved. Subsequently, the patients were asked to apply a maximum force for at least three seconds. Resisted wrist extension, third finger extension, elbow supination, and pronation were evaluated.
Measured: 1 year
Maximal Isometric Handgrip Strength
The maximal isometric handgrip strength was measured in pounds using the Jamar hand dynamometer (Baseline® Hand Dynamometer - HiRes™ Gauge - ER™ 300 lbCapacity). Measurement was performed in two different positions, elbow at extension and 90° flexion. In the first position, the patient was in the sitting position, shoulder abducted to 0° and in neutral rotation, elbow position was at 90° flexion, the forearm was in neutral rotation and wrist was in the neutral position. In the second position, while the patient was standing, shoulder abducted to 0° and in neutral rotation, the elbow was in full extension, forearm and wrist were in the neutral position. The patient was asked to squeeze the dynamometer with full force for three seconds every 30 seconds. This procedure was repeated three times and the mean measurement values were obtained
Measured: 1 year
The Patient-rated Tennis Elbow Evaluation(PRTEE)
The Patient-rated Tennis Elbow Evaluation (PRTEE) is a questionnaire with subscales related to pain and function, which is used to evaluate upper extremity functionality. It is specially prepared for patients with lateral epicondylitis.Scoring ranges from 0 (no pain/disability) to 100 (worst possible pain and disability). The total score can be 100 points maximum and low scores refer to better functionality.Turkish validity and reliability was proven by Altan et al.
Measured: 1 year
36-Item Short-Form Health Survey (SF-36)
The SF-36 is valid and reliable for patients with chronic musculoskeletal disorders. The items include eight different domains that indicate physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score of each domain ranges from 0 (worst quality of life) to 100 (the best quality of life).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Feb 2017
- Primary completion1 May 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendinopathy, 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Balevi Batur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Balevi Batur, Selcuk University
- Investigators
- IŞIL S YENİCE BALEVİ, Principal investigator, Gazi UniversityBELGİN KARAOĞLAN, Study director, Gazi UniversityNAGİHAN ACET, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518527
- Sponsor's protocol ID
- GaziU
- Status last verified
- Feb 2017
- First submitted
- 12 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short-term and Residual Effects of Kinesio Taping in Chronic Lateral Epicondylitis: A Randomized, Double-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT04518527
- Acronym / sponsor ID
- GaziU
- Conditions
- Tendinopathy, Elbow
- Keywords
- Kinesio taping, lateral epicondylitis, residual effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Elif Balevi BaturUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 19 Aug 2020 (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 degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow. This randomized, double-blinded, controlled study aimed to evaluate the short term and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life, and functionality.
Detailed description
Fifty patients diagnosed with chronic unilateral lateral epicondylitis with a symptom duration of at least 12 weeks. The study group received a true inhibitor Kinesio taping while the control group received sham taping for the first four weeks. In both groups, progressive stretching and strengthening exercises were given as a home program for 6 weeks. Patients were assessed with the numerical rating scale (NRS), Cyriax resistive muscle test evaluation, maximal grip strength, PRTEE (Patient- Rated Tennis Elbow Evaluation), and SF-36 (Short Form-36) by the first assessor who was blinded to taping types.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| true taping+ exercise | Active comparator | Device: TapeThe true taping method was applied to the first group according to the method determined by Kase. According to this method, a 2-inch (5 cm) wide beige-colored Kinesio tape (Kinesio® Tex Gold FP) was measured from the second-third metacarpal base to the lateral epicondyle while the elbow was extended and the wrist was in the neutral position and the tape was applied in the shape of a 'Y'. In a position where the wrist-ankle extensors were most tense (wrist-ankle extension - forearm pronation), the anchor point of the tape was applied to the insertion of the muscle without creating any tension. Then, the tape was applied to the medial and lateral edges of the wrist extensors by applying a 15-25% tension towards the origin of the muscle. Both ends of the Y-shaped tape were terminated without tension on the lateral epicondyle. |
| sham taping+exercise | Placebo comparator | Device: TapeIn the placebo group, the 10 cm I-shaped tape was placed 5 cm inferior to the lateral epicondyle using the same Kinesio tape in the study group. It was applied transversely, starting from the painless side of the midline on the forearm extensor face directing towards the lateral side of the forearm without a tension. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
- Unilateral elbow pain at least 12 weeks,
- Not received injection therapy to the elbow in the last six weeks,
- Not received a physical therapy program in the last three months,
- Presence of normal elbow radiographic findings,
Key exclusion criteria (10 listed)
- Patients with degenerative joint disease,
- Radial tunnel syndrome,
- Cervical nerve root compression,
- Pain reflected from the neck, shoulders,
- Wrist, radiohumeral joint osteochondritis dissecans,
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 |
|---|---|---|
| TapeThe tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability | Device | sham taping+exercise, true taping+ exercise |
Primary outcome
numerical rating scale
Time frame: 1 year
The numerical rating scale (NRS) was used to evaluate the pain level of the patients included in the study. It is a one-dimensional scale consisting of 11 items that measure pain intensity in adults and is a segmented - intermittent numerical version of the visual analogue scale (VAS).
4 secondary outcomes
resisted muscle test evaluation
Time frame: 1 year
Maximal Isometric Handgrip Strength
Time frame: 1 year
The Patient-rated Tennis Elbow Evaluation(PRTEE)
Time frame: 1 year
36-Item Short-Form Health Survey (SF-36)
Time frame: 1 year
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 19 Aug 2020.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
IŞIL S YENİCE BALEVİ principal investigator
Gazi University
BELGİN KARAOĞLAN study director
Gazi University
NAGİHAN ACET principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tape in people with Tendinopathy, Elbow, run by Elif Balevi Batur 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 7 inclusion and 10 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 19 Aug 2020. 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?
numerical rating scale (time frame: 1 year). 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 19 Aug 2020.