Tennis ElbowNCT02991560
Effects of Various Taping Techniques in Lateral Epicondylitis on Functional and Ultrasonographic Outcomes
A study testing Strengthening exercises, Intensive Physioytherapy and Kinesio taping in people with Tennis Elbow, run by Hacettepe University.
Trial summary
To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis using the results from ultrasonography and clinical tests. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Strengthening exercises, Intensive Physioytherapy and Kinesio taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Nov 2016
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- pain over the lateral epicondyle, pain during grip strength testing, pain in one of the following tests: extensor carpi radialis test
- -
Who cannot join
- inflammatory, autoimmune, endocrine, or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas, allergies to the adhesive tape, and those who received corticosteroid injection and used any oral anti-inflammatory medicine due to lateral epicondylitis within the previous month
About this study
Official title: Effects of Various Taping Techniques in Lateral Epicondylitis Administered in Addition to an Intensive Physiotherapy Program on Functional and Ultrasonographic Outcomes: a Double-blind, Randomized Controlled Study
To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis using the results from ultrasonography and clinical tests.
Read the detailed description
Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury causing elbow pain, and it is difficult to treat. It is characterized with frequent pain and sensitivity at the lateral section of the elbow, mostly at the extensor tendon (extensor carpi radialis brevis [ECRB]) origin and the extensor digitorum communis [EDC] muscle. It was estimated that annually it occurs in about 1%-3% of adult individuals worldwide. There is no consensus regarding its etiology; however, it has been associated with repetitive movements, smoking, and factors increasing physical load, such as obesity. In recent studies, workplace use of non-naturally positioned elbow and wrist have been associated with elbow pain. In addition, repetitive microtraumas have been known to be triggering injuries.
Pain is the primary complaint in LE patients. Pain increases with activity, and it becomes acute with injury or trauma. LE is associated with decreased extensor muscle strength and variations in biomechanics; however, it has been a matter of debate whether these variations are the cause or the result of LE. In its pathophysiology, three interacting components, namely local tendon pathology, changes in the pain system, and losses in motor function have been reported. Recent studies have highlighted that, rather than an inflammatory condition, tendinosis (chronic symptomatic degeneration of tendon) occurs in the forearm common extensor muscle tendon adhering to the lateral epicondyle of the humerus. Ultrasound evaluations indicate various tendon pathologies, such as tendon thickening, focused hypoechogenic zones, tendon lacerations, and calcification.
LE may heal on its own and usually responds to conservative treatment. In case conservative treatment is inconclusive, surgical methods may be opted for. Several conservative methods are among the treatment options for LE, such as resting, nonsteroidal anti-inflammatory drugs (NSAID), injection treatments, exercises, and physiotherapy programs involving manual therapy techniques, massage, braces, deep friction message, extracorporeal shockwave, low level laser therapy, low frequency electrical stimulation, and other electrophysiological agents. The use of non-elastic taping techniques is an approach utilized in the conservative treatment of LE and there exist reports examining its instantaneous effects on muscle strength, grip strength, and pain; however, it was indicated that further studies are warranted to show the effectiveness of taping. Kinesio Taping®, which involves elastic tapes, is rather a more recent technique used in orthopedic injuries in addition to physiotherapy, and it has been gaining popularity. Even though there are reports indicating the effects of adhesive tape on muscle and grip strength in LE patients, its effectiveness could not be compared with other treatment modalities because of several reasons, such as its instantaneous effects or the lack of a control group.
The literature review shows that, due to the structural differences between athletic tape and Kinesio Tape®, athletic taping applications are rather adopted to control the movement of the joint with pain, to support non-contractile structures, such as ligament and capsule, and for stability. Studies utilizing non-elastic tapes in the treatment of LE are inadequate because they examine effects in the acute period and they lack comparisons. On the other hand, it has been observed that Kinesio Tape® is mostly used for functional support, muscular facilitation, and myofascial relaxation, and studies focusing on the management of lateral epicondylitis are scarce.
The aim of the present study is, in LE patients, to compare the short-term effects of two different taping techniques in addition to an intense physiotherapy program on the severity of pain, grip strength, functional status, joint limitations, and structural changes in tendons that can be indicated by diagnostic USG
- Conditions
- Tennis Elbow
- Being tested
- Strengthening exercises, Intensive Physioytherapy, Kinesio taping, Athletic taping
- Keywords
- physiotherapy, taping, conservative treatment
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exercisesOther
The exercises consisted of 3 sets with 20 repetitions of wrist and elbow flexion; 2 sets with 10 repetitions of wrist extension strengthening starting with 50% of the maximum strength and density increasing the resistance each week; and finally, 2 sets with 10 repetitions of the wrist flexor and extensor muscle groups comprising 20 sec of stretching and 10 sec of relaxing using the healthy hand.
Intensive PhysioytherapyOther
The treatment consisted of a cold pack (enclosed in a moist towel for 12 minutes around the elbow joint), TENS (in an asymmetrical biphasic wave form and burst modulation, current width 150 mms, pulse frequency 5 Hz), and deep transverse friction massage (2 minutes of application to the locally sensitive areas determined through palpation on anterolateral surface of lateral epicondyle) followed by home exercises.
Kinesio tapingDevice
Also called KT
Kinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis
Athletic tapingDevice
Also called AT
By athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape (KT) | Experimental | The KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques Receives: Other: Strengthening exercises; Other: Intensive Physioytherapy; Device: Kinesio taping |
| Athletic taping (AT) | Experimental | An athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands). Receives: Other: Strengthening exercises; Other: Intensive Physioytherapy; Device: Athletic taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH
The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as "without any difficulty"
Measured: 30 days
Secondary outcomes (4)
Grip strength
Grip strength was measured using a Jamar hand dynamometer in kilograms. The measurement was performed 3 times and the mean value was used for evaluation. The patients were seated on an armless chair with 90° flexion of hip and knee. The patients grasped the dynamometer for a maximum of 3 seconds while their shoulders were in adduction-neutral rotation, their wrists were in flexion, and the forearms were in semipronation to provide a stronger grip
Measured: 30 days
USG examinations
USG examinations were performed in real-time using a GE Logiq 7 ultrasound scanner (General Electric Medical Systems, USA) with a linear 12 MHz (10-14 MHz) probe. A standard technique, as outlined by the European Society of Musculoskeletal Skeletal Radiology ultrasound subcommittee32, was employed for all tests
Measured: 30days
Muscle strength
Muscle strength of the wrist flexion and extension was evaluated using the Biodex Multi-joint Isokinetic System 3 Pro. Measurements were performed at two different speeds: 60°/sec and 120°/sec.
Measured: 30days
Pain intensity
Pain intensity was evaluated using the visual analog score (VAS) at night and rest-activity. The patients assigned a value for their pain between 0 and 10 on the VAS scale. In this scale, the absence of pain was marked as 0 while the most severe unbearable pain was expressed as 10.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionNov 2016
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GulOznur KARABICAK, Hacettepe University
- Investigators
- Nilgun Bek, Proffessor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991560
- Sponsor's protocol ID
- HEK 10/83
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Taping Techniques in Lateral Epicondylitis Administered in Addition to an Intensive Physiotherapy Program on Functional and Ultrasonographic Outcomes: a Double-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02991560
- Acronym / sponsor ID
- HEK 10/83
- Conditions
- Tennis Elbow
- Keywords
- physiotherapy, taping, conservative treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis using the results from ultrasonography and clinical tests.
Detailed description
Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury causing elbow pain, and it is difficult to treat. It is characterized with frequent pain and sensitivity at the lateral section of the elbow, mostly at the extensor tendon (extensor carpi radialis brevis [ECRB]) origin and the extensor digitorum communis [EDC] muscle. It was estimated that annually it occurs in about 1%-3% of adult individuals worldwide. There is no consensus regarding its etiology; however, it has been associated with repetitive movements, smoking, and factors increasing physical load, such as obesity. In recent studies, workplace use of non-naturally positioned elbow and wrist have been associated with elbow pain. In addition, repetitive microtraumas have been known to be triggering injuries.
Pain is the primary complaint in LE patients. Pain increases with activity, and it becomes acute with injury or trauma. LE is associated with decreased extensor muscle strength and variations in biomechanics; however, it has been a matter of debate whether these variations are the cause or the result of LE. In its pathophysiology, three interacting components, namely local tendon pathology, changes in the pain system, and losses in motor function have been reported. Recent studies have highlighted that, rather than an inflammatory condition, tendinosis (chronic symptomatic degeneration of tendon) occurs in the forearm common extensor muscle tendon adhering to the lateral epicondyle of the humerus. Ultrasound evaluations indicate various tendon pathologies, such as tendon thickening, focused hypoechogenic zones, tendon lacerations, and calcification.
LE may heal on its own and usually responds to conservative treatment. In case conservative treatment is inconclusive, surgical methods may be opted for. Several conservative methods are among the treatment options for LE, such as resting, nonsteroidal anti-inflammatory drugs (NSAID), injection treatments, exercises, and physiotherapy programs involving manual therapy techniques, massage, braces, deep friction message, extracorporeal shockwave, low level laser therapy, low frequency electrical stimulation, and other electrophysiological agents. The use of non-elastic taping techniques is an approach utilized in the conservative treatment of LE and there exist reports examining its instantaneous effects on muscle strength, grip strength, and pain; however, it was indicated that further studies are warranted to show the effectiveness of taping. Kinesio Taping®, which involves elastic tapes, is rather a more recent technique used in orthopedic injuries in addition to physiotherapy, and it has been gaining popularity. Even though there are reports indicating the effects of adhesive tape on muscle and grip strength in LE patients, its effectiveness could not be compared with other treatment modalities because of several reasons, such as its instantaneous effects or the lack of a control group.
The literature review shows that, due to the structural differences between athletic tape and Kinesio Tape®, athletic taping applications are rather adopted to control the movement of the joint with pain, to support non-contractile structures, such as ligament and capsule, and for stability. Studies utilizing non-elastic tapes in the treatment of LE are inadequate because they examine effects in the acute period and they lack comparisons. On the other hand, it has been observed that Kinesio Tape® is mostly used for functional support, muscular facilitation, and myofascial relaxation, and studies focusing on the management of lateral epicondylitis are scarce.
The aim of the present study is, in LE patients, to compare the short-term effects of two different taping techniques in addition to an intense physiotherapy program on the severity of pain, grip strength, functional status, joint limitations, and structural changes in tendons that can be indicated by diagnostic USG
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 (KT) | Experimental | Other: Strengthening exercises, Other: Intensive Physioytherapy, Device: Kinesio tapingThe KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques |
| Athletic taping (AT) | Experimental | Other: Strengthening exercises, Other: Intensive Physioytherapy, Device: Athletic tapingAn athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pain over the lateral epicondyle, pain during grip strength testing, pain in one of the following tests: extensor carpi radialis test
- -
Key exclusion criteria (1 listed)
- inflammatory, autoimmune, endocrine, or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas, allergies to the adhesive tape, and those who received corticosteroid injection and used any oral anti-inflammatory medicine due to lateral epicondylitis within the previous month
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 |
|---|---|---|
| Strengthening exercisesThe exercises consisted of 3 sets with 20 repetitions of wrist and elbow flexion; 2 sets with 10 repetitions of wrist extension strengthening starting with 50% of the maximum strength and density increasing the resistance each week; and finally, 2 sets with 10 repetitions of the wrist flexor and extensor muscle groups comprising 20 sec of stretching and 10 sec of relaxing using the healthy hand. | Other | Athletic taping (AT), Kinesio tape (KT) |
| Intensive PhysioytherapyThe treatment consisted of a cold pack (enclosed in a moist towel for 12 minutes around the elbow joint), TENS (in an asymmetrical biphasic wave form and burst modulation, current width 150 mms, pulse frequency 5 Hz), and deep transverse friction massage (2 minutes of application to the locally sensitive areas determined through palpation on anterolateral surface of lateral epicondyle) followed by home exercises. | Other | Athletic taping (AT), Kinesio tape (KT) |
| Kinesio tapingAlso: KTKinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis | Device | Kinesio tape (KT) |
| Athletic tapingAlso: ATBy athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles | Device | Athletic taping (AT) |
Primary outcome
DASH
Time frame: 30 days
The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as "without any difficulty"
4 secondary outcomes
Grip strength
Time frame: 30 days
USG examinations
Time frame: 30days
Muscle strength
Time frame: 30days
Pain intensity
Time frame: 30 days
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 13 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Tennis Elbow
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
Nilgun Bek, Proffessor study director
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening exercises, Intensive Physioytherapy and Kinesio taping in people with Tennis Elbow, run by Hacettepe University.
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 1 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
DASH (time frame: 30 days). 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 13 Dec 2016.