Tennis ElbowNCT02930304
Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial
A study testing first physiotherapy, second physiotherapy and third physiotherapy in people with Tennis Elbow, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- first physiotherapy, second physiotherapy and third physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Dec 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with tennis elbow,
- and the duration of symptoms was between 8 and 10 weeks,
- and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors.
- Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study
Who cannot join
- patients with 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 adhesive tape,
- and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation
Ankara, 06100
About this study
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi.
The aim of this study is to The compare the short-term effects of different physiotherapy approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.
Read the detailed description
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. Different treatment approaches are described in the literature. The primary aim of the treatment approaches are decrease the pain and improve the functional level in patients with lateral epicondylitis. Thus, decreasing pain and regaining the functional performance in the daily living activity is essential in early diagnosed patients.
The aim of this study is to compare the short-term effects of different treatment approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.
- Conditions
- Tennis Elbow
- Being tested
- first physiotherapy, second physiotherapy, third physiotherapy
- Keywords
- tennis elbow, pain, shock wave, kinesio taping
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first physiotherapyOther
Also called physiotherapy
physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions
second physiotherapyOther
Also called kinesiotaping
physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy
third physiotherapyOther
Also called Extracorporeal shockwave therapy (ESWT)
physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session.
| Study group | Role | What they receive |
|---|---|---|
| first physiotherapy | Experimental | cold pack, TENS, exercise Receives: Other: first physiotherapy |
| second physiotherapy | Experimental | cold pack, TENS, exercise, kinesiotaping Receives: Other: second physiotherapy |
| third physiotherapy | Experimental | cold pack, TENS, ESWT, exercise Receives: Other: third physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment
pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline and at the end of the three week treatment sessions
Measured: from baseline to third week after treatment sessions
Secondary outcomes (2)
functional assessment
functional status will be assessed by using Patient-Rated Tennis Elbow Evaluation Scale (PRTEE). All assessment will be recorded at baseline and at the end of the three week treatment sessions
Measured: from baseline to third week after treatment sessions
maximum grip strength evaluation
maximum grip strength will be assessed with hand dynamometer both elbow flexion and extension position. All assessment will be recorded at baseline and at the end of the three week treatment sessions
Measured: from baseline to third week after treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Eraslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930304
- Sponsor's protocol ID
- GO13/493
- Status last verified
- Apr 2018
- First submitted
- 2 Oct 2016
- Last updated
- 12 Apr 2018
- 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 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02930304
- Acronym / sponsor ID
- GO13/493
- Conditions
- Tennis Elbow
- Keywords
- tennis elbow, pain, shock wave, kinesio taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Oct 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.
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi.
The aim of this study is to The compare the short-term effects of different physiotherapy approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.
Detailed description
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. Different treatment approaches are described in the literature. The primary aim of the treatment approaches are decrease the pain and improve the functional level in patients with lateral epicondylitis. Thus, decreasing pain and regaining the functional performance in the daily living activity is essential in early diagnosed patients.
The aim of this study is to compare the short-term effects of different treatment approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| first physiotherapy | Experimental | Other: first physiotherapycold pack, TENS, exercise |
| second physiotherapy | Experimental | Other: second physiotherapycold pack, TENS, exercise, kinesiotaping |
| third physiotherapy | Experimental | Other: third physiotherapycold pack, TENS, ESWT, exercise |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with tennis elbow,
- and the duration of symptoms was between 8 and 10 weeks,
- and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors.
- Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study
Key exclusion criteria (3 listed)
- patients with 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 adhesive tape,
- and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months
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 |
|---|---|---|
| first physiotherapyAlso: physiotherapyphysiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions | Other | first physiotherapy |
| second physiotherapyAlso: kinesiotapingphysiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy | Other | second physiotherapy |
| third physiotherapyAlso: Extracorporeal shockwave therapy (ESWT)physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session. | Other | third physiotherapy |
Primary outcome
pain assessment
Time frame: from baseline to third week after treatment sessions
pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline and at the end of the three week treatment sessions
2 secondary outcomes
functional assessment
Time frame: from baseline to third week after treatment sessions
maximum grip strength evaluation
Time frame: from baseline to third week after treatment sessions
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 Apr 2018.
- Individual participant dataSharing planned: No
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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 first physiotherapy, second physiotherapy and third physiotherapy in people with Tennis Elbow, run by Hacettepe 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 4 inclusion and 3 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 Apr 2018. 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?
pain assessment (time frame: from baseline to third week after treatment sessions). 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 Apr 2018.