Lateral EpicondylitisNCT04206423
Grip Strength or Pinch Strength in Lateral Epicondylitis
An observational study of Lateral Epicondylitis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Grip strength can be decreased in lateral epicondylitis. Pinch strength is also affected in people suffering from lateral epicondylitis. In this study, participants will be evaluated using a hydraulic dynamometer, a pinch meter and we will evaluate pain, disability and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 May 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Participants suffering from lateral epicondylitis will be included in the patient group and healthy control will be included in control group.
Who may be able to join
- Pain in elbow for at least two weeks
Who cannot join
- Nonsteroidal antiinflammatory drug usage during last week.
- Rheumatic diseases (Rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, etc.)
- Malignancy
- Extracorporeal shock wave therapy in last six months
- Lateral epicondylitis injection in last six months or any treatment.
- Lateral epicondylitis brace usage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul
Mehmet A Güler, Dr., +905054930098, makifguler89@gmail.com
About this study
Official title: Grip Strength or Pinch Strength: Which is Preferred to Evaluate Lateral Epicondylitis?
Grip strength can be decreased in lateral epicondylitis. Pinch strength is also affected in people suffering from lateral epicondylitis. In this study, participants will be evaluated using a hydraulic dynamometer, a pinch meter and we will evaluate pain, disability and quality of life.
Read the detailed description
Newly diagnosed patients with lateral epicondylitis and healthy controls will be included in the study with an allocation ratio of 2:1. Using a hydraulic dynamometer grip strength will be evaluated three times, one minute between each measurement. Then palmar pinch, key pinch and tip pinch measurements will be evaluated for three times each. For each measurement, the participants will rest one minute between repetitive measurements, and five minutes between each parameters. The order of measurements will be randomized for each participants to avoid bias. Then the participants will be evaluated using different scales for pain, disability and quality of life.
- Conditions
- Lateral Epicondylitis
- Keywords
- Disability evaluation, Hand Strength, Quality of life, Pain, Pinch Strength, Tennis elbow
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Age and sex matched healthy controls | |
| Lateral epicondylitis | Newly diagnosed lateral epicondylitis patients. 1. Pain in lateral epicondylitis region 2. Pain increase with palpation 3. Positivity in two diagnostic test out of three (Maudley's test, Mill's test or Cozen's test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand (grip) Strength
Maximum and Pain free hand grip strength using a handheld dynamometer
Measured: 0.day
Pinch Strength (key pinch, palmar pinch and tip pinch)
Maximum and Pain free hand grip strength using a handheld dynamometer
Measured: 0.day
Secondary outcomes (5)
Visual Analog Scale (VAS)-During day
Pain during day will be evaluated using visual analog scale
Measured: 0.day
VAS-Night
Pain during night will be evaluated using visual analog scale
Measured: 0.day
Patient Rated Tennis Elbow Evaluation Scale
The questions will help to understand the amount of difficulty the patient have had with their arm in the past week. The patient will be describing their average arm symptoms over the past week on a scale 0-10.
Measured: 0.day
Disability
The Disabilities of the Arm, Shoulder and Hand Scale
Measured: 0.day
World Health Organization-Quality of Life- Bref (WHOQOL-BREF) scale
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Measured: 0.day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jan 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ebru Y Yalcınkaya, Ass. Prof., Study chair, Gaziosmanpasa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206423
- Sponsor's protocol ID
- GaziosmanpasaTREH9
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grip Strength or Pinch Strength: Which is Preferred to Evaluate Lateral Epicondylitis?
- ClinicalTrials.gov ID
- NCT04206423
- Acronym / sponsor ID
- GaziosmanpasaTREH9
- Conditions
- Lateral Epicondylitis
- Keywords
- Disability evaluation, Hand Strength, Quality of life, Pain, Pinch Strength, Tennis elbow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 20 Dec 2019 (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.
Grip strength can be decreased in lateral epicondylitis. Pinch strength is also affected in people suffering from lateral epicondylitis. In this study, participants will be evaluated using a hydraulic dynamometer, a pinch meter and we will evaluate pain, disability and quality of life.
Detailed description
Newly diagnosed patients with lateral epicondylitis and healthy controls will be included in the study with an allocation ratio of 2:1. Using a hydraulic dynamometer grip strength will be evaluated three times, one minute between each measurement. Then palmar pinch, key pinch and tip pinch measurements will be evaluated for three times each. For each measurement, the participants will rest one minute between repetitive measurements, and five minutes between each parameters. The order of measurements will be randomized for each participants to avoid bias. Then the participants will be evaluated using different scales for pain, disability and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Age and sex matched healthy controls |
| Lateral epicondylitis | – | –Newly diagnosed lateral epicondylitis patients. 1. Pain in lateral epicondylitis region 2. Pain increase with palpation 3. Positivity in two diagnostic test out of three (Maudley's test, Mill's test or Cozen's test) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants suffering from lateral epicondylitis will be included in the patient group and healthy control will be included in control group.
Key inclusion criteria (1 listed)
- Pain in elbow for at least two weeks
Key exclusion criteria (6 listed)
- Nonsteroidal antiinflammatory drug usage during last week.
- Rheumatic diseases (Rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, etc.)
- Malignancy
- Extracorporeal shock wave therapy in last six months
- Lateral epicondylitis injection in last six months or any treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hand (grip) Strength
Time frame: 0.day
Maximum and Pain free hand grip strength using a handheld dynamometer
Pinch Strength (key pinch, palmar pinch and tip pinch)
Time frame: 0.day
Maximum and Pain free hand grip strength using a handheld dynamometer
5 secondary outcomes
Visual Analog Scale (VAS)-During day
Time frame: 0.day
VAS-Night
Time frame: 0.day
Patient Rated Tennis Elbow Evaluation Scale
Time frame: 0.day
Disability
Time frame: 0.day
World Health Organization-Quality of Life- Bref (WHOQOL-BREF) scale
Time frame: 0.day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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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.
Ebru Y Yalcınkaya, Ass. Prof. study chair
Gaziosmanpasa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis, run by Gaziosmanpasa Research and Education 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Jan 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet A Güler, M.D. (+905054930098, makifguler89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand (grip) Strength (time frame: 0.day). 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 14 Jan 2020.