- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206423
Grip Strength or Pinch Strength in Lateral Epicondylitis
January 12, 2020 updated by: Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Recruiting
- Gaziosmanpasa Taksim Research and Education Hospital
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Contact:
- Mehmet A Güler, Dr.
- Phone Number: +905054930098
- Email: makifguler89@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants suffering from lateral epicondylitis will be included in the patient group and healthy control will be included in control group.
Description
Inclusion Criteria:
- Pain in elbow for at least two weeks
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Healthy Controls
Age and sex matched healthy controls
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Lateral epicondylitis
Newly diagnosed lateral epicondylitis patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand (grip) Strength
Time Frame: 0.day
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Maximum and Pain free hand grip strength using a handheld dynamometer
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0.day
|
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Pinch Strength (key pinch, palmar pinch and tip pinch)
Time Frame: 0.day
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Maximum and Pain free hand grip strength using a handheld dynamometer
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0.day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)-During day
Time Frame: 0.day
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Pain during day will be evaluated using visual analog scale
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0.day
|
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VAS-Night
Time Frame: 0.day
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Pain during night will be evaluated using visual analog scale
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0.day
|
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Patient Rated Tennis Elbow Evaluation Scale
Time Frame: 0.day
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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.
|
0.day
|
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Disability
Time Frame: 0.day
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The Disabilities of the Arm, Shoulder and Hand Scale
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0.day
|
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World Health Organization-Quality of Life- Bref (WHOQOL-BREF) scale
Time Frame: 0.day
|
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
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0.day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ebru Y Yalcınkaya, Ass. Prof., Gaziosmanpasa Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 20, 2019
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 12, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREH9
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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