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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04206423
Other study ID # GaziosmanpasaTREH9
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date May 1, 2020

Study information

Verified date January 2020
Source Gaziosmanpasa Taksim Research and Education Hospital
Contact Mehmet A Güler, M.D.
Phone +905054930098
Email makifguler89@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gaziosmanpasa Taksim Research and Education Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hand (grip) Strength Maximum and Pain free hand grip strength using a handheld dynamometer 0.day
Primary Pinch Strength (key pinch, palmar pinch and tip pinch) Maximum and Pain free hand grip strength using a handheld dynamometer 0.day
Secondary Visual Analog Scale (VAS)-During day Pain during day will be evaluated using visual analog scale 0.day
Secondary VAS-Night Pain during night will be evaluated using visual analog scale 0.day
Secondary 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. 0.day
Secondary Disability The Disabilities of the Arm, Shoulder and Hand Scale 0.day
Secondary 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. 0.day
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