- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536948
Cold Application in Lateral Epicondylitis
August 28, 2020 updated by: Nihan Ozunlu Pekyavas, Baskent University
Which Cold Application is More Effective in Patients With Lateral Epicondylitis?
Purpose: The purpose of this study was to investigate which cold application is more effective to regulate skin temperature in patients with lateral epicondylitis.
Materials and Methods: Fifty-four patients with lateral epicondylitis were randomly divided into 2 groups as cooling gel (n=27) group and cold pack (n=27) group.
Cooling gel and cold pack applications were applied on painful lateral epicondyle region for 15 minutes.
Patients were assessed before and after the application.
Assessments included the severity of pain during wrist extension, evaluated by Visual Analog Scale (VAS) and thermal imaging of lateral epicondyle region evaluated by Infrared Thermography (FLIR5 Thermal Camera).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
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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Ankara, Turkey, 06790
- Başkent University
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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
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with elbow pain for at least 3 months
- those between 20 and 40 years of age
- who did not have cold allergies
Exclusion Criteria:
- With a different elbow problem or multiple elbow problems,
- having cervical or other upper extremity problems,
- elbow joint operation,
- tendon rupture,
- limited range of motion due to humerus, radius or ulna fracture
- individuals with a history of osteoporosis, malignancy, hemophilia, neurological effect, and cognitive dysfunction
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Cooling gel application
|
Cooling gel (Nelsons Arnicare Arnica Cooling Gel) was applied to the lateral epicondyle region with sponge head 3 times a day.
The cooling gel was applied to the painful area around the lateral epicondyle
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Active Comparator: Group 2
Cold pack was applied
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Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity
Time Frame: 15 minutes
|
The severity of shoulder pain at rest, night and activity was evaluated by Visual Analogue Scale (VAS).
Accordingly, in a line of 10 cm 0 point refers to no pain, 10 point was considered to be the maximum value of pain.
Patients were asked to mark the severity of their pain and tape measurement was recorded in cm.
|
15 minutes
|
Thermographic Assessment
Time Frame: 15 minutes
|
Infrared thermography (IRT) uses a thermal camera that receives and processes the infrared radiation emitted from the surface of the body.
Thus, IRT records the temperature distribution of the skin.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 3, 2020
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA16 / 369
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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