Back to resultsCold Application in Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cooling Gel
Cold Pack
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Kinesio Tape, Thermal Analysis, Cold
Eligibility Criteria
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
Sites / Locations
- Baskent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Cooling gel application
Cold pack was applied
Outcomes
Primary Outcome Measures
Pain Severity
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.
Thermographic Assessment
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04536948
Brief Title
Cold Application in Lateral Epicondylitis
Official Title
Which Cold Application is More Effective in Patients With Lateral Epicondylitis?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Kinesio Tape, Thermal Analysis, Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Cooling gel application
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Cold pack was applied
Intervention Type
Other
Intervention Name(s)
Cooling Gel
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cold Pack
Intervention Description
Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.
Primary Outcome Measure Information:
Title
Pain Severity
Description
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.
Time Frame
15 minutes
Title
Thermographic Assessment
Description
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.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06790
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cold Application in Lateral Epicondylitis
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