Cold Application in Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

Which Cold Application is More Effective in Patients With Lateral Epicondylitis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536948
• Other study ID #: KA16 / 369
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: August 1, 2016

Study information

• Verified date: August 2020
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Other:
• Cooling Gel
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
• Cold Pack
Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes
Primary	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.	15 minutes