Cold Application in Lateral Epicondylitis

Sponsor

Baskent University (Other)

Overall Status

Completed

CT.gov ID

NCT04536948

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lateral Epicondylitis	Other: Cooling Gel Other: Cold Pack	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Cooling gel application	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
Active Comparator: Group 2 Cold pack was applied	Other: 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.

Arm

Intervention/Treatment

Experimental: Group 1

Cooling gel application

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

Active Comparator: Group 2

Cold pack was applied

Other: 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.

Outcome Measures

Primary Outcome Measures

Pain Severity [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.
Thermographic Assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University	Ankara		Turkey	06790

Sponsors and Collaborators

Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nihan Ozunlu Pekyavas, Associated Proffesor, Baskent University

ClinicalTrials.gov Identifier:

NCT04536948

Other Study ID Numbers:

KA16 / 369

First Posted:

Sep 3, 2020

Last Update Posted:

Sep 3, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nihan Ozunlu Pekyavas, Associated Proffesor, Baskent University

Kinesio Tape

Thermal Analysis

Cold

Additional relevant MeSH terms:

Tennis Elbow

Methyl salicylate

Study Results

No Results Posted as of Sep 3, 2020