Cold Application in Lateral Epicondylitis

NCT04536948 | Completed

• 1 other identifier: KA16 / 369
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Lateral Epicondylitis

Keywords

Kinesio Tape; Thermal Analysis; Cold

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Cooling gel application

Other: Cooling Gel

Group 2

ACTIVE COMPARATOR

Cold pack was applied

Other: Cold Pack

Interventions

Cooling Gel OTHER

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

Group 1

Cold Pack OTHER

Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.

Group 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with elbow pain for at least 3 months
• those between 20 and 40 years of age
• who did not have cold allergies

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow; Common Cold

Interventions

methyl salicylate

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

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

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)