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Completed

NCT Number: NCT04536948

Cold Application in 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).

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Common Cold Elbow Injuries Elbow Tendinopathy Infections Muscular Diseases Musculoskeletal Diseases Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tendinopathy Tendon Injuries Tennis Elbow Virus Diseases Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Ankara, 06790, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2020
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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