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CompletedNCT04536948Updated Sep 3, 2020

Cold Application in Lateral Epicondylitis

An interventional study of Cooling Gel and Cold Pack in Lateral Epicondylitis, sponsored by Baskent University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Baskent University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Mar 2016, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Lateral Epicondylitis

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Keywords

  • Kinesio Tape
  • Thermal Analysis
  • Cold
03

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's enrollment of 54 is close to the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Baskent University is the lead sponsor of 201 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Group 1

    Cooling gel application

    Other: Cooling Gel

  • Active comparator
    Group 2

    Cold pack was applied

    Other: Cold Pack

Interventions

  • OtherCooling 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

  • OtherCold 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 minutes

  2. 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.

    Time frame: 15 minutes

07

Study locations

1 site
  • Baskent University
    Ankara, 06790, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04536948
Lead sponsor
Baskent University
Responsible party
Nihan Ozunlu Pekyavas (Associated Proffesor, Baskent University) — Principal investigator
First posted
Sep 3, 2020
Start date
Mar 1, 2016
Primary completion
May 1, 2016
Completion
Aug 1, 2016
Last update
Sep 3, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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