Lateral EpicondylitisNCT04536948
Cold Application in Lateral Epicondylitis
A study testing Cooling Gel and Cold Pack in people with Lateral Epicondylitis, run by Baskent University at 1 site in Turkey (Türkiye).
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)… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Cooling Gel and Cold Pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2016to 1 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with elbow pain for at least 3 months
- those between 20 and 40 years of age
- who did not have cold allergies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Cold Application is More Effective in Patients With 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).
- Conditions
- Lateral Epicondylitis
- Being tested
- Cooling Gel, Cold Pack
- Keywords
- Kinesio Tape, Thermal Analysis, Cold
- Medical subject headings
- Tennis Elbow, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling GelOther
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 PackOther
Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Cooling gel application Receives: Other: Cooling Gel |
| Group 2 | Active comparator | Cold pack was applied Receives: Other: Cold Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Mar 2016
- Primary completion1 May 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536948
- Sponsor's protocol ID
- KA16 / 369
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Cold Application is More Effective in Patients With Lateral Epicondylitis?
- ClinicalTrials.gov ID
- NCT04536948
- Acronym / sponsor ID
- KA16 / 369
- Conditions
- Lateral Epicondylitis
- Keywords
- Kinesio Tape, Thermal Analysis, Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Cooling GelCooling gel application |
| Group 2 | Active comparator | Other: Cold PackCold pack was applied |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with elbow pain for at least 3 months
- those between 20 and 40 years of age
- who did not have cold allergies
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling GelCooling 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 | Other | Group 1 |
| Cold PackCold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle. | Other | Group 2 |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling Gel and Cold Pack in people with Lateral Epicondylitis, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.