PRESSURE PAIN THRESHOLDNCT04263077
The Effect of Kinesio Taping Tension on the Pain Threshold and Tolerance
A study testing 50% TENSION GROUP, 75% TENSION GROUP and 100% TENSION GROUP in people with PRESSURE PAIN THRESHOLD and PAIN TOLERANCE, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of kinesiotape technique applied in different tensions on pain tolerance (PT) of healthy university students. 100 healthy and volunteer male individuals studying at Mugla Sitki Kocman University Faculty of Health Sciences will participate in the research. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PRESSURE PAIN THRESHOLD, PAIN TOLERANCE, KINESIOTAPING
- What is being tested?
- 50% TENSION GROUP, 75% TENSION GROUP and 100% TENSION GROUP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2018to 1 Aug 2020
- 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 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a male university student over the age of 18
- Volunteering for the study
- Filling out the informed consent form Not having the knowledge and experience about kinesiotaping before
Who cannot join
- Being diagnosed with lateral epicondylit and its treatment
- Having any neurological disease or systemic disease that disrupts sense / pain perception (diabetes, rheumatoid arthritis, peripheral vascular disease, etc.)
- Skin sensitivity to elastic banding
- Open wound, ulcer, fungal infection in the area to be taped
- Exposure to upper extremity and / or cervical injury in the past 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University Health Sciences Faculty
Muğla, 48000
About this study
Official title: The Effect of Kinesio Taping Tension on the Pressure-pain Threshold and Pain Tolerance: a Randomized Controlled Trial
The aim of this study was to investigate the effects of kinesiotape technique applied in different tensions on pain tolerance (PT) of healthy university students. 100 healthy and volunteer male individuals studying at Mugla Sitki Kocman University Faculty of Health Sciences will participate in the research. Study protocol was approved by the ethics committee of Mugla Sitki Kocman University. The study is designed as a randomized, controlled, double-blind study to be performed on 4 groups consisting of 25 individuals in each group (No tension(Placebo), and 50%, 75%, 100% tensions of Kinesiotape). Kinesiotape will be applied over lateral epicondyle of the dominant extremities with diamond shape technique by a KTAI®certified physiotherapist. PT's will be measured with J-Tech algometer before, immediately and 30 minutes after taping by a different physiotherapist who will be blind to taping tension.
Read the detailed description
Diamond shape banding method will be applied in a way that 4 bands of 2.5 cm width cut kinesio tape ends on top of each other, leaving the lateral epicondyle region exposed while the elbows are slightly flexed in the supine position. In the groups where different tensions will be applied, the middle points of the tapes will be stretched according to the amount of tensions, and the ends will be taped over each other without tension.In the placebo group, the tapes of the tapes will be applied tensionlessly without overlapping each other. Algometer will be used in the assessment of pressure pain threshold and pain tolerance. Pain severity felt at the level of pain threshold and pain tolerance will be evaluated with the Visual Analogue Scale (VAS). All measurements will be made before taping, immediately after taping and 30 minutes after taping, will be repeated 3 times and their average values will be recorded. There will be a 60 second rest period between each trial to avoid temporal sensitization. Each assessment will be performed bilaterally by another physiotherapist who is blind to the band tension and has no experience with the kinesio banding technique.
- Conditions
- PRESSURE PAIN THRESHOLD, PAIN TOLERANCE, KINESIOTAPING
- Being tested
- PLACEBO, 50% TENSION GROUP, 75% TENSION GROUP, 100% TENSION GROUP
- Keywords
- KINESIOTAPING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLACEBOOther
The diamond shape technique, which is a kinesio tape technique, will be used in the lateral epicondyle region. The ends of the kinesiotapes will be applied tension-free without overlapping.
50% TENSION GROUPOther
Kinesiotape will be applied to the lateral epicondyle region with 50% tension.
75% TENSION GROUPOther
Kinesiotape will be applied to the lateral epicondyle region with 75% tension.
100% TENSION GROUPOther
Kinesiotape will be applied to the lateral epicondyle region with 100% tension.
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | IN THE PLACEBO GROUP, THE ENDS OF THE TAPES WILL BE APPLIED NO TENSION WITHOUT OVERLAPPING EACH OTHER. Receives: Other: PLACEBO |
| 50% TENSION GROUP | Other | KINESIOTAPE WILL BE APPLIED WITH 50% TENSION. Receives: Other: 50% TENSION GROUP |
| 75% TENSION GROUP | Other | KINESIOTAPE WILL BE APPLIED WITH 75% TENSION. Receives: Other: 75% TENSION GROUP |
| 100% TENSION GROUP | Other | KINESIOTAPE WILL BE APPLIED WITH 100% TENSION. Receives: Other: 100% TENSION GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
Study will be performed with 4 groups of 25 individuals, each of whom use the kinesiotape at different tensions. 0% tension application will be for Placebo, 50% tension application, 75% tension application 100% tension application. In groups with different tension banding, pressure pain threshold will be measured with algometer bilaterally. Measurements will be repeated 3 times and their average will be recorded.
Measured: 10 minutes
Pain Tolerance
After measuring the pressure pain threshold, the pain tolerance of the same groups will be measured with an algometer. Measurements will be repeated 3 times and their average will be recorded.
Measured: 10 minutes
Visual Analog Scale
Pain severity felt at the level of pain threshold and pain tolerance will be evaluated with the Visual Analogue Scale (VAS) bilaterally. The pain intensity created by the algometer probe end will be measured by VAS. The patients will mark the severity of their pain on a 100 mm line, one end of which is painless and the other end expressing unbearably severe pain. Values close to 0 mean that the pain is less, and values close to 100 indicate that the pain is high.The VAS assessment will be done immediately after each pressure pain threshold and pain tolerance measurements. Measurements will be repeated 3 times and their average will be recorded.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start18 Nov 2018
- Primary completion17 Jan 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRESSURE PAIN THRESHOLDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OYKU AVCI, Muğla Sıtkı Koçman University
- Investigators
- Nazan Tuğay, PhD, Study chair, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263077
- Sponsor's protocol ID
- 180176
- Status last verified
- Oct 2022
- First submitted
- 5 Feb 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesio Taping Tension on the Pressure-pain Threshold and Pain Tolerance: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04263077
- Acronym / sponsor ID
- 180176
- Conditions
- PRESSURE PAIN THRESHOLD, PAIN TOLERANCE, KINESIOTAPING
- Keywords
- KINESIOTAPING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 10 Feb 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.
The aim of this study was to investigate the effects of kinesiotape technique applied in different tensions on pain tolerance (PT) of healthy university students. 100 healthy and volunteer male individuals studying at Mugla Sitki Kocman University Faculty of Health Sciences will participate in the research. Study protocol was approved by the ethics committee of Mugla Sitki Kocman University. The study is designed as a randomized, controlled, double-blind study to be performed on 4 groups consisting of 25 individuals in each group (No tension(Placebo), and 50%, 75%, 100% tensions of Kinesiotape). Kinesiotape will be applied over lateral epicondyle of the dominant extremities with diamond shape technique by a KTAI®certified physiotherapist. PT's will be measured with J-Tech algometer before, immediately and 30 minutes after taping by a different physiotherapist who will be blind to taping tension.
Detailed description
Diamond shape banding method will be applied in a way that 4 bands of 2.5 cm width cut kinesio tape ends on top of each other, leaving the lateral epicondyle region exposed while the elbows are slightly flexed in the supine position. In the groups where different tensions will be applied, the middle points of the tapes will be stretched according to the amount of tensions, and the ends will be taped over each other without tension.In the placebo group, the tapes of the tapes will be applied tensionlessly without overlapping each other. Algometer will be used in the assessment of pressure pain threshold and pain tolerance. Pain severity felt at the level of pain threshold and pain tolerance will be evaluated with the Visual Analogue Scale (VAS). All measurements will be made before taping, immediately after taping and 30 minutes after taping, will be repeated 3 times and their average values will be recorded. There will be a 60 second rest period between each trial to avoid temporal sensitization. Each assessment will be performed bilaterally by another physiotherapist who is blind to the band tension and has no experience with the kinesio banding technique.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Other: PLACEBOIN THE PLACEBO GROUP, THE ENDS OF THE TAPES WILL BE APPLIED NO TENSION WITHOUT OVERLAPPING EACH OTHER. |
| 50% TENSION GROUP | Other | Other: 50% TENSION GROUPKINESIOTAPE WILL BE APPLIED WITH 50% TENSION. |
| 75% TENSION GROUP | Other | Other: 75% TENSION GROUPKINESIOTAPE WILL BE APPLIED WITH 75% TENSION. |
| 100% TENSION GROUP | Other | Other: 100% TENSION GROUPKINESIOTAPE WILL BE APPLIED WITH 100% TENSION. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being a male university student over the age of 18
- Volunteering for the study
- Filling out the informed consent form Not having the knowledge and experience about kinesiotaping before
Key exclusion criteria (5 listed)
- Being diagnosed with lateral epicondylit and its treatment
- Having any neurological disease or systemic disease that disrupts sense / pain perception (diabetes, rheumatoid arthritis, peripheral vascular disease, etc.)
- Skin sensitivity to elastic banding
- Open wound, ulcer, fungal infection in the area to be taped
- Exposure to upper extremity and / or cervical injury in the past 6 months
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 |
|---|---|---|
| PLACEBOThe diamond shape technique, which is a kinesio tape technique, will be used in the lateral epicondyle region. The ends of the kinesiotapes will be applied tension-free without overlapping. | Other | PLACEBO |
| 50% TENSION GROUPKinesiotape will be applied to the lateral epicondyle region with 50% tension. | Other | 50% TENSION GROUP |
| 75% TENSION GROUPKinesiotape will be applied to the lateral epicondyle region with 75% tension. | Other | 75% TENSION GROUP |
| 100% TENSION GROUPKinesiotape will be applied to the lateral epicondyle region with 100% tension. | Other | 100% TENSION GROUP |
Primary outcome
Pressure Pain Threshold
Time frame: 10 minutes
Study will be performed with 4 groups of 25 individuals, each of whom use the kinesiotape at different tensions. 0% tension application will be for Placebo, 50% tension application, 75% tension application 100% tension application. In groups with different tension banding, pressure pain threshold will be measured with algometer bilaterally. Measurements will be repeated 3 times and their average will be recorded.
Pain Tolerance
Time frame: 10 minutes
After measuring the pressure pain threshold, the pain tolerance of the same groups will be measured with an algometer. Measurements will be repeated 3 times and their average will be recorded.
Visual Analog Scale
Time frame: 10 minutes
Pain severity felt at the level of pain threshold and pain tolerance will be evaluated with the Visual Analogue Scale (VAS) bilaterally. The pain intensity created by the algometer probe end will be measured by VAS. The patients will mark the severity of their pain on a 100 mm line, one end of which is painless and the other end expressing unbearably severe pain. Values close to 0 mean that the pain is less, and values close to 100 indicate that the pain is high.The VAS assessment will be done immediately after each pressure pain threshold and pain tolerance measurements. Measurements will be repeated 3 times and their average will be recorded.
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 4 Oct 2022.
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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.
Nazan Tuğay, PhD study chair
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% TENSION GROUP, 75% TENSION GROUP and 100% TENSION GROUP in people with PRESSURE PAIN THRESHOLD and PAIN TOLERANCE, run by Muğla Sıtkı Koçman 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 5 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 4 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Pressure Pain Threshold (time frame: 10 minutes). The study lists 3 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 4 Oct 2022.