Low Back PainPhase 2NCT01626482
Effect of Kinesio Tape in Muscle Fatigue Measured by Biering-Sorensen Test
A Phase 2 study testing Kinesio Taping in people with Low Back Pain, run by CEU San Pablo University at 1 site in Spain.
Trial summary
Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. However we do not know accurately the mechanisms that produce it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Kinesio Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- More than 18 years
- They were motivated to be included in the study
Who cannot join
- History of Low Back Pain (LBP) in the last 6 months that had lasted for at least 1 week and / or had required medical attention and / or had been off sick
- Back surgery
- Been diagnosed with cardiovascular disease or neurological or herniations, protrusions or severe scoliosis
- Had pain from a disease presenting infection, tumor or injury of an anatomical structure involved in the test
Trial locations and contacts
1 site in 1 country.
About this study
Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. However we do not know accurately the mechanisms that produce it.
The aim of this study is to determine the influence of the Kinesio taping (KT) application in the paravertebral muscle fatigue in a sample of healthy young subjects.
- Conditions
- Low Back Pain
- Being tested
- Kinesio Taping, Placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
Also called Bandage
The taping consisted of two strips of material in the form of "I" on both sides of the lumbar spine, from the sacroiliac joint to the ipsilateral transverse process of D12.
PlaceboOther
The placebo taping consisted of two 10 cm length strips of the same material, adhered transversely to the skin of the paravertebral muscles fibers
| Study group | Role | What they receive |
|---|---|---|
| Sham tape | Placebo comparator | Not described Receives: Other: Placebo |
| Kinesio Tape | Experimental | Not described Receives: Other: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of maintenance in the Biering-Sorensen Test
Duration in seconds of the Biering-Sorensen Test
Measured: Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626482
- Sponsor's protocol ID
- CEU-003
- Status last verified
- Jul 2013
- First submitted
- 15 Jun 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Tape in Muscle Fatigue Measured by Biering-Sorensen Test
- ClinicalTrials.gov ID
- NCT01626482
- Acronym / sponsor ID
- CEU-003
- Conditions
- Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Jun 2012 (estimated)
- 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.
Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. However we do not know accurately the mechanisms that produce it.
The aim of this study is to determine the influence of the Kinesio taping (KT) application in the paravertebral muscle fatigue in a sample of healthy young subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tape | Placebo comparator | Other: Placebo |
| Kinesio Tape | Experimental | Other: Kinesio Taping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 18 years
- They were motivated to be included in the study
Key exclusion criteria (4 listed)
- History of Low Back Pain (LBP) in the last 6 months that had lasted for at least 1 week and / or had required medical attention and / or had been off sick
- Back surgery
- Been diagnosed with cardiovascular disease or neurological or herniations, protrusions or severe scoliosis
- Had pain from a disease presenting infection, tumor or injury of an anatomical structure involved in the test
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 |
|---|---|---|
| Kinesio TapingAlso: BandageThe taping consisted of two strips of material in the form of "I" on both sides of the lumbar spine, from the sacroiliac joint to the ipsilateral transverse process of D12. | Other | Kinesio Tape |
| PlaceboThe placebo taping consisted of two 10 cm length strips of the same material, adhered transversely to the skin of the paravertebral muscles fibers | Other | Sham tape |
Primary outcome
Time of maintenance in the Biering-Sorensen Test
Time frame: Seconds
Duration in seconds of the Biering-Sorensen Test
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 31 Jul 2013.
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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.
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 Phase 2 study testing Kinesio Taping in people with Low Back Pain, run by CEU San Pablo University at 1 site in Spain.
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 2 inclusion and 4 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 31 Jul 2013. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time of maintenance in the Biering-Sorensen Test (time frame: Seconds). 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 31 Jul 2013.