Low Back PainNCT02007668
Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain?
A study testing Kinesio Taping in people with Low Back Pain, run by Paulista University at 1 site in Brazil.
Trial summary
Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive the correct application of the method described. The placebo group will receive a medical adhesive tape. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Nov 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-specific low back pain longer than 3 months
- Seeking care for low back pain
Who cannot join
- Contra indications to any bandage
- Serious sinal pathologies (e.g. tumors, fractures and inflammatory diseases)
- Nerve roto compromise
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain? A Randomized Controlled Trial
Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive the correct application of the method described. The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.
Read the detailed description
The group Kinesio taping receive the correct application of the method described with tension paper off (10-15%). The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.
- Conditions
- Low Back Pain
- Being tested
- Kinesio Taping
- Keywords
- low back pain, kinesio taping
- 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 -Bandages, -Tape, -Taping, -Kinesio Tex
Kinesio taping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping | Experimental | Patients will receive an application of Kinesio taping in their lumbar spine. Receives: Other: Kinesio Taping |
| Kinesio Taping Placebo | Placebo comparator | Patients will receive an application of medical adhesive tape in their lumbar spine. |
| Control | No intervention | This participants will not receive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain Intensity will be measured in 2 and 7 days after randomization by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Measured: 2 days
Secondary outcomes (1)
Disability
Disability associated with low back pain will be measured in 2 and 7 days after randomization by the 24-item Roland Morris Disability Questionnaire
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionNov 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Antonio da Luz Junior, Paulista University
- Investigators
- Mauricio Antonio da Luz Junior, MSc, Principal investigator, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007668
- Sponsor's protocol ID
- CAAE:16832013.9.0000.5512
- Status last verified
- Dec 2013
- First submitted
- 30 Nov 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02007668
- Acronym / sponsor ID
- CAAE:16832013.9.0000.5512
- Conditions
- Low Back Pain
- Keywords
- low back pain, kinesio taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Dec 2013 (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.
Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive the correct application of the method described. The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.
Detailed description
The group Kinesio taping receive the correct application of the method described with tension paper off (10-15%). The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Experimental | Other: Kinesio TapingPatients will receive an application of Kinesio taping in their lumbar spine. |
| Kinesio Taping Placebo | Placebo comparator | –Patients will receive an application of medical adhesive tape in their lumbar spine. |
| Control | No intervention | –This participants will not receive intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with non-specific low back pain longer than 3 months
- Seeking care for low back pain
Key exclusion criteria (4 listed)
- Contra indications to any bandage
- Serious sinal pathologies (e.g. tumors, fractures and inflammatory diseases)
- Nerve roto compromise
- Pregnancy
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: -Bandages, -Tape, -Taping, -Kinesio TexKinesio taping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the lumbar spine. | Other | Kinesio Taping |
Primary outcome
Pain Intensity
Time frame: 2 days
Pain Intensity will be measured in 2 and 7 days after randomization by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
1 secondary outcome
Disability
Time frame: 2 days
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 11 Dec 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.
Mauricio Antonio da Luz Junior, MSc principal investigator
Paulista 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 Kinesio Taping in people with Low Back Pain, run by Paulista University at 1 site in Brazil.
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 11 Dec 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 Brazil. 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?
Pain Intensity (time frame: 2 days). 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 11 Dec 2013.