Low Back PainNCT03463200
KT on Low Back Pain Patients
A study testing Functional elastic tape tensioned, Functional elastic tape non-tensioned and Rigid Tape in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back pain patients, analysing the electromyography activity of longissimus muscle (median frequency) and the sustained time during a fatigue test (Ito test). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Functional elastic tape tensioned, Functional elastic tape non-tensioned and Rigid Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2018to Jun 2018
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.
Who cannot join
- Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
- Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
- Fibromyalgia
- Corticosteroid treatment in the previous two weeks;
- Antiinflammatory treatment in the previous 24 hours;
- Contraindications to the use of Kinesio Taping (allergy or intolerance);
Show all 9Show fewer
- Score of two or less on Visual Analogue Scale of the first day;
- Pregnancy;
- Previous Kinesio Tape therapy on lumbar.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59140-840
Jamilson S Brasileiro, PhD, +55 84 3342-2008, brasileiro@ufrnet.br
About this study
Official title: The Influence of Kinesio Taping on Back Muscle Fatigue of Low Back Pain Patients
This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back pain patients, analysing the electromyography activity of longissimus muscle (median frequency) and the sustained time during a fatigue test (Ito test).
Read the detailed description
Individuals with low back pain usually have poor back muscles endurance, which may be improved with the application of Kinesio Taping. The aim of this study is evaluate the effect of Kinesio Taping on back muscle fatigue of low back pain patients. Sixty-four women, between 18 to 50 years old, with chronic nonspecific Low Back Pain will attend this study. They will be randomly assigned in four different groups: control group (CG), KT with tension group (KTT), KT no tension group (KTNT) and Micropore® group (MP) and submitted to three evaluations: pre, three and ten days after intervention, analysing the electromyography activity of longissimus muscle and the sustained time during a fatigue test. The variables analysed during the evaluations will be median frequency (MP) slope of longuissimus muscle and sustained time during the Ito test.
- Conditions
- Low Back Pain
- Being tested
- Functional elastic tape tensioned, Functional elastic tape non-tensioned, Rigid Tape
- Keywords
- bandage, low back pain, muscle fatigue, electromyography
- 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.
Functional elastic tape tensionedOther
Also called Kinesio Taping with tension
Application of Kinesio Taping with tension in the erector spine muscles.
Functional elastic tape non-tensionedOther
Also called Kinesio Taping without tension
Application of Kinesio Taping without tension in the erector spine muscles.
Rigid TapeOther
Also called Micropore Tape
Application of Micropore tape in the erector spine muscles.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | It will not apply any tape. |
| Experimental group 1 | Experimental | Apply the KT with tension in the erector spine muscles. Receives: Other: Functional elastic tape tensioned |
| Experimental group 2 | Experimental | Apply the KT without tension in the erector spine muscles. Receives: Other: Functional elastic tape non-tensioned |
| Experimental group 3 | Experimental | Apply Micropore tape in the erector spine muscles. Receives: Other: Rigid Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median frequency
Median frequency slope measured my electromyography
Measured: Change from baseline median frequency at three days after the application of the tape.
Secondary outcomes (3)
Median frequency
Median frequency slope measured my electromyography
Measured: Change from baseline median frequency at ten days after the application of the tape.
Sustained muscle fatigue time
Sustained time during a fatigue test
Measured: Change from baseline sustained time at three days after the application of the tape.
Sustained muscle fatigue time
Sustained time during a fatigue test
Measured: Change from baseline sustained time at ten days after the application of the tape.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start5 Mar 2018
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463200
- Sponsor's protocol ID
- LBM2018
- Status last verified
- May 2018
- First submitted
- 5 Mar 2018
- Last updated
- 4 May 2018
- 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 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Kinesio Taping on Back Muscle Fatigue of Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03463200
- Acronym / sponsor ID
- LBM2018
- Conditions
- Low Back Pain
- Keywords
- bandage, low back pain, muscle fatigue, electromyography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Mar 2018 (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.
This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back pain patients, analysing the electromyography activity of longissimus muscle (median frequency) and the sustained time during a fatigue test (Ito test).
Detailed description
Individuals with low back pain usually have poor back muscles endurance, which may be improved with the application of Kinesio Taping. The aim of this study is evaluate the effect of Kinesio Taping on back muscle fatigue of low back pain patients. Sixty-four women, between 18 to 50 years old, with chronic nonspecific Low Back Pain will attend this study. They will be randomly assigned in four different groups: control group (CG), KT with tension group (KTT), KT no tension group (KTNT) and Micropore® group (MP) and submitted to three evaluations: pre, three and ten days after intervention, analysing the electromyography activity of longissimus muscle and the sustained time during a fatigue test. The variables analysed during the evaluations will be median frequency (MP) slope of longuissimus muscle and sustained time during the Ito test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –It will not apply any tape. |
| Experimental group 1 | Experimental | Other: Functional elastic tape tensionedApply the KT with tension in the erector spine muscles. |
| Experimental group 2 | Experimental | Other: Functional elastic tape non-tensionedApply the KT without tension in the erector spine muscles. |
| Experimental group 3 | Experimental | Other: Rigid TapeApply Micropore tape in the erector spine muscles. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.
Key exclusion criteria (9 listed)
- Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
- Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
- Fibromyalgia
- Corticosteroid treatment in the previous two weeks;
- Antiinflammatory treatment in the previous 24 hours;
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 |
|---|---|---|
| Functional elastic tape tensionedAlso: Kinesio Taping with tensionApplication of Kinesio Taping with tension in the erector spine muscles. | Other | Experimental group 1 |
| Functional elastic tape non-tensionedAlso: Kinesio Taping without tensionApplication of Kinesio Taping without tension in the erector spine muscles. | Other | Experimental group 2 |
| Rigid TapeAlso: Micropore TapeApplication of Micropore tape in the erector spine muscles. | Other | Experimental group 3 |
Primary outcome
Median frequency
Time frame: Change from baseline median frequency at three days after the application of the tape.
Median frequency slope measured my electromyography
3 secondary outcomes
Median frequency
Time frame: Change from baseline median frequency at ten days after the application of the tape.
Sustained muscle fatigue time
Time frame: Change from baseline sustained time at three days after the application of the tape.
Sustained muscle fatigue time
Time frame: Change from baseline sustained time at ten days after the application of the tape.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional elastic tape tensioned, Functional elastic tape non-tensioned and Rigid Tape in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 May 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamilson S Brasileiro, Professor (+55 84 3342-2015, brasileiro@ufrnet.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median frequency (time frame: Change from baseline median frequency at three days after the application of the tape.). 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 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.