Low Back PainNCT02550457
Kinesio Taping on Chronic Nonspecific Low Back Pain
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 propose analyze the effects of Kinesio Taping® in chronic nonspecific low back pain. All the subjects will be submitted to an evaluation of the painful sensation, functional performance, trunk range of motion and neuromuscular performance at three different times. 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?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Mar 2017
- 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
Universidade Federal do Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970
About this study
Official title: Effects of Kinesio Taping on Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back pain. All the subjects will be submitted to an evaluation of the painful sensation, functional performance, trunk range of motion and neuromuscular performance at three different times.
- Conditions
- Low Back Pain
- Being tested
- Functional elastic tape tensioned, Functional elastic tape non-tensioned, Rigid Tape
- 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 |
| Placebo group | Placebo comparator | 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.
Painful sensation
Pain sensation measured by pain numerical rating scale
Measured: Evaluation of pain sensation three 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 posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 108 participants (actual)
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
- NCT02550457
- Sponsor's protocol ID
- 056666/2015
- Status last verified
- May 2018
- First submitted
- 11 Sep 2015
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Macedo LB, Richards J, Borges DT, Melo SA, Brasileiro JS. Kinesio Taping reduces pain and improves disability in low back pain patients: a randomised controlled trial. Physiotherapy. 2019 Mar;105(1):65-75. doi: 10.1016/j.physio.2018.07.005. Epub 2018 Jul 26.
PubMed 30348455
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping on Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02550457
- Acronym / sponsor ID
- 056666/2015
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Sep 2015 (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.
This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back pain. All the subjects will be submitted to an evaluation of the painful sensation, functional performance, trunk range of motion and neuromuscular performance at three different times.
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. |
| Placebo group | Placebo comparator | 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 | Placebo group |
Primary outcome
Painful sensation
Time frame: Evaluation of pain sensation three days after the application of the tape.
Pain sensation measured by pain numerical rating scale
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 8 May 2018.
- Derived from this study: PubMed 30348455Macedo LB, Richards J, Borges DT, Melo SA, Brasileiro JS. Kinesio Taping reduces pain and improves disability in low back pain patients: a randomised controlled trial. Physiotherapy. 2019 Mar;105(1):65-75. doi: 10.1016/j.physio.2018.07.005. Epub 2018 Jul 26.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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 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: finished, as of the sponsor's last update on 8 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. 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?
Painful sensation (time frame: Evaluation of pain sensation 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?
On the ClinicalTrials.gov record for NCT02550457, which also lists 1 linked publication.
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 8 May 2018.