Chronic Low Back PainNCT02759757
Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain?
A study testing Kinesio Taping in people with Chronic Low Back Pain, run by Leandro Pires.
Trial summary
Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain. Study design: Three-arm, randomized controlled trial with a blinded assessor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Kinesio Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain.
Who cannot join
- patients who have used the Kinesio Taping previously
- any contraindications to the use of Kinesio Tex Gold®, such as allergy or severe skin problems.
- patients with nerve root compromise
- patients with fracture, tumor, inflammatory and/or infectious diseases
- patients with severe cardiorespiratory and/or metabolic diseases
- previous spinal surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain? A Controlled Randomized Trial
Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.
Study design: Three-arm, randomized controlled trial with a blinded assessor.
Read more
Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)
Patients: Sixty-three patients with chronic nonspecific low back pain.
Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as described by the manufacturer's manual. The patients assigned to the placebo group will receive a Micropore tape and the control group will not receive any intervention. All groups will be assessed before and 30 minutes after intervention
Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.
Limitations: Therapists will not be blinded.
Read the detailed description
Patients who are seeking care for low back pain at the physiotherapy clinic from Universidade São Paulo will be invited to participate in the study and informed about the objectives of the study and evaluation procedures.
Patients who agree to participate will sign a consent form.
Patients will be assessed at baseline and immediately after the interventions.
Investigators will collect data with regards to personal and anthropometric data, as well as pain intensity (measured by a 0-10 numerical rating scale in all follow up points) and disability (measured by the 0-24 point Roland Morris Disability Questionnaire at baseline only).
Finally, muscle activation will be evaluated by surface electromyography and the maximum voluntary contraction of the trunk at 30 degrees position for a lumbar dynamometer that will be adjusted to the anthropometric profile of patients. The average and maximum values of muscular strength will be obtained by maximum voluntary contraction. The electromyography will capture the muscle activity in an integrated manner to electrogoniometers and will transmit the data via Bluetooth to a desktop with a MWX8 software (Biometrics) that will analyze the data. Before instrumentation patients will be instructed to perform the trunk extension movement the therapist's commands to become familiar with the equipment. Soon after will be held instrumentation (placement of electromyography electrodes and electrogoniometers and lumbar dynamometer) maximal voluntary contraction will be collected in trunk extension without Kinesio taping
- Conditions
- Chronic Low Back Pain
- Being tested
- Kinesio Taping, Placebo
- Keywords
- Kinesio Taping, Low back Pain, Electromyographic, EMG
- 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 Kinesiology tape, Kinesio tape, Kinesiotaping
This is a tape that can be placed in different parts of the body using different shapes and tensions. In theory, this tape can change muscle activity.
PlaceboOther
A micropore tape will be used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping | Experimental | Patients from this group will receive the kinesio Taping® Tex Gold tape according to the manufacturer's instructions. Kinesio Taping will be applied for the purpose of inhibiting the erector spinal muscle from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae with 10 to 15% tension (paper-OFF) in a "I" position bilaterally. Receives: Other: Kinesio Taping |
| Placebo | Placebo comparator | Patient from this group will receive a 5cm-wide Micropore® tape from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae bilaterally. Receives: Other: Placebo |
| Control | No intervention | Patients allocated will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Force
Median force (a measure of muscle activity) will be collected using surface electromyography.
Measured: thirty minutes after interventions
Root Mean Square
Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.
Measured: thirty minutes after interventions
Secondary outcomes (1)
Pain Intensity
This outcome will be measured using a 0-10 numerical rating scale ranging from "no pain" to "worse possible pain".
Measured: thirty minutes after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
- Study completionFeb 2017 (estimated)
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 Chronic 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leandro Pires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leandro Pires, Universidade Cidade de Sao Paulo
- Investigators
- Leonardo OP Costa, PhD, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759757
- Sponsor's protocol ID
- pires1904
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Pires LG, Padula RS, Junior MADL, Santos I, Almeida MO, Tomazoni SS, Costa LCM, Costa LOP. Can Kinesio Taping(R) influence the electromyographic signal intensity of trunk extensor muscles in patients with chronic low back pain? A randomized controlled trial. Braz J Phys Ther. 2020 Nov-Dec;24(6):539-549. doi: 10.1016/j.bjpt.2019.12.001. Epub 2019 Dec 15.
PubMed 31866161
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain? A Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT02759757
- Acronym / sponsor ID
- pires1904
- Conditions
- Chronic Low Back Pain
- Keywords
- Kinesio Taping, Low back Pain, Electromyographic, EMG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Leandro PiresUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 3 May 2016 (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.
Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain.
Study design: Three-arm, randomized controlled trial with a blinded assessor.
Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID)
Patients: Sixty-three patients with chronic nonspecific low back pain.
Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as described by the manufacturer's manual. The patients assigned to the placebo group will receive a Micropore tape and the control group will not receive any intervention. All groups will be assessed before and 30 minutes after intervention
Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity.
Limitations: Therapists will not be blinded.
Detailed description
Patients who are seeking care for low back pain at the physiotherapy clinic from Universidade São Paulo will be invited to participate in the study and informed about the objectives of the study and evaluation procedures.
Patients who agree to participate will sign a consent form.
Patients will be assessed at baseline and immediately after the interventions.
Investigators will collect data with regards to personal and anthropometric data, as well as pain intensity (measured by a 0-10 numerical rating scale in all follow up points) and disability (measured by the 0-24 point Roland Morris Disability Questionnaire at baseline only).
Finally, muscle activation will be evaluated by surface electromyography and the maximum voluntary contraction of the trunk at 30 degrees position for a lumbar dynamometer that will be adjusted to the anthropometric profile of patients. The average and maximum values of muscular strength will be obtained by maximum voluntary contraction. The electromyography will capture the muscle activity in an integrated manner to electrogoniometers and will transmit the data via Bluetooth to a desktop with a MWX8 software (Biometrics) that will analyze the data. Before instrumentation patients will be instructed to perform the trunk extension movement the therapist's commands to become familiar with the equipment. Soon after will be held instrumentation (placement of electromyography electrodes and electrogoniometers and lumbar dynamometer) maximal voluntary contraction will be collected in trunk extension without Kinesio taping
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Experimental | Other: Kinesio TapingPatients from this group will receive the kinesio Taping® Tex Gold tape according to the manufacturer's instructions. Kinesio Taping will be applied for the purpose of inhibiting the erector spinal muscle from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae with 10 to 15% tension (paper-OFF) in a "I" position bilaterally. |
| Placebo | Placebo comparator | Other: PlaceboPatient from this group will receive a 5cm-wide Micropore® tape from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae bilaterally. |
| Control | No intervention | –Patients allocated will not receive any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain.
Key exclusion criteria (6 listed)
- patients who have used the Kinesio Taping previously
- any contraindications to the use of Kinesio Tex Gold®, such as allergy or severe skin problems.
- patients with nerve root compromise
- patients with fracture, tumor, inflammatory and/or infectious diseases
- patients with severe cardiorespiratory and/or metabolic diseases
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: Kinesiology tape, Kinesio tape, KinesiotapingThis is a tape that can be placed in different parts of the body using different shapes and tensions. In theory, this tape can change muscle activity. | Other | Kinesio Taping |
| PlaceboA micropore tape will be used as placebo | Other | Placebo |
Primary outcome
Median Force
Time frame: thirty minutes after interventions
Median force (a measure of muscle activity) will be collected using surface electromyography.
Root Mean Square
Time frame: thirty minutes after interventions
Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.
1 secondary outcome
Pain Intensity
Time frame: thirty minutes after interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Derived from this study: PubMed 31866161Pires LG, Padula RS, Junior MADL, Santos I, Almeida MO, Tomazoni SS, Costa LCM, Costa LOP. Can Kinesio Taping(R) influence the electromyographic signal intensity of trunk extensor muscles in patients with chronic low back pain? A randomized controlled trial. Braz J Phys Ther. 2020 Nov-Dec;24(6):539-549. doi: 10.1016/j.bjpt.2019.12.001. Epub 2019 Dec 15.
- Individual participant dataSharing planned: Undecided
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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.
Leonardo OP Costa, PhD principal investigator
Universidade Cidade de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping in people with Chronic Low Back Pain, run by Leandro Pires.
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 6 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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo OP Costa, PhD (+551121781564, Leonardo.costa@unicid.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Force (time frame: thirty minutes after interventions). The study lists 2 primary outcomes in all. 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 NCT02759757, 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 3 May 2016.