Chronic Low Back PainKITALONCT02604290
Kinesio Taping Efficacy in Chronic Low Back Pain Treatment (KITALO)
A study testing Kinesio Taping method in people with Chronic Low Back Pain, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether the kinesio taping method is effective in the treatment of chronic (more than six months duration) low back pain. 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 method
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2015to 14 Nov 2016
- 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
- Age between 18 and 65 years.
- Chronic low back pain least 6 months duration.
- Improvement of pain with mobilization of skin/fascias in physical examination.
- Signature of informed consent.
Who cannot join
- Having had previous treatment experience with kinesio taping method.
- Presence of components of neuropathic pain (radiculopathy, lumbar canal stenosis).
- Specific origin pain (vertebral fracture, tumor or nerve column structures, spondyloarthropathy, spondylodiscitis).
- Prior spine surgery.
- Mental retardation, severe mental illness, substance abuse or dependency, illiteracy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinesio Taping Method for Chronic Mechanical Low Back Pain: a Randomised Controlled Trial
The purpose of this study is to determine whether the kinesio taping method is effective in the treatment of chronic (more than six months duration) low back pain.
Read the detailed description
Hypothesis: Kinesio taping treatment in patients with chronic low back pain, in which fascial mobilisation represents a treatment effect modifier, reduces pain and disability and improves quality of live, in comparison with simulated kinesio taping.
Objective:
- Primary objective: To evaluate kinesio taping method effectiveness at short term (1 month) and medium term (6 months) - pain, disability and quality of live - in patients with chronic low back pain.
- Secondary objective: To analyze the influence of fear-avoidance beliefs, catastrophizing ideas and anxiety-depression presence in kinesio taping method effectiveness for chronic low back pain patients.
Method:
Chronic low back pain patients are recruited from the outpatient rehabilitation service of a health area of Valencia which serves a population of 320,000 inhabitants.
The study has been planned for a difference of 3 points in the Roland Morris questionnaire, as these values have been recognized as clinically relevant . Considering an alpha of 0.05 and beta of 0.9 for comparison of means of two tails , 24 patients per group is the required sample size to detect changes in disability. Considering a loss of 20 % of the participants, the study sample is set to 62 patients.
Addressing the CONSORT guidelines, a flow chart describing the situation during the course of the trial is draw; including all patients invited , the number of those who refuse to participate before randomization , the assignment to each treatment arm, losses during follow-up and possible crosslinking.
Patients who agree to participate in the study are randomly assigned to one of two intervention groups. The allocation was made by a list generated by computer using the Statistical Package for the Social Sciences (SPSS 19), supervised by an statistical outside of the investigator team . Concealment of randomization sequence is maintained with hidden cards in numbered opaque envelopes.
The duration of treatment is 4 weeks , changing the tape with a weekly frequency. Basic rules of postural control and stabilization and the pattern of exercises proposed by the Spanish Society for Rehabilitation and Physical Medicine are given prior to randomization.
The evaluation of results is done through self-administered questionnaires to be completed by the patients ever before clinic visits .
The primary results will be obtained by intention to treat analysis. Descriptive statistics will be obtained expressing continuous variables in mean (standard deviation) or median (quartiles) according to their normal or not, categorical variables in number (percentage) and expressing in all cases the confidence interval of 95%. The normal distribution was checked by Kolmogorov test to determine the use of parametric or non-parametric tests. For comparison of continuous variables between groups the Student t test or the Mann-Whitney test will be used according to the type of distribution. For comparison of categorical variables the chi-square test or Fisher will be used test according to the type of distribution. Changes in intra-group in continued variables at 4 weeks and 6 months will be analyzed with the Student t test for paired samples variables. To assess whether there are differences between the two groups in pain, disability and different variables analysis of covariance (ANCOVA) will be held, one for each dependent variable. In all tests, the independent variable is the group, while the covariate variable will be the baseline for each dependent variable. It will be necessary to have comparable levels in both groups to correctly interpret the results of ANCOVA. Therefore, several Student t tests, one for each dependent variable considering each group as an independent variable in each case, will be made. To assess whether changes in the 2 groups are produced differently, multiple ANOVA analysis for each dependent variable will be performed. In all cases, the independent variable is the group and the time data are collected. This analysis examines only the possible presence of interactions. In addition, correlations between the study variables will be evaluated, using Pearson's r or Rho Spearman according to the type of distribution. Two models of multiple linear regression will be applied with pain and disability as dependent variables and age, sex, pain catastrophizing, fear-avoidance, sick leave, time to progression, anxiety-depression as independent variables.
The project will follow existing in Spain and the European Union guidelines for the protection of patients in clinical trials with respect to collection, storage and custody of personal data.
All eligible patients are given oral and written information ( informed consent) about the study and the two treatment modalities. Specifically they are informed about they can leave the study at any time without giving any explanation and that this decision will not affect the continuation of his regular treatment.
- Conditions
- Chronic Low Back Pain
- Being tested
- Kinesio Taping method, Kinesio Taping sham
- Keywords
- Kinesio taping, Neuromuscular taping, Targeted treatment, Chronic low back pain, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Taping methodDevice
The tape is applied depending on the physical examination:
- Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively.
- Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point.
- Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers.
Kinesio Taping shamDevice
The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping method | Experimental | The tape is applied depending on the physical examination:
* Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively.
* Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point.
* Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers. Receives: Device: Kinesio Taping method |
| Kinesio Taping sham | Sham comparator | The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position. Receives: Device: Kinesio Taping sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Roland Morris Disability Questionnaire"
Assess activity limitations due to back pain. Consists of 24 statements. Patients were asked to answer yes or no to each statement. Each positive answer is worth one point with scores ranging from 0 (no disability) to 24 (severely disabled). The Spanish version has been validated.
Measured: pretreatment, 4 weeks, 6 month
Secondary outcomes (3)
Change in "Fear Avoidance Beliefs Questionnaire"
measure fear and avoidance beliefs related to low back pain. It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items). The patient has to rate each sentence from 0 (totally disagree) to 6 (totally agree). The score range is 0 to 96, with a higher value reflecting a higher degree of fear avoidance beliefs. Two subscales are defined. "Factor 1" is composed of items 6, 7, 9, 10, 11, and 12 and reflects fear-avoidance beliefs about work. "Factor 2" is composed of items 2 to 5 and reflects fear-avoidance beliefs about physical activities. The Spanish version has been validated.
Measured: pretreatment, 4 weeks, 6 month
Change in "Pain Catastrophizing Scale"
This scale assess patient negative and exaggerated orientation to painful stimuli. It has 13 item and comprises three dimensions: a) rumination; b) magnification, and c) hopelessness. Each item scores on a 5-point Likert scale (0 not at all 1 a little, 2 moderately, 3 very much, 4 all the time. The score range is 0 to 52, with a higher value reflecting a higher degree of pain catastrophizing. The Spanish version has been validated
Measured: pretreatment, 4 weeks, 6 month
Change in "Hospital Anxiety and Depression subscale"
This scale is used for screening mood and anxiety disorders. Consists of a 7-item anxiety subscale and a 7-item depression subscale. Each item scores on a 4-point Likert scale (0 as much as I always do; 1 not quite so much; 2 definitely not so much; 3 not at all ), giving maximum subscale scores of 21 for depression and anxiety, respectively. The Spanish version has been validated.
Measured: pretreatment, 4 weeks, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start15 Dec 2015
- Primary completion15 Sep 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Collaborators
- Cardenal Herrera University, Hospital Arnau de Vilanova
- Responsible party
- Principal investigator, Julio Domenech, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- María Lourdes Peñalver Barrios, MD, Principal investigator, Hospital Arnau de Vilanova, Valencia, SpainJulio Domenech Fernández, MD, PhD, Study director, Hospital Arnau de Vilanova, Valencia, SpainJuan Francisco Lisón Párraga, MD, PhD, Study director, Cardenal Herrera CEU University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604290
- Sponsor's protocol ID
- MSK063
- Acronym
- KITALO
- Status last verified
- Apr 2019
- First submitted
- 10 Nov 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010 Apr 8;8:22. doi: 10.1186/1741-7015-8-22.
PubMed 20377854Parreira Pdo C, Costa Lda C, Hespanhol LC Jr, Lopes AD, Costa LO. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. J Physiother. 2014 Mar;60(1):31-9. doi: 10.1016/j.jphys.2013.12.008. Epub 2014 Apr 24.
PubMed 24856938Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.
PubMed 21430611Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.
PubMed 22613238Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
PubMed 25202177Parreira Pdo C, Costa Lda C, Takahashi R, Hespanhol Junior LC, Luz Junior MA, Silva TM, Costa LO. Kinesio taping to generate skin convolutions is not better than sham taping for people with chronic non-speci fi c low back pain: a randomised trial. J Physiother. 2014 Jun;60(2):90-6. doi: 10.1016/j.jphys.2014.05.003. Epub 2014 Jun 10.
PubMed 24952836
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Method for Chronic Mechanical Low Back Pain: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02604290
- Acronym / sponsor ID
- KITALO / MSK063
- Conditions
- Chronic Low Back Pain
- Keywords
- Kinesio taping, Neuromuscular taping, Targeted treatment, Chronic low back pain, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Collaborators
- Cardenal Herrera University, Hospital Arnau de Vilanova
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 13 Nov 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.
The purpose of this study is to determine whether the kinesio taping method is effective in the treatment of chronic (more than six months duration) low back pain.
Detailed description
Hypothesis: Kinesio taping treatment in patients with chronic low back pain, in which fascial mobilisation represents a treatment effect modifier, reduces pain and disability and improves quality of live, in comparison with simulated kinesio taping.
Objective:
- Primary objective: To evaluate kinesio taping method effectiveness at short term (1 month) and medium term (6 months) - pain, disability and quality of live - in patients with chronic low back pain.
- Secondary objective: To analyze the influence of fear-avoidance beliefs, catastrophizing ideas and anxiety-depression presence in kinesio taping method effectiveness for chronic low back pain patients.
Method:
Chronic low back pain patients are recruited from the outpatient rehabilitation service of a health area of Valencia which serves a population of 320,000 inhabitants.
The study has been planned for a difference of 3 points in the Roland Morris questionnaire, as these values have been recognized as clinically relevant . Considering an alpha of 0.05 and beta of 0.9 for comparison of means of two tails , 24 patients per group is the required sample size to detect changes in disability. Considering a loss of 20 % of the participants, the study sample is set to 62 patients.
Addressing the CONSORT guidelines, a flow chart describing the situation during the course of the trial is draw; including all patients invited , the number of those who refuse to participate before randomization , the assignment to each treatment arm, losses during follow-up and possible crosslinking.
Patients who agree to participate in the study are randomly assigned to one of two intervention groups. The allocation was made by a list generated by computer using the Statistical Package for the Social Sciences (SPSS 19), supervised by an statistical outside of the investigator team . Concealment of randomization sequence is maintained with hidden cards in numbered opaque envelopes.
The duration of treatment is 4 weeks , changing the tape with a weekly frequency. Basic rules of postural control and stabilization and the pattern of exercises proposed by the Spanish Society for Rehabilitation and Physical Medicine are given prior to randomization.
The evaluation of results is done through self-administered questionnaires to be completed by the patients ever before clinic visits .
The primary results will be obtained by intention to treat analysis. Descriptive statistics will be obtained expressing continuous variables in mean (standard deviation) or median (quartiles) according to their normal or not, categorical variables in number (percentage) and expressing in all cases the confidence interval of 95%. The normal distribution was checked by Kolmogorov test to determine the use of parametric or non-parametric tests. For comparison of continuous variables between groups the Student t test or the Mann-Whitney test will be used according to the type of distribution. For comparison of categorical variables the chi-square test or Fisher will be used test according to the type of distribution. Changes in intra-group in continued variables at 4 weeks and 6 months will be analyzed with the Student t test for paired samples variables. To assess whether there are differences between the two groups in pain, disability and different variables analysis of covariance (ANCOVA) will be held, one for each dependent variable. In all tests, the independent variable is the group, while the covariate variable will be the baseline for each dependent variable. It will be necessary to have comparable levels in both groups to correctly interpret the results of ANCOVA. Therefore, several Student t tests, one for each dependent variable considering each group as an independent variable in each case, will be made. To assess whether changes in the 2 groups are produced differently, multiple ANOVA analysis for each dependent variable will be performed. In all cases, the independent variable is the group and the time data are collected. This analysis examines only the possible presence of interactions. In addition, correlations between the study variables will be evaluated, using Pearson's r or Rho Spearman according to the type of distribution. Two models of multiple linear regression will be applied with pain and disability as dependent variables and age, sex, pain catastrophizing, fear-avoidance, sick leave, time to progression, anxiety-depression as independent variables.
The project will follow existing in Spain and the European Union guidelines for the protection of patients in clinical trials with respect to collection, storage and custody of personal data.
All eligible patients are given oral and written information ( informed consent) about the study and the two treatment modalities. Specifically they are informed about they can leave the study at any time without giving any explanation and that this decision will not affect the continuation of his regular treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping method | Experimental | Device: Kinesio Taping methodThe tape is applied depending on the physical examination: * Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively. * Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point. * Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers. |
| Kinesio Taping sham | Sham comparator | Device: Kinesio Taping shamThe tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years.
- Chronic low back pain least 6 months duration.
- Improvement of pain with mobilization of skin/fascias in physical examination.
- Signature of informed consent.
Key exclusion criteria (5 listed)
- Having had previous treatment experience with kinesio taping method.
- Presence of components of neuropathic pain (radiculopathy, lumbar canal stenosis).
- Specific origin pain (vertebral fracture, tumor or nerve column structures, spondyloarthropathy, spondylodiscitis).
- Prior spine surgery.
- Mental retardation, severe mental illness, substance abuse or dependency, illiteracy.
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 Taping methodThe tape is applied depending on the physical examination: * Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively. * Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point. * Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers. | Device | Kinesio Taping method |
| Kinesio Taping shamThe tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position. | Device | Kinesio Taping sham |
Primary outcome
Change in "Roland Morris Disability Questionnaire"
Time frame: pretreatment, 4 weeks, 6 month
Assess activity limitations due to back pain. Consists of 24 statements. Patients were asked to answer yes or no to each statement. Each positive answer is worth one point with scores ranging from 0 (no disability) to 24 (severely disabled). The Spanish version has been validated.
3 secondary outcomes
Change in "Fear Avoidance Beliefs Questionnaire"
Time frame: pretreatment, 4 weeks, 6 month
Change in "Pain Catastrophizing Scale"
Time frame: pretreatment, 4 weeks, 6 month
Change in "Hospital Anxiety and Depression subscale"
Time frame: pretreatment, 4 weeks, 6 month
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 16 Apr 2019.
- Background: PubMed 20377854Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010 Apr 8;8:22. doi: 10.1186/1741-7015-8-22.
- Background: PubMed 24856938Parreira Pdo C, Costa Lda C, Hespanhol LC Jr, Lopes AD, Costa LO. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. J Physiother. 2014 Mar;60(1):31-9. doi: 10.1016/j.jphys.2013.12.008. Epub 2014 Apr 24.
- Background: PubMed 21430611Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.
- Background: PubMed 22613238Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.
- Background: PubMed 25202177Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
- Background: PubMed 24952836Parreira Pdo C, Costa Lda C, Takahashi R, Hespanhol Junior LC, Luz Junior MA, Silva TM, Costa LO. Kinesio taping to generate skin convolutions is not better than sham taping for people with chronic non-speci fi c low back pain: a randomised trial. J Physiother. 2014 Jun;60(2):90-6. doi: 10.1016/j.jphys.2014.05.003. Epub 2014 Jun 10.
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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.
María Lourdes Peñalver Barrios, MD principal investigator
Hospital Arnau de Vilanova, Valencia, Spain
Julio Domenech Fernández, MD, PhD study director
Hospital Arnau de Vilanova, Valencia, Spain
Juan Francisco Lisón Párraga, MD, PhD study director
Cardenal Herrera CEU 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 method in people with Chronic Low Back Pain, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana 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 4 inclusion and 5 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 16 Apr 2019. 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.
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?
Change in "Roland Morris Disability Questionnaire" (time frame: pretreatment, 4 weeks, 6 month). 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 NCT02604290, which also lists 6 linked publications.
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 16 Apr 2019.