Low Back PainNCT02982382
Effects of Manipulative Therapy and Pain Education in Individuals With CLBP
A study testing Manipulative Therapy and Pain Education in people with Low Back Pain, run by Santa Catarina Federal University at 1 site in Brazil.
Trial summary
The burden of low back pain more than doubled in the last 20 years, probably caused by biopsychosocial factors. Some noninvasive treatments have been applied in individuals with chronic nonspecific low back pain as spinal manipulation and pain education. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manipulative Therapy and Pain Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic episodes of nonspecific LBP for at least six months
- Pain on movement for at least one direction (flexion, extension, side bending or rotation of the trunk)
- At least score 3 in NPRS.
Who cannot join
- 1) Previous history of lumbar myelopathy, rheumatic disease, tumors, peripheral or central neurological disorders
- 2) Historical of trauma, fracture or surgery in lumbar region;
- 3) Nerve root compression signs: important muscle weakness affecting lower limb, decrease or abolish of patellar and calcaneus reflex and decrease of dermatomes sensibility of lower limbs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Catarina Federal University
Florianópolis, Santa Catarina, 88040-900
About this study
Official title: Neurophysiological and Functional Effects of Manipulative Therapy and Pain Education in Individuals With Chronic Nonspecific Low Back Pain
The burden of low back pain more than doubled in the last 20 years, probably caused by biopsychosocial factors. Some noninvasive treatments have been applied in individuals with chronic nonspecific low back pain as spinal manipulation and pain education. However, it is not already clear the neurophysiological effects of these treatments.The purpose of this research is to verify the effects of the technique of spinal manipulation and pain education in individuals with chronic low back pain
Read the detailed description
The outcomes will be subjective pain (measured by Numeric Pain Rating Scale), pressure pain threshold (measured by Algometer), disability (measured by Roland-Morris Disability Questionnaire), fear and avoidance beliefs (measured by Fear Avoidance Beliefs Questionnaire), risk of poor prognosis (measured by STarT Back Screening Tool), quality of life (measured by Short Form-12v2) and blood biomarkers (measured by ELISA). The data will be collected by a blinded assessor.
Individuals eligibility is going to be assessed by blinded assessor to determine if they are or not eligible for this research. Then, they will be informed about the objectives of this study and asked to sign the consent form. Afterward, the sociodemographic data will be recorded. The data related to the research outcomes will be collected by the blinded assessor at baseline assessment, after six weeks and three months.
Random Allocation Before the treatment begins, one of the researchers not involved in the recruiting and assessment will allocate the individuals in one of the groups. Block randomization will be used; it is going to generate by randomization.com, this site will create a list with the randomization sequence, which will be only seen by the physical therapists that will treat the individuals.
Statistical Methods
Sample size calculation The sample size calculation was calculated with the A-priori test with the following specifications: Statistical test ANCOVA, the effect size of 0.25, the statistical power of 80%, and an alpha level of 5%. As a result, the study requires a sample size of 64 per group or 128 individuals in total.
Analysis of effects of treatment Our research will use the intention-to-treat principles. The descriptive data and the scores of RMDQ, SBST, FABQ, SF-12v2 and NPRS as well as the pressure pain threshold means and the values of inflammatory biomarkers, before and after interventions, will be tabbed on Microsoft Excel 2010. To see the effect of treatment is going to be used statistical based on intention-to-treat principles, statistical analyses will be used to analyses data of individuals socio-demographics and clinics characteristics, and they will be presented by mean and standard deviation. To compare the groups, Shapiro-Wilk test will be applied to test the normality distribution of data, depending on this distribution will be used ANOVA one-way for parametric data or Kruskal-Wallis test for non-parametric data. To compare groups on the pre-intervention period another ANOVA-one way or another Kruskal-Wallis will be applied.
Covariance analysis (ANCOVA) will be conducted to assess the effect of treatment on the following outcomes: Scores obtained on RMDQ, FABQ, SF-12v2, SBST and NPRS, pressure pain threshold and the blood biomarkers concentrations, utilizing the post-treatment means as dependent variables, the pre-treatment means as co-variables and the group as fixed factor.
To the relationships among the variables must be applied the Pearson correlation coefficient to parametric data and Spearman correlation coefficient to nonparametric data. To classify the relationships will be used the Munro's classification, where values between 0.26 and 0.49 will be low, values between 0.50 and 0.69 will be moderate, between 0.70 and 0.89 will be high values, and between 0.90 and 1.0 will be considered very high. For all of these analyses will be used the Statistical Package for the Social Sciences (IBM SPSS version 20.0, IBM Corp, Armonk, New York).
- Conditions
- Low Back Pain
- Being tested
- Manipulative Therapy, Pain Education, Sham
- Keywords
- Low Back Pain, Musculoskeletal Manipulations, Neurophysiology, Education
- 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.
Manipulative TherapyOther
Also called Manual Therapy, Grade V Manipulation, Spinal Manipulation
Subjects will receive techniques of High Velocity and Low Amplitude (HVLA) or grade V manipulation to the lumbar region (lumbar roll), and pain education based on the biopsychosocial approach.
Pain EducationOther
Also called Neuroscience Pain Education
Individuals will receive pain education based in a biopsychosocial approach
ShamOther
The individuals will receive a simulation of spinal manipulation (sham) involving manual contact over lumbar region totaling 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Manipulative Treatment | Experimental | Subjects will receive Manipulative Therapy Receives: Other: Manipulative Therapy; Other: Pain Education |
| Pain Education | Sham comparator | Subjects will receive Pain Education and manual contact over lumbar region Receives: Other: Pain Education; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Numeric Pain Rating Scale (NPRS)
Measured: 6 weeks after randomization
Secondary outcomes (7)
Pain Intensity
Numeric Pain Rating Scale (NPRS)
Measured: Baseline, 6 weeks and 3 months
Disabilty
Rolland Morris Disability Questionnaire (RMDQ)
Measured: baseline, 6 weeks and 3 months
Pressure Pain Threshold
The pressure pain threshold will be assessed by algometer. It will be realized three times in each point (Five centimeters of the right and left side of the spinal process of L1, L3 and L5, and on the muscle belly of tibialis anterior).
Measured: Baseline, 6 weeks and 3 months
Fear and Beliefs about pain
Fear Avoidance Belief Questionnaire (FABQ)
Measured: Baseline, 6 weeks and 3 months
Risk of poor prognosis
STarT Back Screening Tool (SBST)
Measured: Baseline, 6 weeks and 3 months
Quality of Life
Short-Form Health Survey 12 version 2 (SF-12v2)
Measured: Baseline, 6 weeks and 3 months
Serum Level of Cytokines
Enzyme Linked Immunosorbent Assay (ELISA) to TNF-α, IL-1β, IL-4, IL-6, IL-8, IL-12, IL-10, IL-15, MIP-4, CCL18, MCP-3 / CCL7, MCP-2 / CCL8, IGP - 10 / CXCL10, Stromal Lymphopoietin Receptor (TSLR), Interferon Gamma and CRP.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018
- Study completionDec 2018
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Catarina Federal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clecio Vier, Santa Catarina Federal University
- Investigators
- Clécio Vier, PhD Student, Principal investigator, Santa Catarina Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982382
- Sponsor's protocol ID
- Cvier
- Other IDs
- U1111-1190-4899
- Status last verified
- Feb 2019
- First submitted
- 29 Nov 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological and Functional Effects of Manipulative Therapy and Pain Education in Individuals With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT02982382
- Acronym / sponsor ID
- Cvier
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Musculoskeletal Manipulations, Neurophysiology, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Santa Catarina Federal UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Dec 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.
The burden of low back pain more than doubled in the last 20 years, probably caused by biopsychosocial factors. Some noninvasive treatments have been applied in individuals with chronic nonspecific low back pain as spinal manipulation and pain education. However, it is not already clear the neurophysiological effects of these treatments.The purpose of this research is to verify the effects of the technique of spinal manipulation and pain education in individuals with chronic low back pain
Detailed description
The outcomes will be subjective pain (measured by Numeric Pain Rating Scale), pressure pain threshold (measured by Algometer), disability (measured by Roland-Morris Disability Questionnaire), fear and avoidance beliefs (measured by Fear Avoidance Beliefs Questionnaire), risk of poor prognosis (measured by STarT Back Screening Tool), quality of life (measured by Short Form-12v2) and blood biomarkers (measured by ELISA). The data will be collected by a blinded assessor.
Individuals eligibility is going to be assessed by blinded assessor to determine if they are or not eligible for this research. Then, they will be informed about the objectives of this study and asked to sign the consent form. Afterward, the sociodemographic data will be recorded. The data related to the research outcomes will be collected by the blinded assessor at baseline assessment, after six weeks and three months.
Random Allocation Before the treatment begins, one of the researchers not involved in the recruiting and assessment will allocate the individuals in one of the groups. Block randomization will be used; it is going to generate by randomization.com, this site will create a list with the randomization sequence, which will be only seen by the physical therapists that will treat the individuals.
Statistical Methods
Sample size calculation The sample size calculation was calculated with the A-priori test with the following specifications: Statistical test ANCOVA, the effect size of 0.25, the statistical power of 80%, and an alpha level of 5%. As a result, the study requires a sample size of 64 per group or 128 individuals in total.
Analysis of effects of treatment Our research will use the intention-to-treat principles. The descriptive data and the scores of RMDQ, SBST, FABQ, SF-12v2 and NPRS as well as the pressure pain threshold means and the values of inflammatory biomarkers, before and after interventions, will be tabbed on Microsoft Excel 2010. To see the effect of treatment is going to be used statistical based on intention-to-treat principles, statistical analyses will be used to analyses data of individuals socio-demographics and clinics characteristics, and they will be presented by mean and standard deviation. To compare the groups, Shapiro-Wilk test will be applied to test the normality distribution of data, depending on this distribution will be used ANOVA one-way for parametric data or Kruskal-Wallis test for non-parametric data. To compare groups on the pre-intervention period another ANOVA-one way or another Kruskal-Wallis will be applied.
Covariance analysis (ANCOVA) will be conducted to assess the effect of treatment on the following outcomes: Scores obtained on RMDQ, FABQ, SF-12v2, SBST and NPRS, pressure pain threshold and the blood biomarkers concentrations, utilizing the post-treatment means as dependent variables, the pre-treatment means as co-variables and the group as fixed factor.
To the relationships among the variables must be applied the Pearson correlation coefficient to parametric data and Spearman correlation coefficient to nonparametric data. To classify the relationships will be used the Munro's classification, where values between 0.26 and 0.49 will be low, values between 0.50 and 0.69 will be moderate, between 0.70 and 0.89 will be high values, and between 0.90 and 1.0 will be considered very high. For all of these analyses will be used the Statistical Package for the Social Sciences (IBM SPSS version 20.0, IBM Corp, Armonk, New York).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulative Treatment | Experimental | Other: Manipulative Therapy, Other: Pain EducationSubjects will receive Manipulative Therapy |
| Pain Education | Sham comparator | Other: Pain Education, Other: ShamSubjects will receive Pain Education and manual contact over lumbar region |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic episodes of nonspecific LBP for at least six months
- Pain on movement for at least one direction (flexion, extension, side bending or rotation of the trunk)
- At least score 3 in NPRS.
Key exclusion criteria (3 listed)
- 1) Previous history of lumbar myelopathy, rheumatic disease, tumors, peripheral or central neurological disorders
- 2) Historical of trauma, fracture or surgery in lumbar region;
- 3) Nerve root compression signs: important muscle weakness affecting lower limb, decrease or abolish of patellar and calcaneus reflex and decrease of dermatomes sensibility of lower limbs.
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 |
|---|---|---|
| Manipulative TherapyAlso: Manual Therapy, Grade V Manipulation, Spinal ManipulationSubjects will receive techniques of High Velocity and Low Amplitude (HVLA) or grade V manipulation to the lumbar region (lumbar roll), and pain education based on the biopsychosocial approach. | Other | Manipulative Treatment |
| Pain EducationAlso: Neuroscience Pain EducationIndividuals will receive pain education based in a biopsychosocial approach | Other | Manipulative Treatment, Pain Education |
| ShamThe individuals will receive a simulation of spinal manipulation (sham) involving manual contact over lumbar region totaling 5 minutes. | Other | Pain Education |
Primary outcome
Pain Intensity
Time frame: 6 weeks after randomization
Numeric Pain Rating Scale (NPRS)
7 secondary outcomes
Pain Intensity
Time frame: Baseline, 6 weeks and 3 months
Disabilty
Time frame: baseline, 6 weeks and 3 months
Pressure Pain Threshold
Time frame: Baseline, 6 weeks and 3 months
Fear and Beliefs about pain
Time frame: Baseline, 6 weeks and 3 months
Risk of poor prognosis
Time frame: Baseline, 6 weeks and 3 months
Quality of Life
Time frame: Baseline, 6 weeks and 3 months
Serum Level of Cytokines
Time frame: Baseline, 6 weeks
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 25 Feb 2019.
Related trials for Low Back Pain
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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.
Clécio Vier, PhD Student principal investigator
Santa Catarina Federal 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 Manipulative Therapy and Pain Education in people with Low Back Pain, run by Santa Catarina Federal 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 3 inclusion and 3 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 25 Feb 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 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: 6 weeks after randomization). 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 25 Feb 2019.